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Suture Material

The document provides a review of absorbable polymeric surgical sutures, including their chemistry, production, properties, biodegradability, and performance. It discusses the history and characteristics of suture materials and provides details on the introduction and commercial success of synthetic absorbable polymers like poly(glycolic acid).

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0% found this document useful (0 votes)
165 views76 pages

Suture Material

The document provides a review of absorbable polymeric surgical sutures, including their chemistry, production, properties, biodegradability, and performance. It discusses the history and characteristics of suture materials and provides details on the introduction and commercial success of synthetic absorbable polymers like poly(glycolic acid).

Uploaded by

Olea Scorpan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Review Paper: Absorbable

Polymeric Surgical Sutures:


Chemistry, Production, Properties,
Biodegradability, and Performance

CHENNAKKATTU KRISHNA SADASIVAN PILLAI AND


CHANDRA P. SHARMA*
Division of Biosurface Technology, Biomedical Technology Wing,
Sree Chitra Tirunal Institute for Medical Sciences & Technology,
Poojappura, Thiruvananthapuram 695 012, India

ABSTRACT: Among biomaterials used as implants in human body, sutures


constitute the largest groups of materials having a huge market exceeding
$1.3 billion annually. Sutures are the most widely used materials in wound
closure and have been in use for many centuries. With the development of the
synthetic absorbable polymer, poly(glycolic acid) (PGA) in the early 1970s, a new
chapter has opened on absorbable polymeric sutures that got unprecedented
commercial successes. Although several comparative evaluations of suture
materials have been published, there were no serious attempts of late on a
comprehensive review of production, properties, biodegradability, and perfor-
mance of suture materials. This review proposes to bring to focus scattered data
on chemistry, properties, biodegradability, and performance of absorbable
polymeric sutures.

KEY WORDS: polymeric sutures, absorbable, chemistry, properties,


biodegradation.

*Author to whom correspondence should be addressed.


E-mail: [email protected]
Figures 2–5 and 9 appear in color online: http://jba.sagepub.com

JOURNAL OF BIOMATERIALS APPLICATIONS Vol. 25 — November 2010 291


0885-3282/10/04 0291–76 $10.00/0 DOI: 10.1177/0885328210384890
ß The Author(s), 2010. Reprints and permissions:
http://www.sagepub.co.uk/journalsPermissions.nav

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292 C. K. S. PILLAI AND C. P. SHARMA

INTRODUCTION

A suture is a biomaterial device, either natural or synthetic, used to


ligate blood vessels and approximate tissues together [1]. Thus, its
major functions are to bring and hold tissues together following
separation by surgery or trauma. It can also denote the method used
for mechanical wound closure. The goals of wound closure include
obliteration of dead space, even distribution of tension along deep suture
lines, maintenance of tensile strength across the wound until tissue
tensile strength is adequate, and approximation of the epithelial portion
of the closure. Although there are other methods for mechanical wound
closure such as staples, tape, and adhesive [2], sutures are the most
widely used materials in wound closure. Sutures have registered
tremendous growth during the last two decades and have become the
largest group of biomaterials having a huge market exceeding
$1.3 billion annually [3–7]. Although several evaluations of suture
materials have been published [8–18], there were no serious attempts of
late on a comprehensive review of production, properties, biodegrad-
ability, and performance of suture materials. The purpose of this article
is, therefore, to systematically and comprehensively review all available
information generated in recent times covering all aspects on the
developments on chemistry, production, properties, biodegradability,
and performance of absorbable polymeric sutures. Comparative evalua-
tions with other sutures have also been made at appropriate places
wherever it is required.
A comparative evaluation in general on various closure materials used
in vascular devices was published by Hon et al. [10] in 2009. They
provided an overview of sutures used in vascular devices, focusing on
how they work, their efficacy in achieving hemostasis, any risks
associated with their use, and indications as to which should be used
for particular indications. Li and Yuan [8] brought out a review in 2006
on research progresses on synthetic absorbable polymeric sutures. In
2002, Gassner [12] reviewed the area of wound closure materials.
A review with substantial input on biodegradability and emerging
trends on sutures was published by Singhal et al. in 1988 [4]. They have
brought out the salient features of absorbable sutures based on
poly(glycolic acid) (PGA) and its copolymers and mentioned the
coming of the promising polydioxanone (PDO; certain authors use
PDS to indicate polydioxanone suture) and poly(trimethylene carbonate)
(PTMC) based absorbable sutures.
Horacek [9] indicated that the absorbable sutures are based mostly on
the lower -hydroxycarboxylic acids and copolydioxanes. Some of the

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Absorbable Polymeric Surgical Sutures 293

properties and uses of suture materials have been reviewed by Yu and


Cavaliere [11]. Otherwise, one depends mostly on the classic book on
closure materials published in 1996 by Chu et al. for reference [1].
Benicewicz and Hopper [15] and later Jodar et al. [16–18] discussed the
nature of synthetic suture materials.
Guidelines for choice in regard to wound healing, location of incision,
and surgical needles and the difference between various absorbable and
nonabsorbable sutures are discussed in the review by Swanson and
Tromovitch [19]. Vogt et al. [20] summarized the current experimental
and clinical bases of surgical scar management in a recent review.

CHARACTERISTICS OF SUTURE MATERIALS

The ideal suture would be totally biologically inert and should not
cause any tissue reaction. It would be easy for the surgeon to handle and
knot it reliably. An ideal suture should have the following characteristics
[1,4,5,9–11]:
1. easy to handle
2. elicit minimal tissue reaction
3. does not support bacterial growth
4. possess high tensile strength
5. easy to sterilize
6. elicit no allergic reaction
7. elicit no carcinogenic action
8. absorbed after serving its function
Thus, a suture should not only be very strong but also be able to
simply dissolve in body fluids and lose strength at the same rate that the
tissue gains strength. It would neither cause nor promote complications
[21]. In short, sutures should provide the most secure wound
approximation for an adequate time with minimal adverse effect on
the normal wound healing process. Additional factors such as presence
of infection, tissue characteristics, and wound location, tension on
wound edges, age, and medical condition of patient, cosmoses, color,
speed, and cost are considered by Bennett [22].
Obviously, there is no single suture material which can fulfill all these
criteria [1]. The surgeon should choose the right suture for the type of
surgery that he/she is performing because different tissues have
differing requirements for suture support (some needing only a few
days, e.g., muscle, subcutaneous tissue, skin, while others require weeks
or even months, e.g., fascia and tendon). In addition, healing rates of
various tissues also will differ depending on various factors such as

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294 C. K. S. PILLAI AND C. P. SHARMA

infection, debility, respiratory problems, obesity, collagen disorders,


malnutrition, malignancy, drugs, for example cytotoxics and steroids [1].
The present surgeon has several choices of suture material available and
he may choose them based on availability and his familiarity. There are
some characteristics which are essential for all sutures. They include:
sterility, uniform diameter and size, pliability for ease of handling and
knot security, uniform tensile strength by suture type and size, and
freedom from contaminants that would elicit tissue reaction. To make it
explicit, the various terms used to characterize suture materials are
described in Table 1 [1,5,15,16,19,21,22]. Proper suturing technique is
essential for obtaining good cosmetic results and avoiding scarring and
poor wound healing. Techniques that must be mastered include good
eversion of skin edges, avoiding suture marks, maintaining uniform
tensile strength along the skin edges, and precise approximation along
skin edges [5].

HISTORY OF SUTURE MATERIALS

Suturing is not a new technique but is a known procedure since


ancient era. This is the branch basically evolved for the purpose of
wound healing and its management [23]. Physicians have been using
sutures for at least 4000 years [24]. Archaeological records from ancient
Egypt and India show the use of linen, animal sinew, flax, hair, grass,
cotton, silk, pig bristles, and animal gut to close wounds [24,25]. The
famed Sushruta is reported to have used suture materials of bark,
tendon, hair, and silk as sutures in surgery [26–30].
The first detailed description of a wound suture and the suture
materials used in it is described by Sushruta in Sushruta Samhita,
written in 500 BCE. Since he was the author of the earliest systematic
report, it is assumed that in the case of Egyptian, Babylonian, Greek,
and Arab surgeries, all have their origins in India [30]. The ancient
Greek physician Claudius Galen (131–211 CE) was the first to describe
the chorda or gut string as a suture material. The surgeon Antyllus (300
CE) performed bone and joint resections, tracheotomies and the first
operations on traumatic aneurysms, using chorda material [31]. The use
of dried sheep intestine (for ligatures in surgical operations) is advised in
Vagbhataratha Kaumudi (700 AD), a commentary by Harikrishna on
Astanga Hridaya of Vaghbhata-II [32] and in similar works [33–36]. In
Europe, Salerno and Rogerio recommended gut strings as suture
material, especially for wounds at the large abdominal viscera.
Abulcasim (second half of the 10th century), the famous Arab surgeon,
produced a detailed description of suture techniques. The Frenchman

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Absorbable Polymeric Surgical Sutures 295

Table 1. Terms describing the various characteristics related to suture materials


[1,5,15,16,19,21,22].

No. Term Description


1. Absorbable Progressive loss of mass and/or volume of suture material;
does not correlate with initial tensile strength
2. Breaking strength Limit of tensile strength at which suture failure occurs
3. Capillarity Extent to which absorbed fluid is transferred along the
suture
4. Elasticity Measure of the ability of the material to regain its original
form and length after deformation
5. Fluid absorption Ability to take up fluid after immersion
6. Knot-pull tensile Breaking strength of knotted suture material (10–40%
strength weaker after deformation by knot placement)
7. Knot strength Amount of force necessary to cause a knot to slip (related
to the coefficient of static friction and plasticity of a given
material)
8. Memory Inherent capability of suture to return to or maintain its
original gross shape (related to elasticity, plasticity, and
diameter)
9. Nonabsorbable Surgical suture material that is relatively unaffected by the
biological activities of the body tissues and is therefore
permanent unless removed
10. Plasticity Measure of the ability to deform without breaking and to
maintain a new form after relief of the deforming force
11. Pliability Ease of handling of suture material; ability to adjust knot
tension and to secure knots (related to suture material,
filament type, and diameter)
12. Straight-pull tensile Linear breaking strength of suture material
strength
13. Suture pullout value The application of force to a loop of suture located where
tissue failure occurs, which measures the strength of a
particular tissue; variable depending on anatomic site
and histological composition (fat, 0.2 kg; muscle,
1.27 kg; skin, 1.82 kg; fascia, 3.77 kg)
14. Tensile strength Measure of a material or tissue’s ability to resist
deformation and breakage
15. Wound breaking Limit of tensile strength of a healing wound at which
strength separation of the wound edges occurs

Ambroise Paré (1510–1590), who originally was a barber, became one of


the greatest surgeons of all times, used fine linen strips and silk for
vascular ligatures [14–19,22,37]. Joseph Lister introduced the first
catgut suture sterilized with carbolic acid in 1860 and the chromic
catgut (CG) in 1880 [38,39]. To avoid a detailed historical description
which is not intended in this review, a time scale of the appearance of
various suture materials in use is shown in Tables 2–4 [5,22,31,38–45].

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296 C. K. S. PILLAI AND C. P. SHARMA

Table 2. Absorbable natural sutures [31,38,39].

Year Name of suture Trade name Manufacturer


16th century Catgut, plain, Catgut or surgical Astra, Ethicon, D/G, SSC,
SurgigutÕ catgut, twisted Kollsut, DemeTech
multifilament
1880 Chromic catgut Catgut or surgical Astra, Ethicon, D/G, SSC,
catgut, twisted Kollsut, DemeTech,
multifilament Sutures India Private
Limited, Bangalore,
Futura Surgicare Pvt.
Ltd., Bangalore,
MedSurge Ind Pvt Ltd,
Chennai
SurgigutÕ Twisted multifilament, USS
plain and chromic
SoftgutÕ Glycerin coated D/G
1950–1960 Collagen sutures Collagen, twisted Ethicon
multifilament, plain
and chromic.

These tables also provide trade names and the firms that manufacture
the sutures.
By 1900, the catgut industry was firmly established in Germany due
to the use of sheep intestines in their sausage industry. Many methods of
sterilizing were used but the introduction of iodine sterilization by
Claudius in 1902 established what was to become the standard method
of preparation for nearly half a century [46]. Buckskin and silver wire
were developed in the 18th century whereas chemical modifications
were effected on catgut during the 19th century. Cotton and treated
natural materials were used in the 20th century as suturing materials.
The introduction of steel wire and synthetic nonabsorbable fibers like
nylon, polyester, and polypropylene (PP) during World War II greatly
expanded the chemical composition of suture materials. The year 1906
witnessed the development of the first truly sterile catgut sterilized by
sporicidal treatment with iodine following the suggestion of the German
surgeon Franz Kuhn (1866–1929) and Braun [31], Melsungen, Germany
started the industrial-scale production of Kuhn Catgut in 1908. Catgut
and silk dominated the suture market until 1930. The time scale of the
appearance of absorbable sutures after the discovery of PGA in 1968/
1970 is given in Table 3 [5,22,31,41–45]. Catgut is phased out in many
countries, because the risk of Creutzfeldt–Jakob Disease (CJD) infection
is still higher than with modern synthetic suture materials, even with
improved sterilization processes.

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Absorbable Polymeric Surgical Sutures 297

Table 3. Absorbable synthetic sutures [5,22,31,41–45].

Year Name of suture Trade name Manufacturer


1931 Polyvinyl alcohol HS-PVA braids (ref 101, Hefei Zheng’an Trading
p 382- Chu) Co., Ltd. (fiber
producer)
1968/70 Polyglycolide (PGA) DexonÕ – braided multi Monofilament
filament, Dexon PlusÕ –
braided multi filament
with surface treatment
with polyoxyethylneoxy
propylene, Dexon IIÕ –
braided multi filament
with surface treatment
with polycaprolate
Japan Medfical
1974 Polyglycolide (PGA) MedifitÕ Supplies
Polyglycolide (PGA) SafilÕ Quick – braided and B. Braun
coated suture (low
molecular weight)
Polyglycolide (PGA) SafilÕ – braided multi B. Braun
filament with surface
treatment
DemeTech’s PGA DemeTech, Unilene,
Yancheng huida
medical instruments
co., Ltd, SSM Sterile
RastoroTM Sutures Health Products INC,
Poly(glycolide-L-lactide) Polyglactin 910 (VicrylÕ ) – Ethicon
Braided multi filament
with surface treatment
with polyglactin 370 and
calcium stearate
1981 Poly(glycolide-L-lactide) PolysorbÕ – Braided multi US Surgicals
filament with surface
treatment.
TM
1981 Poly(glycolide-L-lactide) Radik Sutures Ethicon
PDS PDS IIÕ – monofilament B. Braun
PDS MonoPlusÕ – monofilament
1984 Polyglyconate MaxonÕ , monofilament D/G
Poly(glycolide co-TMC) MonosynÕ , monofilament B. Braun Melsungen AG
1987 Poly(glycolide-L-lactide) Polyglactin 910, VicrylÕ Ethicon
Rapid, an irradiated
version of the suture to
increase the rate of
degradation;
Vicryl PLUS- impregnated
with triclosan to provide
antimicrobial protection
(continued)

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298 C. K. S. PILLAI AND C. P. SHARMA

Table 3. Continued.

Year Name of suture Trade name Manufacturer


PANACRYLs is another
commercially developed
suture from the co-
polymer with a higher
LA/GA ratio in order to
decrease the rate of
degradation
1992 Poly(glycolide Co-e- Polyglecapron 25, Ethicon
caprolactone (MonocrylÕ ) –
monofilament
1998 Polyglycolic acid SerafitÕ , coated braided Ethical Agents Ltd.
Braid has pliability, high
knot pull tensile strength
1999 Poly(dioxinone co- trim Glycomer 631, BiosynÕ , USS
ethylene carbonate- Lactomer 9-1 PolysorbÕ ,
co-glycolide) Calcium stearoyl lactylate
Glykomer 631 coating
(BiosynÕ )
Poly(glycolide-L-lactide) USS
2000 Poly(glycolide co-TMC) (MonosynÕ ) B. Braun Melsungen AG
Glyconate SafilÕ quick, braided and B. Braun Melsungen AG
coated
Polyglycolic acid

CHARACTERIZATION OF SUTURE MATERIALS

Suture materials are characterized by various methods involving


physical and mechanical properties, handling characteristics, and
biological and biodegradation behavior. In any specification, the size of
the material should be mentioned. Similarly, whether the material is
mono- or multi-filament or braided, etc. needs to be mentioned.
Mechanical properties such as tensile strength, percentage elongation,
modulus of elasticity, stress relaxation, and creep are measured routinely.
The strength property is the most frequently reported mechanical
characteristics of suture materials. There must be a proper match
between the suture strength and the tissue strength [40]. Owing to the
critical nature of the suture function, it is often said that the life of a
patient hangs by a tiny thread. Strength includes knotted and unknotted
(straight pull) tensile strengths. As capillarity is related to the ability to
transport bacteria, it also needs to be measured. Other parameters
measured are swelling and coefficient of friction. Pliability, packaging
memory, knot security, knot tie-down, knot slippage, tissue drag, etc., are

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Absorbable Polymeric Surgical Sutures 299

Table 4. Nonabsorbable sutures [5,22,31,40,41,45].

Year Name of suture Trade name Manufacturer


1935/39 Polyamide Ethilon, Nylon 6 and Nylon 66, Ethicon
monofilament
Nurolon, Nylon 6 and Nylon 66, Ethicon
braided multifilament, coated.
SurgilonÕ Braided Multi-Filament, D/G
Silicone coated
DermalonÕ monofilament, D/G
BralonÕ braided monofilament USS
coated,
SutronÕ monofilament SSC
(NylonÕ , PerlonÕ ) Coated/ Astra
Polyamide thread SupramidÕ )
very fine yarned polymide 6/6
fibers which are sheathed with
seamless polymide 6 coating
SurulonÕ monofilament Suru International
Pvt. Ltd.
1939–1945 Tantalum SynthofilÕ , braided, coated B. Braun
uniformly with Polyethylene vinyl
acetate (PEVA) to improve
handling and knotting behavior
EthibondÕ Ethicon
SurgidacÕ USS
1950/57 Polyethylene/ ProleneÕ , monofilament Ethicon
Polypropylene
SurgileneÕ , monofilament D/G
SurgiproÕ monofilament USS
DuracareÕ monofilament Futura Surgicare
1960 Polyester
1966 V2A-Steel SynetureTM
2000 Polybutester
(NovafilÕ ,
VascufilÕ )

used to understand handling characteristics that are related to the ‘‘feel’’


of suture materials by surgeons during wound closure. Suture needles are
made of stainless or carbon steel. The needles may be nickel-plated or
electroplated. Packaging material includes water-resistant foil, such as
aluminum foil as well as cardboard and plastic [41].

SELECTION OF WOUND CLOSURE MATERIALS

Selection of wound closure materials for the procedure at hand may be


one of the most critical decisions the surgeon has to face in the operating

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300 C. K. S. PILLAI AND C. P. SHARMA

room [5,22]. Apart from personal preferences, the final choice will
depend upon various patient factors that influence the healing process,
the characteristics of the tissues involved, and potential post-operative
complications [42,47–49]. Both optimal wound closure and as unob-
structive scars as possible are of high significance after plastic-
reconstructive surgeries. Untearable, absorbable, as thin as possible,
monophile sutures with atraumatic needle-suture combinations as
offered by various manufactures should be preferred. A perfect
technique closing the wound intracutaneously in two layers should be
taken for granted today. The task of suture selection is complicated by
the wide variety of suturing materials available. Selection of sutures
inappropriate in size or number may increase the risk of complication
and delay healing [50,51].
Certain guiding principles for selecting a suture material for a given
task have emerged [22,43,48,51,52]. When a wound reaches maximal
strength, sutures are no longer needed. Therefore, it would be better to
close slow-healing tissues (skin, fascia, and tendons) with nonabsorbable
sutures or long-lasting absorbable sutures or close fast healing tissues
(stomach, colon, and bladder) with absorbable sutures. Foreign bodies in
potentially contaminated tissues may convert contamination into
infection. This indicated that one has to avoid multifilament sutures
which may convert contaminated wound into an infected one or use
monofilament sutures or absorbable sutures which resist harboring
infection. Where cosmetic results are important, close and prolonged
apposition of tissues and avoidance of irritants will produce the best
results. In such situations, use the smallest inert monofilament suture
materials (nylon, PP) and avoid using skin sutures alone and close
subcuticularly whenever possible. Similarly, foreign bodies in the
presence of fluids containing high crystalloid concentrations may
cause precipitation and stone formation. Then, it is advised to use
absorbable sutures in the urinary and biliary tracts. For selecting suture
size, use the finest sized suture commensurate with the natural strength
of the tissue to be sutured and use retention sutures to reinforce
appropriately sized primary sutures if the patient is at risk of producing
sudden strains on the suture line post-operatively. Remove the retention
sutures as soon as that risk is reduced.
The characteristics of commonly used suture materials and needles
are discussed by Bennet [22]. Grisham and Zukin [48] provide
enough information to make an informed choice of sutures when
repairing pediatric lacerations. Moy et al. [5] have discussed in detail
the scientific basis of selection of suture materials and they point out
that a proper suturing technique is essential for obtaining good

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Absorbable Polymeric Surgical Sutures 301

cosmetic results and avoiding scarring and poor wound healing.


Hochberg et al. [44], who reviewed the available materials for skin
closure, and their biomechanical properties, advantages, and dis-
advantages, proposed a pattern for better understanding of the
limitations, indications, and numerous choices to be considered
before choosing a suture material. Cost-effective and practical
solutions are discussed by Williams and Armstrong [53]. There is
widespread consensus among cutaneous surgeons regarding optimal
suture selection and closure technique by anatomic location. Adams
et al. [54] point out that more experienced surgeons tend to repair
larger defects but, possibly because of their increased confidence and
skill, rely on less complicated repairs.

CLASSIFICATION

Sutures are, in general, categorized according to the type of material


(natural or synthetic), the lifetime of the material in the body
(absorbable or nonabsorbable), and the form in which they were
made (braided, twisted, and monofilament) [1,5]. Suture manufactur-
ing comes under the regulatory control of the Food and Drug
Administration (FDA) because sutures are classified as medical
devices. Manufacturing guidelines and testing for the industry is
provided by a nonprofit, non-governmental agency called United States
Pharmacopeia (USP), located in Rockville, MD. The USP system was
established in 1937 for standardization and comparison of suture
materials, corresponding to metric measures. The three classes of
sutures are collagen, synthetic absorbable, and nonabsorbable. They
are as follows:
. Class I – Silk or synthetic fibers of monofilament, twisted, or braided
construction.
. Class II – Cotton or linen fibers or coated natural or synthetic fibers
in which the coating contributes to suture thickness without adding
strength.
. Class III – Metal wire of monofilament or multifilament construction.
Size refers to the diameter of the suture strand and is denoted as
zeroes. The more zeroes characterizing a suture size, the smaller
the resultant strand diameter (e.g., 4-0 is larger than 5-0). The smaller
the suture, the lesser the tensile strength of the strand. These size
details are provided in Table 5 and the uses of different sizes of suture in
Table 6 [1,5].

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302 C. K. S. PILLAI AND C. P. SHARMA

Table 5. Suture size classification as per USP and their use [1,5].

U.S.P. suture size Average minimum (kgf) Individual minimum (kgf)


11-0 0.007 0.005
10-0 0.014 0.010
9-0 0.021 0.015
8-0 0.050 0.025
7-0 0.080 0.040
6-0 0.170 0.080
5-0 0.230 0.110
4-0 0.450 0.230
3-0 0.680 0.340
2-0 1.100 0.450
0 1.500 0.450
1 1.800 0.600
2þ 1.800 0.700

Table 6. Uses of different sizes of suture.

Size Uses
7/0 and smaller Ophthalmology, microsurgery
6/0 Face, blood vessels
5/0 Face, neck, blood vessels
4/0 Mucosa, neck, hands, limbs, tendons, blood vessels
3.0 Limbs, trunk, gut, blood vessels
2/0 Trunk, fascia, viscera, blood vessels
0 and larger Abdominal wall closure, fascia, drain sites, arterial lines,
orthopaedic surgery

DESIGN

Sutures are designed to meet many different needs [45]. Sutures for
abdominal surgery, for example, are different from sutures used in
cataract surgery. Since no one type of suture is ideal for every operation,
surgeons and medical designers have come up with sutures with varying
qualities. One may be more absorbable but less flexible, while another
may be exceedingly strong but perhaps somewhat difficult to knot. This
gives surgeons many options. Designers of a new suture have to take
into account many factors. The rate at which the suture degrades is
important, not only along the length of the suture but at the knot also.
Some sutures need to be elastic, so that they will stretch and not break.
Others need to hold tight. Suture manufacturers use specially designed
machines to test and study sutures. New suture designs are also tested

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Absorbable Polymeric Surgical Sutures 303

by subjecting them to chemical tests, such as soaking them in various


solutions, and testing on animals.
The surface of a monofilament is very smooth and passes easily
through tissue. However, they can be difficult to handle and tie as they
are less flexible than multifilament construction. Most monofilaments
also have ‘‘memory’’. This memory results in a suture that holds the
shape it had in the package, making it more difficult to work with. Some
memory can be relaxed, but is not effective in all sutures. In
multifilaments, construction involves several filaments or strands
being braided or twisted together. This results in a strong suture that
is flexible and easy to handle. Multifilament sutures pass less easily
through tissue than smooth monofilaments and the resulting ‘‘tissue
drag’’ can cause tissue trauma [45]. These problems are significantly
reduced by using ‘‘coated’’ braided materials.

COATING MATERIALS

Suture materials are frequently coated, especially braided or twisted


sutures, to facilitate their handling properties, particularly a reduction
in tissue drag when passing through the needle tract and the ease of
sliding knots down the suture during knotting. Traditional coating
materials used are bees wax, paraffin wax, silicone, poly(tetrafluor-
oethylene) (PTFE), etc. The trend is toward a coating material that has
a chemical property similar to the suture to be used. The coatings
used depend on whether the suture is absorbable or nonabsorbable.
Absorbable coatings include Poloxamer 188 and calcium stearate
with a copolymer of glycolic acid (GA) and lactic acid (LA)
[55]. Nonabsorbable sutures may be coated with wax, silicone,
fluorocarbon, etc.
Sutures may also be dyed to make them easy to see during surgery.
Only FDA-approved dyes and coatings may be used. Some allowable dyes
are: logwood extract, chromium–cobalt–aluminum oxide, ferric ammo-
nium citrate, pyrogallol, D&C Blue No. 9, D&C Blue No. 6, D&C Green
No. 5, and D&C Green No. 6. Suture needles are made of stainless or
carbon steel. The needles may be nickel-plated or electroplated.
Packaging material includes water-resistant foil, such as aluminum
foil as well as cardboard and plastic.

THE PROCESS OF WOUND HEALING

The implantation of biomaterials initiates both an inflammatory


reaction to injury as well as processes to induce healing [56–58].

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304 C. K. S. PILLAI AND C. P. SHARMA

The healing of wounds is a complex dynamic process that can be


separated into a series of phases. Phase I of wound healing involves an
inflammatory response over 1–5 days that induces an outpouring of
tissue fluids into the wound, an increased blood supply and cellular and
fibroblast proliferation. In Phase II of wound healing, covering a period
of 5–14 days, there is an increased collagen formation and deposition
within the wound, together with formation of fibrin and fibronectin
through fibroblastic activity, and wound closure/contraction com-
mences. Phase II gradually merges to Phase III, from day 14 onward,
and there is reorganization and maturation (cross-linking) of collagen
fibers together with deposition of fibrous connective tissue, the latter
resulting in scar formation. This healing process occurs when there is no
infection, minimal edema (swelling), or fluid discharge. Complications in
would healing and their attendant delays commonly result from two
primary causes, infection and mechanical effects [59].

ABSORBABLE NATURAL SUTURE MATERIALS

Sutures are, in general made up of fibers from natural or synthetic


polymers. Metallic fibers such as steel fibers are also used extensively.
Polymeric fibers could be absorbable or nonabsorbable. Natural sutures
are made of catgut or reconstituted collagen (RC), or from cotton, silk, or
linen. Synthetic nonabsorbable sutures may be made of PP,
poly(ethylene glycol terephthalate) (PET), poly(butylene glycol terephtha-
late) (PBT), polyamide (PA), different proprietary Nylons, or GoretexÕ .
Catgut and regenerated collagen are the two absorbable natural
sutures available in the market. The term ‘catgut’ was first mentioned
in 1599, in J.A. Murray’s English Dictionary, where ‘kit’ or ‘cat’ was not
listed as describing the animal, cat, but ‘violin, stringed instruments
collectively.’ Consequently, ‘catgut’ meaning something like ‘lute string’
has arisen through a mistaken inference that ‘kit’ referred to ‘cat’ [60].
Another view is based on its source. Catgut is prepared from the
intestines of the sheep or goat, or in general from ‘cattle’ which
originally denoted not only cows but all types of livestock. So, the ‘cat-’in
‘‘catgut’’ might not refer to cat, but it is an abbreviation for ‘cattle.’
Catgut was the staple absorbable suture material through the 1930s,
while physicians used silk and cotton where a nonabsorbable material
was needed. Catgut sutures are well known for their great toughness
and tenacity. Catgut is sold as plain catgut (untreated) and CG (tanned
by chromium trioxide, the yellow shade of plain catgut then turn to a
darker shade of brown). The chromium trioxide treatment, first
developed by Joseph Lister, makes CG more resistant to absorption

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Absorbable Polymeric Surgical Sutures 305

and causes less tissue reaction than plain catgut suture [61]. Its uniform
chromic properties allow a slow and safe absorption with minimal tissue
reaction.
The basic constituent of catgut is collagen, which is the main
constituent of skin and hides and is used as source of gelatin and glue
and leather. Collagen is the major structural protein found in all
multicellular organisms.
Catgut sutures are packaged in alcohol solution like ethanol or
isopropanol to retain their flexibility and packages are sterilized either
by 60Co g-ray irradiation or ethylene oxide (EO) treatment. Glycerine
coating (SoftgutÕ ) is adopted to eliminate the need of alcohol packing.
The coating also improves handling characteristics. However, some
complications have been reported on its use [62,63].

Degradation Behavior of Absorbable Natural Suture Materials

Typically, sutures made from catgut are readily absorbed by the


human body mainly due to the actions of the proteolytic enzymes of
phagocytes and other cells [64–66]. Cellular collagenase and proteases
eventually degrade and remove catgut and reconstituted collaged base
sutures giving rise to a rapid loss of strength during the most critical
period of wound healing and higher than average level of tissue
reactions [64–68]. Catgut sutures retain tensile strength during the
first 4–5 days only and after 2 weeks, the tensile strength is essentially
gone [22]. On the other hand, in a comparative study of PDO, PGA
(DexonÕ ), Polyglactin 910 (VicrylÕ Rapid, an irradiated form of VicrylÕ
to increase the rate of hydrolysis), and CG suture materials for closure
of skin incision in rats, Aslan et al. [69] showed that the macroscopic
appearance of all specimens was not statistically different. CG,
however, retains strength for 2–3 weeks. Fast-absorbing gut
(Ethicon) is the newer form that dissolves fast and can be used in
children. Catgut sutures elicit far more intense tissue reaction than
synthetic absorbable sutures, because of their foreign protein struc-
tures. Areas of catgut suture degradation contain dense accumulation
of macrophages, lymphocytes, and foreign body giant cells. After
complete absorption, these are replaced by a dense mass of
macrophages [70]. The tissue reactions are far more intense with
plain catgut sutures giving rise to exudates with some tissue necrosis
[71]. Most studies indicate that catgut sutures are completely absorbed
between 35 and 60 days [70,72].
Postlethwait and Smith [73] used a new synthetic suture, XLGÕ
which is a copolymer derived from LA and GA through lactide (LL) and

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306 C. K. S. PILLAI AND C. P. SHARMA

glycolide (GL) intermediates. Determinations of the rate of loss of


strength in various sites in experiments on dogs show that XLGÕ loses
strength slightly more rapidly than does CG. An exception is sutures
suspended in the stomach, where CG quickly loses strength, whereas
XLGÕ maintained strength similar to that at other implantation sites
[73]. In a comparative study with VicrylÕ suture, Reul Jr. concluded
(after a study in 53 patients subjected to a wide range of general
abdominal and cardiovascular procedures) that VicrylÕ suture may be
used wherever catgut or other absorbable sutures are normally used and
has the advantage of greater reliability of strength retention and rate of
absorption than is observed with CG [74]. Sanz et al. [75] report after a
comparative study of standard absorbable sutures, that MaxonÕ and
PDS elicited a lower degree of chronic inflammation when compared
with VicrylÕ and CG. In developing a standardized readily reproducible
experimental model, Edlich et al. [76] showed that among the
absorbable sutures, DexonÕ sutures evoked the least inflammatory
response and that the infection rate of contaminated tissues containing
DexonÕ was significantly lower than the incidence of infection of tissue
containing catgut sutures. Similar studies on comparative evaluations of
various fibers have shown that that the catguts cause more intense
tissue reaction than the other fibers [77,78].
Shishatskaya et al. [79] implanted polyhydroxyalkanoate (PHA)
sutures [polyhydroxybutyrate (PHB) and a copolymer of hydroxybuty-
rate and hydroxyvalerate (PHV)] to test animals intramuscularly, and
tissue reaction was investigated and compared with the reaction to silk
and catgut. The reaction of tissues to the polymeric implants was similar
to their reaction to silk and was less pronounced than the reaction to
catgut.
Sharp et al. [80] addressed the problem of common bile duct strictures
by systematically investigating the healing canine end-to-end choledo-
chal anastomosis sutured with monofilament polyglyconate (PG)
absorbable suture and comparing with braided VicrylÕ and CG sutures.
Seventy-six canines, randomized to control versus sutured groups,
underwent either mobilization (controls) or transection of the mid-
common bile duct and were allowed to heal 5, 10, 15, or 50 days post-
operatively before sacrifice. PG suture caused significantly less
perianastomotic inflammation than did chronic suture, with VicrylÕ
sutures evoking an intermediate inflammatory response.
In a study involving the comparative evaluation of the effects of CG,
VicrylÕ , PDO, and PTMC suture on urothelial healing in a rabbit model
simulating pyeloplasty, Wainstein et al. [81] performed pyelouretero-
tomies on 8-week-old rabbits (12 rabbits (24 renal units) and 3 control

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Absorbable Polymeric Surgical Sutures 307

rabbits) and closed with interrupted 7-0 sutures. Histologic evidence of


acute and chronic inflammation and foreign body reaction was most
severe at 10 days and 5 weeks in pyeloureterotomies closed with CG.
There was mild inflammation in those closed with VicrylÕ at 10 days,
but it was minimal in those closed with VicrylÕ , PDO, and PTMC at
5 and 12 weeks. Reabsorption of PGA was complete by 5 weeks, but was
incomplete with the other three sutures at that time. By 12 weeks, there
was persistent suture in 50% of the renal units closed with PDO and in
100% of those closed with PTMC. No animal developed a renal calculus.
Because of the mild inflammatory response and rapid tissue reabsorp-
tion of VicrylÕ in this animal model, this suture appears to be the best
suture for pyeloplasty.
In another study involving a comparative evaluation of plain catgut
and CG with DexonÕ , Dexon PlusÕ , and MaxonTM (incubated in
human gastric juice, bile, pancreatic juice, and their mixture), Tian
et al. [82] reported that plain catgut rapidly lost its strength in each of
these digestive fluids. CG was susceptible to digestion although it
retained most of its strength in bile for 2 weeks. Synthetic absorbable
sutures, PGA or its derivatives (DexonÕ , Dexon PlusÕ , and MaxonTM),
maintained most of their strength for 2 weeks, disintegrating only
after 5–8 weeks. Although catgut is widely used, the study suggests
that it disintegrates too rapidly, at least under the conditions tested, to
be appropriate for alimentary tract surgery, whereas the synthetic
sutures maintained their integrity rather well for 2–3 weeks needed for
visceral wound healing. The data suggest that slowly absorbed
synthetic sutures may be particularly useful in pancreatic or biliary
anastomoses where a single layer is preferable and where a
nonabsorbable suture offers inherent disadvantages. A similar com-
parative study between the copolymer, poly(lactide-co-glycolide)
(PLGA) and CG in corneal surgery by Dunlap et al. [83] showed that
the 8/0 copolymer showed 30% greater initial strength than 8/0
chromic collagen. At the end of 1 week, the copolymer retained over
90% of its initial rupture strength while chromic collagen had lost
nearly 50% of its strength. After 10 days, the strength of the copolymer
tended to fall rapidly and by day 21 the suture had negligible strength
and began to absorb, completely disappearing by 7 weeks. Chromic
collagen tended to remain in situ for many weeks although possessing
negligible rupture strength. These sutures were used in suturing
corneoscleral wounds of 45 consecutive patients undergoing routine
cataract surgery.
Comparing suture strengths for clinical applications, Vasanthan et al.
[84] evaluated three suture materials CG, VicrylÕ , and VicrylÕ fast

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308 C. K. S. PILLAI AND C. P. SHARMA

absorbing (VicrylÕ Rapid) in 4-0 and 5-0 gages. The authors found that
that CG sutures could sustain their strength better than VicrylÕ Rapid
after 2 weeks. The 4-0 sutures are stronger and have greater tensile
strength than 5-0 sutures. VicrylÕ Rapid may not be a desirable suture if
tensile strength is required after 10 days. Appropriately designed clinical
studies are necessary to confirm this finding in an in vivo environment.
Table 7 provides a comparative evaluation of natural absorbable sutures
with those of natural nonabsorbable sutures [22,69,70,72,75,82–84].
CG is suitable for all surgical procedures, especially for tissues that
regenerate faster. It is not generally recommended for an incision that
requires sustaining of the tissues for a prolonged period of time. It is
absorbed much faster when used in the mouth and in the vagina, due to
the presence of microorganisms. Special precautions should be taken for
cardiovascular surgery, due to the continued heart contractions. Special
precautions should also be taken in patients with cancer, anemia, and
malnutrition conditions. They tend to absorb this suture at a higher
rate. Although synthetic alternatives are available, catgut sutures are
still used in hospitals throughout the world [84].

Reconstituted Collagen

RC, having been shown previously to be biodegradable and to have low


immunologic activity, is prepared either by enzymatic digestion of native
collagen-rich tissues or by the extraction of the tissues with salt

Table 7. Chemical and physical properties of PGA [1,5,9,11,15,16,18,85,86].


Melting temperature 224–2268C, 215–2178C
Glass transition temperature 368C
Density 1.5–1.64 g/cm3
Specific volume (1/density) 0.5952 cm3/g
Specific gravity (100% crystalline) 1.548
Specific gravity (100% amorphous) 1.707
Specific gravity (100% crystalline) 1.50
Heat of fusion (100% crystalline) 49.34 cal/g
Crystallinity (%) 35–37
Solvent Hexafluoroisopropanol (HFIP)
Molecular weight 20–145,000
Inherent viscosity 0.5–0.6 dL/g
Intrinsic viscosity 0.6–1.6 dL/g
Diameter 15–25 mm
Tenacity 5–10 g/denier
100–200,000 psi
Knot/straight tenacity 50–80%
Elongation 15–35%

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Absorbable Polymeric Surgical Sutures 309

solutions. RC sutures prepared from bovine long flexor tendons are


similar in appearance to catgut and are almost exclusively used in
microsurgery. The mechanical and thermal stability of RC fibrils can be
increased by maturation in vitro when incubated in air at 378C [87–89].
RC sutures are used in ophthalmic surgery as well as for other
applications [90–92]. Plain collagen (PC) sutures were, however,
shown to act as relatively inert bodies when used to close experimental
cataract incisions [93]. In a study on tissue reactions produced by these
sutures, Regan and Dunnington showed that in cataract incisions the
absorption of these sutures did not occur until wound healing was well
established. They concluded that collagen appeared to be a satisfactory
suture material for ocular surgery [93].

ABSORBABLE SYNTHETIC SUTURE MATERIALS

Following the successful development of the synthetic absorbable


polymer, PGA in the early 1970s, a series of polymers and copolymers
based on a few cyclic lactones (Figure 1) were synthesized, character-
ized, and produced commercially. Schemes 1–6 provide the structures of
the currently marketed polymers and copolymers. Thus, several new

O O
CH3 O O

O O O O CH3

Glycolide Lactide

O O O O

O
p-Dioxanone Caprolactone

O O

O
Trimethylene carbonate

Figure 1. Lactone monomers used in preparing suture materials.

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310 C. K. S. PILLAI AND C. P. SHARMA

O O
Catalyst
O heat
O CH2 C O CH2 C
O
n

O
Glycolide Polyglycolide

Scheme 1. Polymerization of glycolide.

O
O
O
HO
OH O

Lactic acid O
Lactide

Ring opening Polymerization

O
O
( (
n

Polylactide (PLA)

Scheme 2. The ring opening polymerization of the cyclic diester of lactic acid, lactide.

O O
O
O O Sn(Oct)
2 O
O O O
m n
O
O O

Scheme 3. Synthesis of PLGA.

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Absorbable Polymeric Surgical Sutures 311

O O
O O

+ O O
O

TMC Glycolide

O O O

OCH2 C OCH2CH2CH2O C OCH2 C

X Y Z
‘MAXON’

Scheme 4. Synthesis of block co-polymers of TMC and glycolide.

O O
O O

+ O O

Caprolactone Glycolide

O O O

OCH2C OCH2CH2CH2CH2CH2 C OCH2C


X Y Z

‘MONOCRYL’

Scheme 5. Synthesis of copolymer of e-caprolactone and glycolide.

synthetic absorbable suture materials such as DexonÕ (Davis & Geck


Corp), VicrylÕ (Ethicon), PDO (Ethicon), PDOIIÕ (Ethicon), MaxonÕ
(Davis & Geck), MonocrylÕ (Ethicon), and BiosynÕ (US Surgical,
Norwalk, CT; Table 3) have been commercially made available.
New sutures are being developed all the time, to respond better to

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312 C. K. S. PILLAI AND C. P. SHARMA

O O O O
O O

O + O + O O

PDO TMC Glycolide

O O
O

OCH 2 C OCH2 CH2 CH2O C


OCH2 CH2 OCH2 C
Z X Y
‘BIOSYN’

Scheme 6. Synthesis of terpolymer composed of glycolide, TMC, and dioxane.

particular surgical needs. The spectrum of suture material properties


is researched through laboratory experiments, whose results are
validated in extensive studies and trials [15,94]. Absorbable
sutures are now well known to behave favorably in vitro and in an
animal model [95].
Owing to their precisely controlled manufacturing processes and
uniform and reproducible properties, these absorbable biomaterials have
received a great deal of attention in the medical field [1,85]. The most
important advantage of synthetic absorbable sutures is their reprodu-
cible degradability inside a biological environment. This property will
enable the sutures to minimize chronic undesirable tissue reactions
after the sutures have lost their function. Due to the development of
these synthetic fibers, they have replaced some natural fibers like
cotton, linen, and catgut for wound closure purposes. Today, surgeons
have the option to choose among a large number of suture materials
(Tables 3 and 4) with various chemical, physical, mechanical, and
biological properties.
VicrylÕ is a braided suture produced from a copolymer of GA/LA at a
90/10 mol/mol composition [96,97]. PolisorbÕ and XLGÕ are based upon
a combination of GA and LA but with a different composition. DexonÕ
[96,97] is a braided suture based upon the homopolymer of GA.
MaxonÕ [98], the most pliable monofilament suture to date, is formed
from a segmented block copolymer of GL and e-caprolactone
(e-CL). Recently, BiosynÕ [99], a monofilament suture based on a

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Absorbable Polymeric Surgical Sutures 313

nonrandom terpolymer of p-dioxanone, trimethylene carbonate (TMC)


and GA, was introduced. A modified version of the suture, VicrylÕ
Rapid, is currently on the market, which is an irradiated version of the
suture to increase the rate of degradation. PanacrylÕ is another
commercially developed suture from the copolymer with a higher LA/
GA ratio in order to decrease the rate of degradation. Several
copolymers have subsequently been developed for the fabrication of
monofilament sutures [100–103].
The general criteria for selecting a polymer for use as a suture are to
match the mechanical properties and the time of degradation to the
needs of the application [104–116]. Claude et al. [117] compared the
performance of nonabsorbable sutures, commonly used for vascular
anastamoses in microsurgery, with absorbable sutures, rarely evaluated
in this type of surgery. The reported results from macroscopic,
histologic, and functional evaluations revealed no significant differ-
ences between the two types of sutures. However, local giant-cell
inflammatory reaction was more important with the nonabsorbable
suture. The use of nonabsorbable sutures such as PP usually causes
late-occurring wound sinus formation in mass closure of midline
incisions in general surgery and gynecology patients with a reported
small incidence of fascial dehiscence. Gallup et al. [118] showed that
the closure technique is safe and expedient and distributes tension
equally over a continuous line with PGA filaments. Yang and Pastorino
[119] state that monofilament absorbable sutures are at least as good
as steel wires to close the sternum after complete or partial sternotomy.
In a study carried by Andrade et al. [120] on evaluating the suture
material modifications resulting from its interaction with tissues, it
was observed that absorbable suture materials induced differentiated
tissue reactions and morphologic surface changes suggesting that
indications should be individualized. A comparison of absorbable versus
nonabsorbable sutures was done by Tan et al. for subcuticular skin
closure of a transverse suprapubic incision [121]. Ferguson et al. [122]
noted that saliva appears to enhance degradation rates in both
synthetic and natural absorbable sutures. Riddick et al. [123] evaluated
the effect of absorbable sutures in reproductive tissue and concluded
that (1) the magnitude of tissue response to suture material varies for
different tissues, (2) the degree of tissue wall fibrosis does not
necessarily correspond to external tissue adhesions, and (3) adhesions
are maximal at the surgical knots regardless of the suture material
used. De Persia et al. [100] may be referred for obtaining data on
comparative evaluation of properties and performance of a number of
sutures.

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314 C. K. S. PILLAI AND C. P. SHARMA

Polyglycolide or Poly(Glycolic Acid) (PGA)

Poly( -ester)s are thermoplastic polymers with hydrolytically labile


aliphatic ester linkages in their backbone. Although all polyesters are
theoretically degradable, only aliphatic polyesters with reasonably short
aliphatic chains between ester bonds can degrade over the time frame
required for suture materials [124]. PGA is the simplest linear aliphatic
polyester. Owing to its controllable hydrolytic degradation, PGA and its
copolymers with LA, e-CL, and TMC are widely used as materials for the
synthesis of absorbable sutures and are being evaluated in the
biomedical field [104,108,112].

Synthesis and Properties of PGA

PGA can be obtained through several different processes starting with


different materials: polycondensation of GA, ring-opening polymeriza-
tion (ROP) of GL (Scheme 1), solid-state polycondensation (SSP) of
halogenoacetates, acid catalyzed reaction of carbon monoxide, formal-
dehyde, etc. The ROP of GL obtained by heating GA is the most common
synthetic method adopted to produce the high molecular weight (MW)
product. Stannous octoate, approved by the FDA as a food stabilizer,
is the most commonly used initiator [86,125,126]. PGA of MW
20,000–140,000 is suitable for fiber extrusion and suture manufacturing.
Tables 7 and 8 list the properties of the polymer and its fiber.
SSP is employed in another procedure where sodium chloroacetate is
heated at a temperature between 1608C and 1808C, continuously passing
nitrogen through the reaction vessel. The sodium chloride which
precipitates within the polymeric matrix can be conveniently removed
by washing the product of the reaction with water [128]. In another
method, the acid catalyzed reaction of carbon monoxide, formaldehyde,
or one of its related compounds like paraformaldehyde or trioxane is
employed to prepare PGA [129].
PGA is a highly crystalline (around 45–55%) polymer having glass
transition temperature between 358C and 408C and its melting point in
the range 225–2308C (Tables 7 and 8). It is soluble only in highly
fluorinated solvents like hexafluoroisopropanol and hexafluoroacetone
sesquihydrate that can be used to prepare solutions of the high MW
polymer for melt spinning and film preparation. Fibers of PGA exhibit
high strength and modulus. PGA shows excellent mechanical properties
due to its high crystallinity. A self-reinforced form composed of PGA is
stiffer than any other degradable polymeric system used clinically [24]

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Absorbable Polymeric Surgical Sutures 315

Table 8. The absorption times of some absorbable suture materials. Reproduced


from ref. [127] with permission from Elsevier Inc.

Commercial Absorption
Suture material Type name Tensile strength loss time (days)
Plain catgut Natural fiber Plain catgut
Variable up to 7 days, 70
as long as 10 days
TM
Polyglytone Monofilament Caprosyn 50–60% at 5 days, 56
20–30% at 10 days
Chromic catgut Natural fiber Chromic catgut Variable up to 14 days, More than 90
as long as 21 days
TM
Polyglactin 910 Braided Vicryl 75% at 14 days, 50% 56–70
at 21 days
TM
Glycomer 631 Monofilament Biosyn 75% at 14 days, 40% 90–110
at 21 days
TM
Poliglecaprone Monofilament Monocryl 50–70% at 7 days, 91–119
20–40% at 14 days
TM
Polyglycolic acid Braided Dexon 60% at 7 days, 90–120
20% at 15 days
TM
Polyglycolic acid Monofilament Maxon 75% at 14 days, 120–180
65% at 21 days
Polydioxanone Monofilament PDS IIÕ More than 85% at 120–180
14 days, 60% at 28 days

and has been shown to exhibit a modulus of approximately 12.5 GPa


[25].
Due to its excellent fiber-forming ability and biodegradability, PGA
was investigated for developing resorbable sutures [130]. This resulted
in the development of DexonÕ series of commercial sutures. [DexonÕ
was the first FDA approved (1969) synthetic suture.] Among the DexonÕ
series of commercial PGAs, DexonÕ S is uncoated and DexonÕ Plus and
DexonÕ II are coated to improve handling properties, knot performance,
and smooth passage through tissues. After Dexon, several grades have
appeared in the market under different trade names [131]. CaprosynÕ
suture is one of the latest innovations in the monofilament synthetic
suture market. This suture, which is reported to be adequate for
hypospadias surgery in small children [132], is a synthetic polyester
composed of GL, e-CL, TMC, and LL [127]. The absorption times of
some absorbable suture materials are compared in Table 8
[1,5,9,11,15,16,18,85,86].

Biodegradation and Biocompatibility of PGA


Aliphatic polyesters are biodegradable polymers because of the
presence of the highly hydrophilic carbonyl in the ester linkage which

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316 C. K. S. PILLAI AND C. P. SHARMA

undergoes hydrolytic and/or enzymatic chain cleavage to -hydroxy-


acids, which in most cases are ultimately metabolized in human body.
The parameters that control the hydrolysis rates are the temperature,
molecular structure, and ester group density as well as the species of
enzyme used. The degree of crystallinity may be a crucial factor, since
enzymes attack mainly the amorphous domains of a polymer [133].
PGA undergoes hydrolytic degradation through the nonspecific
scission of the ester backbone [85]. The degradation process is erosive
and appears to take place in several steps during which the polymer is
converted back to its monomer GA: the first step involves diffusion of
water into the amorphous (noncrystalline) regions of the polymer
matrix, cleaving the ester bonds; the second step starts after the
amorphous regions have been eroded, leaving the crystalline portion of
the polymer susceptible to hydrolytic attack. Upon collapse of the
crystalline regions, the polymer chain dissolves.
When exposed to physiological conditions, PGA is also broken down by
certain enzymes, especially those with esterase activity [112,134–138].
The degradation product, GA, is nontoxic and it can enter the
tricarboxylic acid cycle after which it is excreted as water and carbon
dioxide. A part of the GA is also excreted by urine [112,134]. Studies
carried out using sutures made from PGA have shown that the material
loses half of its strength after 2 weeks and 100% after 4 weeks. The
polymer is completely resorbed by the organism in a timeframe of 4–6
months [105,108]. Figure 2 shows the in vitro degradation of PGA.
The absorption of water and its penetration into the interior of PGA,
PLA, and their copolymers initiate hydrolytic fragmentation degrada-
tion followed by the reduction of mechanical properties [139,140]. The
degradation of PGA is faster than that of PLA. Unlike PLA,
extracellular enzymes are also thought to have a role in in vivo
degradation of PGA. The glycolate generated from PGA during final
hydrolysis is either excreted directly in the urine or is oxidized to
glyoxylate that gets converted to glycine, serine, and pyruvate [141].
Debus et al. [131] studied four different braided absorbable surgical
materials (DexonÕ , Dexon II BicolorÕ , VicrylÕ , and PolysorbÕ ) in vitro
and in vivo with regard to their physical properties as well as tissue
compatibility and surgical handling and found that they basically share
the same indications. The authors concluded that all features and
properties of braided suture material reached a high level of quality with
PolysorbÕ .
The tensile tests on co/terpolymers of LL, e-CL, and GL showed that
the tensile strength was strongly dependent on the draw ratio [142].
Tissue reaction to suture materials depends mainly on how the polymer

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Absorbable Polymeric Surgical Sutures 317
120

100

80
% Retained strength

60

40

20

0
0 1 2 3 4 5 6 7
Weeks

Figure 2. In vitro degradation of polyglycolide: Retained tensile strength vs time.


(Reproduced from ref. [138] with permission from Wiley InterScience.)

they are composed of interacts with the tissues. Deng et al. [143] showed
that there was strong interrelationship among material properties,
in vitro time and experimental conditions. In a study involving rat
subcutaneous tissue reaction to irradiated VicrylÕ Rapid, PDO,
MonocrylÕ , and CG, Andrade et al. [120] observe that tissue reaction
to suture materials depends mainly on how the polymer they are
composed of interacts with the tissues. They observed that VicrylÕ Rapid
lost all its strength within 14 days. PanacrylÕ is another commercially
developed suture from the copolymer with a higher LA/GA ratio in order
to decrease the rate of degradation.
Pineros-Fernandez et al. [132] made a comparative evaluation of
CaprosynÕ suture and CG suture. The rate of loss of suture mass of
these two sutures was similar. As expected, CG sutures potentiated
significantly more infection than did the CaprosynÕ sutures. The
handling properties of the CaprosynÕ sutures were far superior to
those of the CG sutures. The smooth surface of the CaprosynÕ
sutures encountered lower drag forces than did the CG sutures.
Furthermore, it was much easier to reposition the CaprosynÕ knotted

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318 C. K. S. PILLAI AND C. P. SHARMA

sutures than the knotted CG sutures. These biomechanical perfor-


mance studies demonstrated the superior performance of synthetic
CaprosynÕ sutures compared to CG sutures and provide compelling
evidence of why CaprosynÕ suture is an excellent alternative to CG
suture.
Hong et al. [144,145] compared the biodegradability of MonocrylÕ
monofilaments with poly(trimethylene carbonate-e-caprolactone)-block-
poly(p-dioxanone) [poly(TMC-e-CL)-block-PDO] copolymers. The biode-
gradability of PDO homopolymer is much slower compared with that of
the copolymer, MonocrylÕ . The lower rate of degradation of MonocrylÕ
may be due to the presence of the GL content in it. The release of an
antimicrobial agent like triclosan added to the surface of PGA threads
was studied by Zurita et al. [146] in different media with high-
performance liquid chromatography.
The efficacy of five synthetic absorbable suture materials in intestinal
anastomoses in rats, together with their interference with the normal
physiopathological cicatrization process was investigated by de Werra
et al. [147]. The materials analyzed were PGA, DexonÕ , MaxonÕ , PDO,
VicrylÕ , and BiosynÕ . An anatomopathological study, performed in three
groups of rats undergoing postmortem examinations after 6, 20, and 90
days showed that the least interference was caused by BiosynÕ , while
PGA and VicrylÕ yielded very good results though giving rise to a
greater fibrous component [147]. In another comparative study, Aslan
et al. [69] did not find any difference in the macroscopic appearance of
all specimens of the histopathological cross-sections from the skin
incision sites under light microscope. A prospective, randomized trial
compared PGA subcuticular skin closure with interrupted silk skin
closure in 152 patients [148]. There was no significant difference in the
incidence of wound infection.
Absorbable monofilaments, such as the monofilament sutures such as
PDOÕ II and MaxonÕ eliminate many of the concerns raised by braided
sutures, but generally monofilaments do not handle as well as braids.
These sutures provide an in vivo breaking strength retention of
approximately 20–30% after 2 weeks, considered by many to be the
critical wound healing period [149]. Monofilament sutures of block
terpolymers of LL, e-CL, and GL also showed potential for use as
absorbable surgical sutures [150]. In another study on MonocrylÕ , silk,
and VicrylÕ sutures in oral surgery, Arcuri et al. [151] noted that the
clinical healing at 90 days was the same for all the different threads,
different from what happened in the critical post-operative period
(within 3 weeks). Moy and Kaufman studied 584 repairs of surgical
defects using two different synthetic absorbable sutures, VicrylÕ , and

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Absorbable Polymeric Surgical Sutures 319

MaxonÕ . No difference in scar width or post-operative complications was


found between the two sutures, but MaxonÕ demonstrated preferable
handling and tying characteristics [152].
Several authors [153–155] studied the effect of coatings such as
poloxamer 188 on the handling characteristics of synthetic sutures.
Poloxamer 188 was chosen because it does not damage the tissue
defenses of the host and invite infection. Since poloxamer 188 is readily
soluble in aqueous solutions, it is rapidly absorbed in the tissue
environment resulting in an uncoated suture that displays increased
knot security. The increased knot security, thus, observed with the
coated PGA suture after implantation, was considered to be a distinct
clinical advantage over that of the coated VicrylÕ Rapid sutures [153]. In
another study, uncoated Dexon-SÕ was found to be superior to coated
VicrylÕ with respect to knot reliability [154]. DexonÕ was reported to
offer a favorable alternative for catgut since this synthetic absorbable
suture material produced fewer early tissue reactions in a study on 123
patients undergoing neck surgery with respect to wound complications
[155]. DexonÕ appears to offer a favorable alternative since this
synthetic, absorbable suture material produces fewer early tissue
reactions.
Edlich et al. [156] showed that the chemical structure of the suture
appeared to be the most important factor in the development of surgical
infection and PGA sutures were found to evoke the least inflammatory
response among the absorbable sutures. After evaluating the use of PGA
sutures in 126 operations performed upon 118 unselected patients,
Dardik et al. [157] reported that PGA exhibited excellent behavior so
that it could be termed a ‘‘universal’’ suture material. PGA appears to
compare favorably with other sutures with respect to handling, tensile
strength, knot security, lack of toxicity, and minimal tissue reaction.
PGA did not interfere with the process of wound healing, and the
material was well tolerated in both clean and contaminated operations.
Similar results are reported by other groups as well [158–160]. The use
of absorbable sutures such as DexonÕ in corneolimbal incision technique
was reported to be seemingly safe [161].
The VicrylÕ suture was assessed in 72 surgical patients who
underwent follow-up observation for at least 30 days, and it proved to
be an excellent inert absorbable synthetic suture [162]. In order to
rapidly assess the performance of a suture material, Weir and Buchanan
showed that increasing the test temperature may be an effective method
for accelerating the degradation rate of bioabsorbable polymers as a
potential means to rapidly assess processing, sterilization, and storage
variables [163].

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320 C. K. S. PILLAI AND C. P. SHARMA

Liu et al. [164] compared VicrylÕ , PP, and VicrylÕ Plus fibrin glue
sutures in the closure of pharyngeal wounds in experimental animals.
There was a significant difference in the rates of pharyngo-cutaneous
fistula formation between rats having VicrylÕ and PP sutures. The
fibrin glue-treated group had the highest fibroblast activity and collagen
deposition. PP produced minimal tissue reaction, which facilitated the
healing process.
Sutures are generally sterilized by EO. However, it was shown by
Bezwada et al. [165] that PGA braided sutures could be sterilized
without damage by Gama radiation.
PGA is particularly useful in subcutaneous and intracutaneous
closures, abdominal, and thoracic surgeries. With its high initial tensile
strength, it has guaranteed holding power through the critical wound
healing period. This suture being absorbable should not be used where
extended approximation of tissue is required. Special precautions
should be taken in elderly patients and patients with history of anemia
and malnutrition conditions. As with any suture material, adequate
knot security requires the accepted surgical technique of flat and
square ties.

Polylactide or Poly(Lactic Acid) (PLA)

PLA polymers are leading biomaterials having applications in


biomedical and pharmaceutical industries as resorbable implant
materials, wound closure, bone fixation devices and as vehicles for
controlled drug delivery [166–168]. They are characterized by their
inherent biodegradability and biocompatibility with high mechanical
strength. However, their clinical applications are sometimes affected by
the high hydrophobic behavior and consequent poor water uptake,
which results in a slow hydrolytic degradation rate [169].
Copolymerization of LL with other comonomers is used to modify the
properties of PLA and to control its degradation behavior suitable for
the specific applications in the field [170–173].
The synthesis of PLAs can be carried out by the ring opening
polymerization of the cyclic diester (LL) of LA (Scheme 2) [174–176].
PLA of high MW for suture applications is produced from the LL
monomer by ROP using most commonly a stannous octoate catalyst
[174]. Due to the chiral nature of LA, several distinct forms of
polylactide exist: poly-L-lactide (PLLA or PLA in common use) is the
product resulting from polymerization of L-lactide. Polymerization of a
racemic mixture of LL and D-lactides (DL) usually leads to the synthesis

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Absorbable Polymeric Surgical Sutures 321

of poly-DL-lactide (PDLLA) which is not crystalline but amorphous.


It is reported that the PLA produced using silica-supported alkoxide
catalysts had a higher MW weight and Tm than those produced with the
homogeneous catalyst [175]. PLA has a crystallinity of around 37%, a
glass transition temperature between 508C and 808C and a melting
temperature between 1738C and 1788C.
There are several patents that report the production of sutures from
PLA polymer [177–184]. Reinforced PLA fibers can be made by a dry-
spinning/hot-drawing process [185]. The initial tensile strength of the
PLA fibers is lower than that of the commercially available sutures such
as PDO, VicrylÕ , silk, and EthilonÕ (EthilonÕ refers to Nylon 6 and
Nylon 66 monofilament suture marketed by Ethicon). The handling
characteristics of PLA sutures were found to be superior to those of the
monofilament sutures such as PDO and EthilonÕ and comparable with
the multifilament sutures such as VicrylÕ and silk. A composite
consisting of PDLA and bioglass was used as a coating for degradable
sutures such as VicrylÕ by Chen et al. [186]. Scanning electron
microscopy (SEM) observations indicated a homogeneous coating on
the surface. The results suggest that the bioglass/PDLA/VicrylÕ
composite sutures are promising bioactive materials for wound healing
and tissue engineering applications. Histological studies on the
degradation of 14C tagged PLA polymer in vivo conducted by Kulkarni
et al. indicated that PLA was nontoxic, nontissue reactive, and
biodegradable. The degradation studies also point out that the polymer
or its degradation products are not retained in any of the vital organs of
the animals. The polymer implant, however, degrades slowly in vivo,
losing 12–14% in 3 months. Their study indicated that PLA could be a
very suitable material for sutures, vascular grafts, and other surgical
implants [176].
Kangas et al. compared the strength properties of PDLA and MaxonÕ
sutures in vitro, in the subcutis, and in the achilles tendon of rabbits and
showed that although PDLA had a lower initial tensile strength than
MaxonÕ , PDLA showed more prolonged tensile strength retention (TSR)
than MaxonÕ [187]. The authors concluded that PDLA offered an
alternative to MaxonÕ in the repair of the Achilles tendon. Lou et al.
[188] reported that when PLA sutures of size 5-0 were exposed to
physiological saline (0.9 wt% NaCl aqueous solution) at 378C, the knot-
pull strength decreased by 12% after 28 days. Figure 3 shows that
during hydrolytic degradation of PLA, molecular mass decreases and
MW distribution becomes broader continuously with an increase in the
degradation time [189]. In a comparative evaluation of mechanical
properties, Makela et al. showed that self-reinforced PLA (SR-PLA)

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322 C. K. S. PILLAI AND C. P. SHARMA

120

100

80
% Retained strength

60

40

20

0
0 10 20 30 40 50
Weeks

Figure 3. In vitro degradation of poly(L-lactide): retained tensile strength vs time


(Reproduced from ref. [138] with permission from Wiley InterScience.)

sutures exhibited the most prolonged strength retention in vitro, but the
lowest elongation (elasticity) when compared to those of MaxonÕ and
PDO sutures. When compared with straight sutures, SR-PLA knots had
lower tensile strength and elongation values [190]. They concluded that
SR-PLA sutures could be applied to the closure of wounds that need
prolonged support, such as bone. MaxonÕ sutures had lost their tensile
strength by 12 weeks and PDO sutures by 20 weeks [191–193].
Makela et al. evaluated the tissue reactions and the changes on the
mechanical properties of the PLA thread by applying it in fascial closure
of male Wistar rats [194]. Histologically, the extension of the general
inflammatory reaction and the number of the different cell types did not
markedly change during the 52-week follow-up period. The in vivo
testing of the fascial strips closed with the PLA thread retained their
resistance against the breaking force, nearly comparable to that of the
intact control fascial strips. The authors concluded that the PLA thread
was a suitable suture for wounds that require healing time of up to
28 weeks.

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Absorbable Polymeric Surgical Sutures 323

Poly(Lactide-co-Glycolide) (PLGA)

Copolymers of GL with both LL and DL have been developed for both


device and drug delivery applications. For suture applications, LL-co-GL
copolymer must have a high concentration of GL for achieving proper
mechanical and degradation properties. PLGA is synthesized by means
of random ROP of two different monomers (Scheme 3), the cyclic dimers
of GA and LA. Depending on the ratio of LL to GL used for the
polymerization, different forms of PLGA can be obtained. Multifilament
braided VicrylÕ sutures developed by Ethicon contain 90/10 molar ratio
of GA to LA and they are coated with 2–10% of a 50:50 mixture of an
amorphous polyglactin 370 (a 65/35 mole ratio of PLGA copolymer) and
calcium stearate [1]. All PLGAs are amorphous rather than crystalline
and show a glass transition temperature in the range 40–608C. Unlike
the homopolymers of LA and GA which show poor solubilities, PLGA
can be dissolved by a wide range of common solvents, including
chlorinated solvents, tetrahydrofuran, acetone, or ethyl acetate.
The copolymer PLGA has been shown to undergo bulk erosion
through hydrolysis of the ester bonds and the rate of degradation
depends on a variety of parameters including the LA/GA ratio, MW, and
the shape and structure of the matrix [195]. The degradation products
are LA and GA which under normal physiological conditions are
by-products of various metabolic pathways in the body. Since the body
effectively deals with the two monomers, there is very minimal systemic
toxicity associated with using PLGA. Miller et al. [196] have shown that
the resistance to hydrolytic degradation is found to be more pronounced
at either end of the co-polymer composition. For example, a copolymer
of 50% GL and 50% DL degrades faster than either homopolymer
(Figure 4). Copolymers of LL with 25–70% GL are amorphous due to the
disruption of the regularity of the polymer chain by the other monomer.
VicrylÕ gets absorbed within 3–4 months but has a slightly longer
strength-retention time. The biodegradability is highly related to the %
crystallinity and pH (Figure 4) [196].
Any foreign body material implanted in tissue increases the risk of
infection at that site. Wound closure always involves the use of a foreign
body. Historically, sutures have been the primary material used to close
tissue. Matičić et al. [197] point out that good tolerance and the fact that
there is no need to remove stitches make VicrylÕ Rapid suture very
interesting one used for veterinary skin surgery in wild and zoo animals,
nonsocialized pets, and wounds under casts. They noted that the
handling characteristics of ProleneÕ suture were less satisfactory than
VicrylÕ Rapid suture because of the stiffness of the material.

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324 C. K. S. PILLAI AND C. P. SHARMA

4
Month

0
0 25 50 75 100
PLA (%)

Figure 4. The effect of glycolide to lactide composition on the in vivo degradation of rate
of polygalactin implanted under the dorsal skin of rat. (Reproduced from ref. [195] with
permission from Wiley InterScience.)

Additionally, VicrylÕ Rapid showed better control of knotting than


ProleneÕ . However, it should be noted that VicrylÕ was shown to elicit
pronounced inflammatory reaction (Figure 5(a) and (c)) compared to
chiotosan gels (Figure 5(a) and (b)), which elicited very minimal
inflammatory response [198]. In the case of infectious wounds,
Piñeros-Fernandez et al. showed that the closure of contaminated
wounds with the InsorbTM staples (a copolymer of LA and GA of
unknown composition, produced by Incisive Surgical, Inc., USA) is a
superior choice to VicrylÕ suture because they have a significantly lower
incidence of infection [199]. Figure 6 gives a photograph of the
electrospun fiber of the copolymer [200].
The major popularity of these biocompatible copolymers can be
attributed in part to their approval by the FDA for use in humans, its
good processibility which enables fabrication of a variety of structures
and forms, controllable degradation rates and their success as
biodegradable sutures compared to the earlier suture materials.

Polyglyconate

Copolymers of GA with TMC have been prepared (Scheme 4) as both


sutures (MaxonÕ , by Davis and Geck) and as tacks and screws.

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Absorbable Polymeric Surgical Sutures 325

Figure 5. (a)–(c) Histological sections demonstrating minimal tissue response in the


surrounding tissues: (a) SDG implant, (100), (b) FDG implant (100), and (c) chronic
foreign body reaction in the tissues surrounding surgical sutures (200). FDG – gels with
lower cross-linking density SDG – gels with higher cross-linking density. (Reproduced
from ref. [198] with permission from Wiley InerScience.)

Figure 6. Electrospun fiber of PLGA copolymer. (Reproduced from ref. [197] with
permission from Wiley InterScience.)

Typically, these are prepared as A–B–A block copolymers in a 2:1


GL:TMC ratio, with a GL–TMC center block (B) and pure GL end blocks
(A). These materials have better flexibility than pure PGA and are
absorbed in approximately 7 months. GL has also been copolymerized
with TMC and p-dioxanone to form a terpolymer suture (BiosynÕ ) that
absorbs within 3–4 months and offers reduced stiffness compared with
pure PGA fibers [201].
Martin and Motbey [202] reported the use of MaxonÕ suture in
pediatric gastrointestinal surgery because it has a low coefficient of
friction and very low tissue drag and is stronger (straight pull and
knot strength) than corresponding gages of braided synthetic
absorbable sutures. It is slowly absorbed, its half-life (in relation

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326 C. K. S. PILLAI AND C. P. SHARMA

to strength) being 5 weeks and complete disappearance occurring


in 6–7 months. The authors report that MaxonÕ is superior to
other currently available sutures for pediatric gastrointestinal
surgery.
The hydrolytic degradation of PG has been studied in vitro by
Farrar and Gillson [203]. They report that the observed relationship
between strength and MW was more complex than expected.
However, the data could be modeled using an empirically derived
relationship between tensile strength and number average molecular
weight (Mn). Changes in other mechanical properties, such as strain
at break, were also found to be strongly dependent Mn. Flyger et al.
[204] showed that an absorbable monofilament suture such as PG
can be used safely in a single layered continuous colonic anasto-
mosis. Of the 105 patients in the study, 1 developed an anastomotic
leak. None of the patients had symptoms of anastomotic stricture at
follow-up.
The effectiveness of BiosynÕ , PDO, and MaxonÕ monofilament
sutures in healing musculoaponeurotic incisions in rats was studied by
Rodeheaver et al. The authors recommended all the three synthetic
absorbable sutures in clinical use in laparotomy incisions because they
provided secure closure of laparotomy incisions [205].
The slowly absorbing nature of PG suture was tested to determine its
suitability for use in microarterial anastomoses under ordinary tension
and under undue tension by Huang et al. [206]. The results showed that
PG suture retains tensile strength for an adequate period to allow
vascular healing and causes a less pronounced tissue response than
nonabsorbable Nylon suture. Complete absorption of the suture
material was followed by a complete regeneration of the vessel wall.
These results demonstrated that absorbable PG suture might be
suitable for microvascular anastomosis of arteries under ordinary
tension and under tension to a certain degree.

Poly(L-Lactide-co-e-Caprolactone)

The copoloymer of LL with e-CL exhibited good strength and


flexibility suitable for monofilament sutures. It also showed improved
handling characteristics. This was established by Tomihata et al. [207]
in a comparative study involving six types of other monofilament
sutures (two of these were nonabsorbable) for comparisons. Sutures
consisting of GL were the strongest among all the sutures examined. On
the other hand, ProleneÕ (PP) and poly(L-lactide-co-e-caprolactone)
(PLA-e-CL) sutures showed high knot-pull strength despite low straight

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Absorbable Polymeric Surgical Sutures 327

pull strength. A good correlation between tan  and bending plasticity


index was observed and the PLA-e-CL sutures exhibited high tan , high
bending plasticity, and good resistance against untying.
Co/terpolymers of LL, e-CL, and GL are biodegradable in the human
body and, as such, have considerable potential for use in biomedical
applications such as surgical sutures, nerve guides, bone fixation
devices, and drug delivery systems [143,208]. Baimark et al. [208]
reported that the monofilament fiber of the block copolymer of LL and
e-CL had a tensile strength 4400 MPa and recommended that this
material has potential to be developed further as a lower cost alternative
to the current commercial monofilament surgical sutures.
Monofilaments of the block terpolymer of LL, e-CL, and GL have been
melt spun for potential use as absorbable surgical sutures. As-spun
fibers of the terpolymers produced by melt spinning were elastic,
amorphous, and isotropic and could be promising materials for use as
monofilament sutures [150,209].

Polydioxanone (PDO or PDS)

Resorbable multifilament sutures such as PLA and PGA develop a


greater amount of friction when penetrating tissues and have a higher
risk of infection. So, monofilament sutures based on PDO having smooth
and soft surface were introduced in the 1980s [209]. PDO suture has
handling properties that are acceptable for use in vascular applications,
and it provides adequate mechanical support for sutured vessels to heal
[210]. In addition, PDO provides good flexibility owing to the presence of
an ether oxygen group in the backbone of the polymer chain.
PDO is prepared by the ROP of p-dioxanone to get a colorless, semi-
crystalline polymer with a very low glass transition temperature ranging
from 108C to 08C (see Table 9 for mechanical properties). Being an
aliphatic polyester, it undergoes degradation by the nonspecific scission
of the ester bond. PDO can be considered a slow to moderately degrading
polymer due to the high crystallinity and hydrophobicity of the polymer.
In the body, PDO is broken down into glycoxylate and excreted in the
urine or converted into glycine and subsequently into carbon dioxide and
water [124,211]. PDO has demonstrated no acute or toxic effects on
implantation. The monofilament loses 50% of its initial breaking
strength after 3 weeks and is absorbed within 6 months, providing an
advantage over DexonÕ or other products for slow-healing wounds.
Sutures are prepared by extrusion into fibers at the lowest possible
temperatures to avoid depolymerization back to the monomer. Several
publications exist on the synthesis [108,150,210,212], fiber formation

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328 C. K. S. PILLAI AND C. P. SHARMA

Table 9. Mean tensile properties of 2/0 size sutures that have recently become
available commercially [1,59,107,149].

Failure load (kg)


Elongation Work of Tensile
at break rupture strength
Suture Straight Knotted (%) (kg cm) (kg/cm2)
PDO II 4.4  0.2 – 5.7 18.07 –
Maxon 7.09 4.41 4.39 15.92 6056.5
Monocryl 7.26 3.67 39 91,100
Novafilb 4.35 2.57 2.94 6.29 4749.4
Gore-Tex (CV-4)a 1.78 1.75 1.42 1.55 1558.8
Biosyna 3.7 2.4 44 2.76b 55.3c
a
3/0 size. b0–10% in kg mm. ckg/mm2.

[213], mechanical and handling properties [214,215] and biodegrada-


tion, and tissue reaction [113,216–218] of PDO.
Im et al. [219] reports the preparation of monofilament suture
(MonoFlexÕ ), composed of poly(p-dioxanone) and its copolymer, by a
conjugate spinning method. They showed that MonoFlexÕ degraded by
hydrolysis, and retained approximately 55% of its original strength after
4 weeks of incubation in PBS at 378C. The suture material was
completely absorbed after 180–210 days post-implantation in rats. No
remarkable tissue reactions were observed during degradation, and
foreign body reactions were similar to those of commercially available
suture materials composed of PDO.
Figure 7 shows the degradation of PDO in comparison with that of
poly(e-caprolactone) (PCL) and MaxonÕ [220]. While PCL is slow, the
degradation of maxon is quite fast so that PDO gives a suture that is fast
enough, but not as slow as PCL. Table 9 compares the mechanical
properties of PDO with those of a number of other sutures in general
use. Kulkarni et al. showed that the enzymatic degradation of
multiblock copolymers consisting of PCL segments and PDO segments
was significantly accelerated by Pseudomonas lipase in contrast to the
hydrolytic degradation, where the degradation behavior was determined
by the PDO segments [221]. A linear correlation between weight loss
and increasing PCL content of the multiblock copolymers was found.
While X-ray diffraction data confirmed the involvement of both
crystalline and amorphous PCL segments, and SEM cross-section
images revealed that Pseudomonas lipase penetrated into the PDO
segments.
Storck et al. point out that there is increasing evidence that this slow-
absorbable suture will gain clinical importance for cardiovascular and

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Absorbable Polymeric Surgical Sutures 329

120

100
% Original strength

80

60

40

20

0
0 10 20 30 40 50 60 70 80
Time (weeks)

PCL MAXON PDS

Figure 7. In vivo degradation of absorbable sutures. (Reproduced from ref. [220] with
permission from Elsevier.)

peripheral vascular surgery in the future, since many experimental and


clinical studies during the last 40 years have proven histologic super-
iority for PDO over nonabsorbable materials [222]. Nonabsorbable
suture material should no longer be used for direct vascular anasto-
moses. Molea et al. conducted a comparative study on biocompatibility
and absorption times of three absorbable monofilament suture materi-
als, PDO, MonocrylÕ , and BiosynÕ to assess their clinical character-
istics, tissue inflammatory reaction, and suture absorption times [223].
MonocrylÕ and BiosynÕ suture materials were found to be less reactive
than PDO in rat skin. However, because of their extremely low tissue
reaction values, all three materials were deemed particularly suitable
for use as intracuticular sutures. Absorption times in rat skin were less
than 3 months for MonocrylÕ , between 3 and 6 months for BiosynÕ and 6
months for PDO. PDO is particularly useful in pediatric cardiovascular
surgery, ophthalmic surgery, etc. where the combination of an absorbable
suture and extended wound support is desirable [224]. It is also useful in

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330 C. K. S. PILLAI AND C. P. SHARMA

preparing barbed sutures that can anchor securely in tissues and obviate
the need for surgical knots [225, 226].
Hong et al. [145] investigated the mechanical properties and
biodegradability of [poly(TMC-e-CL)-block-PDO] copolymers in compar-
ison with PDO and MonocrylÕ monofilaments in vivo and in vitro.
Poly(TMC-e-CL)-block-PDO copolymer was prepared by using ring
opening polymerization reaction [144]. The implantation studies of
absorbable suture strands performed in gluteal muscle of rats showed
that these polymers, poly(TMC-e-CL)-block-PDO, PDO, and MonocrylÕ ,
were semi-crystalline with 27%, 32%, and 34% crystallinity, respectively.
The mechanical properties of poly(TMC-e-CL)block-PDO were compara-
tively lower than those of the other polymers. The biodegradability of
PDO was the lowest among these polymers.
PDO and MaxonÕ sutures are known to reduce complications in the
healing of the wound significantly. Vracko and Pegan [227] analyzed the
frequency of the complications in the healing of the operative wound on
114 and 108 patients upon the biliary tract with a subcostal incision and
closed in one layer with PDO and MaxonÕ sutures. The difference in the
development of complications in the healing of the surgical wound
between the two drained groups was not statistically significant.
The longer dissolution time of PDO was utilized by Anderson et al.
[228] to prevent local sepsis and anastomotic leakage developing from
short dissolution time and multifilament structure of sutures such as
VicrylÕ . In a study of 98 rat colonic anastomoses, no difference was
found in complication rates or cellular reaction to the suture material
between VicrylÕ and PDO [228]. PDO sutures were also shown to
maintain their strength in a 28-day observation period in a repair
operation involving 36 canine flexor digitorum profundus tendons using
5-0 MaxonÕ or PDO monofilament [229]. All the tendons healed without
rupture or formation of gaps of more than 2 mm. MaxonÕ repairs were
initially superior in gap and ultimate strength to PDO repairs. However,
the gap and ultimate tensile strength of MaxonÕ repairs had decreased
significantly at day 14. PDO was shown to be a safe alternative to
standard sternotomy closure after pediatric open cardiac surgery by
Keçeligil et al. [230].
The ease of handling and knot performance of sutures are parameters
that concern the surgeon during surgery [231]. Studies on three
monofilament sutures, ProleneÕ , BiosynÕ , and PDO, and one braided
polyester suture (SurgidacÕ ) showed that ProleneÕ and BiosynÕ sutures
gave improvements in loop elongation and loop-holding capacity over
PDO, with the Snyder knots being consistently superior to Duncan
knots. BiosynÕ gave no improvement over PDO. Both ProleneÕ and

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Absorbable Polymeric Surgical Sutures 331

SurgidacÕ sutures gave superior knot performance to PDO, but only


ProleneÕ gave equivalent ease of manipulation. As a result, there may be
clinical advantages in replacing PDO with ProleneÕ or SurgidacÕ
sutures for certain arthroscopic procedures. The PDO suture, however,
was found significantly better than catgut in terms of pliability, ease of
passage through tissue, ease of tying, strength, fray resistance, and
overall handling properties.
PDO would appear to be particularly useful in situations requiring
extended wound support, in potentially infected wounds in which a
monofilament suture would have lessened tendency to harbor patho-
genic bacteria, and in cases where ease of passage through tissue,
smooth tie-down, and precise knot placement are important [232].
Various sizes of undyed monofilament PDO surgical suture were
assessed in 52 surgical patients who underwent plastic surgery. With a
single exception, follow-up observations were carried out for at least
40 days. Clinical results were judged satisfactory in 13 patients and
excellent in 39 patients.
PDO was shown to lose its shape totally within 2 months in a study
involving foreign body reaction, capsule formation, and mechanical
properties [233]. In another study, Sasaki et al. investigated the
durability of plain catgut and CG, VicrylÕ Rapid, PGA, PDO,
ProleneÕ , and silk sutures in human pancreatic juice and bile [234].
Plain catgut and CG disintegrated in pancreatic juice and pancreatic
juice plus bile mixture. PGA and VicrylÕ Rapid suture materials were
vulnerable to pancreatic juice within 7 days. PDO retained most of its
initial strength in pancreatic juice and bile. ProleneÕ and silk retained
84% and 92% of their initial strength, respectively. The authors found
that PDO was the strongest suture material in pancreatic juice. PDO
sutures are, however, reported to undergo bending, curling, or stripping
away (the barbs) from the suture body after extraction in an
experimental study [235].

Poly(e-Caprolactone) (PCL)

PCL is produced by the ROP of e-CL. It is a semi-crystalline polymer


with a melting point of 59–648C and a glass-transition temperature of
608C. The polymer has been regarded as tissue compatible and used as
a biodegradable suture in Europe. The polymer undergoes hydrolytic
degradation due to the presence of hydrolytically labile aliphatic ester
linkages in physiological conditions (such as in the human body) [124].
Because the homopolymer has a degradation time on the order of
2 years, copolymers have been synthesized to accelerate the rate of

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332 C. K. S. PILLAI AND C. P. SHARMA

bioabsorption. For example, copolymers of e-CL with DLL have yielded


materials with more-rapid degradation rates. The introduction of
monofilament sutures of e-CL and GL (MonacrylÕ ; Scheme 5) solved
many of the problems with braided sutures that relate to tissue drag and
the trauma as well as the possible potentiation of infection through the
interstices of the braid structure. Another bioresorbable (SynBiosysÕ )
multiblock copolymer composed of e-CL, GL, LL, and poly(ethylene
glycol) units has been developed as a drug delivery vehicle for small and
medium sized biologically active molecules. PCL has low tensile strength
(approximately 23 MPa) but an extremely high elongation at break
(4700%) [196]. PCL is also an FDA approved material.
Bezwada et al. [149] showed that MonocrylÕ sutures displayed
excellent handling properties, minimal resistance during passage
through tissue, and excellent tensile properties. Absorption data on
these sutures indicate that absorption is complete between the 91st and
119th days of implantation, with slight or minimal tissue reaction [149].
The biodegradability of MonocrylÕ sutures is much better than that of
PDO [144].
A copolymer of LL, e-CL, and TMC was used as a suture coating for a
PGA suture that could contain an antimicrobial agent like triclosan. A
total release of triclosan is attained after a few days of exposure to a
Dulbecco’s based medium, whereas equilibrium concentrations are
reached when a Sörensen hydrophilic medium is used [146].

Poly(Trimethylene Carbonate) (PTMC)

ROP of TMC gives high MW weight flexible PTMC. Unlike the


previously described polyesters, PTMC undergoes surface degradation.
The rate of in vivo degradation was found to be much higher than
in vitro degradation. This is presumably due to the contribution of
in vivo enzymatic degradation process [124]. The low mechanical
performance of the homopolymer led to the development of several
co/terpolymers such as MaxonÕ and BiosynÕ (Schemes 6) with other
cyclic lactones. A comparison of mechanical properties of MaxonÕ and
BiosynÕ is given in Table 10 [98,99,114,208,216,222].
MaxonÕ was formulated to combine predictable in vivo performance of
synthetic absorbable suture with the handling characteristics of a
monofilament suture [94,98,101,114,227]. The studies carried out in
rats showed cumulative strength retention of 81% at 14 days, 59% at
28 days, and 30% at 42 days [98]. Histologic assessment of absorption
obtained from serial sections at intervals of 3–9 months showed that, in
sizes 00 and 4-0, complete absorption occurred between 6 and 7 months.

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Absorbable Polymeric Surgical Sutures 333

Table 10. A comparison of mechanical properties of Biosyn and Maxon sutures


[99,99,208,217,222].

Physical property Biosyn (3/0) Maxon (3/0)


Diameter (mm) 0.29 0.293
Knot pull strength (kg) 2.4 2.9
Young’s modulus (kpsi) 145 425
Straight-pull strength (kg) 3.7 3.9
Elongation (%) 44 30
Tensile strength (kg/mm2) 55.3 56.2

The authors believe that the absorption of these sutures was achieved
through the action of mononuclear and multinuclear macrophages
which were confined to the implant and sequestered by a fibrous
connective tissue capsule. The results of studies of radiolabeled sutures
carried out in the subcutaneous tissues of rats revealed urine and
expired CO2 to be the major excretory routes of the metabolites. These
sutures thus were shown to maintain good strength with little or no
absorption during the critical wound healing period with minimal tissue
reaction. Hydrolytic degradation studies showed that changes in
mechanical properties of the copolymer were found to be strongly
dependent on changes in the value of Mn [203].
BiosynÕ has, however, been shown to exhibit more problems on
suturing after childbirth in a comparative study with the multifilament
suture Dexon IIÕ [236]. Women who required suturing by midwives
were allocated for repair with either the multifilament suture Dexon IIÕ
or with a new monofilament of BiosynÕ . The results at follow-up after
8–12 weeks indicated that more women in the monofilament group
reported problems with the sutured area.

Polyhydroxyalkanoates

PHAs are polyesters produced by micro-organisms (like Alcaligenes


eutrophus or Bacillus megaterium) as energy storage materials [237–
239]. The most common PHA, poly(3-hydrobutyrate) (PHB), is a semi-
crystalline polyester (Figure 8) that undergoes hydrolytic degradation by
surface erosion, making it an attractive material for controlled release
applications. It has relatively high melting point and crystallizes rapidly,
making entrapment of drug technically difficult. The related copolymers
with 3-hydroxyvalerate, P(3HB-co-3HV)s, have similar semi-crystalline
properties though their slower rates of crystallization result in matrices
with different properties. PHB and P(3HB-co-3HV) matrices lose mass

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334 C. K. S. PILLAI AND C. P. SHARMA

CH3 O

O HC CH2C

n CH3 O CH2CH3 O
PH3B
O HC CH2C O CH CH2C

CH2CH3 O n
PHBV
O HC CH2C

n
PHV

Figure 8. Structures of PH3B, PHV, and PHVB.

very slowly when compared to bulk-degrading PGA systems. The


biocompatibility is good and hence is suitable for medical applications.
It has a melting point is 1758C and glass transition temperature 158C
and tensile strength 40 MPa (close to that of PP). It sinks in water (while
PP floats), facilitating its anaerobic biodegradation in sediments. It is
fully nontoxic [240]. However, the commercialization of PHA sutures is
impeded by the high cost of its production.
A comparative evaluation of the tissue reaction of PHA sutures with
silk and catgut after implantation to test animals intramuscularly
showed that PHB and P(3HB-co-3HV) sutures implanted intramuscu-
larly for an extended period (up to 1 year) did not cause any acute
vascular reaction at the site of implantation or any adverse events, such
as suppurative inflammation, necrosis, calcification of the fibrous
capsule, or malignant tumor formation [79]. No statistically significant
differences were revealed in the tissue response to polymer sutures of
the two types. Capsules around silk and catgut sutures did not become
significantly thinner.
Tested monofilament sutures made of PHB and P(3HB-co-3HV)s
exhibited the strength necessary for the healing of muscle-fascial
wounds [79]. Chen et al. [241] investigated degradation behavior of
monofilament suture made from P(3HB-co-3HV) both in lipase solution
and by implant into rat tergal muscles. Results showed that the
monofilament suture lost its tensile strength gradually accompanied by
decrease of MW. Rat implantation showed no remarkable tissue
responses during in vivo degradation. Foreign body reactions were
much milder than chromic catgut, which is one of the most common
commercially available sutures.

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Absorbable Polymeric Surgical Sutures 335

0.4
Rate of enzymatic erosion (mg/h/cm2)

0.2

0
0 20 40 60 80 100 120
Second monomer fraction (mol%)

Figure 9. Rates of enzymatic erosion of various PHA copolymer films in the aqueous
solution of PHA depolymerase (from Alcaligenes faecalis) at 378C and pH 7.4. () P(3HB-
co-3HH), (h) P(3HB-co-3HV), (*) P(3HB-co-3HP). HB – hydroxy butyrate, HV –
hydroxyvalerate, and HP – hydroxyl propionate. (Reproduced from ref. [243] with
permission from ACS Publications.)

The effect of the conditions of storage and crystallization of PHB on


the transport properties of PHB coating on surgical sutures was
demonstrated [242]. The effect of the storage conditions is leveled by
incorporating a second biocompatible polymer in the coating. Storage in
a freezer at 208C is recommended for preserving the antimicrobial
activity of sutures with a PHB coating. Figure 9 shows that the
biodegradation can be controlled by controlling the composition of the
copolymer [243].

Antimicrobial Sutures

Wound infection is considered to be one of the oldest and most


common complications in all types of injuries. The presence of

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336 C. K. S. PILLAI AND C. P. SHARMA

foreign materials in wound has been known to enhance the


surrounding tissues to wound infection. Suture materials are the
probably the most important biomaterials in wound infection because
the infection begins along or near suture lines. The use of
antimicrobial sutures is expected to provide protection from wound
infection. Several approaches have been reported in developing
antimicrobial sutures. The incorporation of silver metal on the
surface of sutures is one of the approaches adopted to impart
antimicrobial activity to sutures [244].

Sutures Based on Chitin


One of the most promising biomaterials that can accelerate wound
healing is the natural polysaccharide known as chitin that contains
N-acetyl glucosamine (NAGA) moiety as repeating unit. Chitin is, thus,
poly(N-acetylglycosamine), the linear polymeric structure of which is
expected to give rise to fiber formation and film-forming ability similar
to those of cellulose [245]. NAGA can be found in certain essential
human glycoproteins in connective tissues like hyaluronic acid and
keratin sulfate. The glucosamine moiety in chitin has been shown to
exhibit a variety of biological functions, such as anti-inflammatory,
hepatoprotective, antireactive, and antihypoxic activities. The NAGA
derivatives are also shown to exhibit antitumor effect [246]. In addition
to its potential antitumor effect, chitin, and its derivatives have been
reported as possible wound healing accelerators. Chitosan (CS), the
deacetylated form of chitin, has been reported to have antimicrobial
activity against Gram-positive pathogens like Staphylococcus aureus,
Staphylococcus epidermidis, and Staphylococcus haemolyticus
[247–250]. A possible mode of action for chitin derivatives in wound
healing is one in which glycosaminoglycans play a role in the structural
organization of collagen [251].
Although chitin fibers could be made into textile materials, chitin
sutures have remarkable properties over other fibers for biomedical
applications [252–255]. One study reports that chitin fibers have
comparable properties to those of collagen and lactide fibers [256]. By
the mid-1950s, chitin-coated sutures were being used, which enhanced
healing time by 35–50%. Chitin sutures resist attack in bile urine and
pancreatic juice, which are problem areas with other absorbable sutures
[257].
The preparation of chitin threads for use in the fabrication of
absorbable suture materials, dressings, and biodegradable substrates for
the growth of human skin cells has been reported [258,259]. The
wet-spinning process has been employed to prepare chitin sutures.

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Absorbable Polymeric Surgical Sutures 337

The process used strong polar protic solvents such as trichloroacetic acid
(TCA), dichloroacetic acid (DCA), etc. to dissolve chitin. Kifune et al.
[260] reported a process for the production of chitin fibers having high
tensile strength and flexibility, suitable particularly for the preparation
of absorbable surgical sutures. In the 1970s, Brine and Austin developed
a method to spin pure chitin filaments. A Japanese firm bought the
patent rights, and suture materials are now manufactured in Japan
[261,262]. A number of similar patents and processes have also been
reported wherein various highly polar solvents and solvent mixers were
used [263–268]. Although dry tenacities of above 3 g/denier were
obtained, the low wet tenacities were still undesirable. In addition,
chlorohydrocarbons are solvents that are increasingly becoming envir-
onmentally unacceptable.
Spun chitin filaments developed in the 1970s for sutures were shown
to enhance healing time by 35–50% and are fully absorbed by the body
[78,269,270]. It is reported that chitin is a suitable material for
absorbable, flexible sutures for use in contact with bile, urine, and
pancreatic juices, which are problem areas with other absorbable
sutures [271]. The sutures developed from chitin with sufficient
strength and flexibility were absorbed in about 4 months in rat muscles
without any adverse effect [251].
Chitin is, thus, an absorbable suture material with suitable
mechanical properties. Tissue reaction is not specific and the good
healing which ensued provided evidence for a satisfactory biocompat-
ibility. Toxicity tests, including acute toxicity, pyrogenicity, mutageni-
city, etc. were negative in all respects. The chitin suture was absorbed
in about 4 months in rat muscles. The persistence of the tensile
strength of the chitin was better than DexonÕ or catgut in bile, urine,
and pancreatic juice but weakening occurred early in the presence of
gastric juice [78]. Application in 132 patients proved satisfactory in
terms of tissue reaction and good healing indicating satisfactory
biocompatibility [272]. In a study of the comparative evaluation of four
absorbable suture materials, chitin, PGA, plain catgut, and CG,
Tachibana et al. observed that the TSR of chitin in muscle was 45%
at 14 days and 7% at 25 days, which was similar to that of PGA. The
TSR of chitin was maintained by 35% in gastric juice, 97% in bile, and
100% in pancreatic juice after immersion for 30 days. The correspond-
ing values for PGA were 54%, 0%, and 0%, respectively, whereas both
catguts had dissolved within 30 days. The tissue reaction of chitin was
similar to that of PGA [77].
The importance of chitin suture materials is on the increase as can be
witnessed by several publications [78,273–280]. Biodegradable

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338 C. K. S. PILLAI AND C. P. SHARMA

polyurethane (PU) elastomers with potential for biomedical application


as nonabsorbable sutures with improved hydrophobic properties were
synthesized by modification of chitin by the reaction of CL and 4,40 -
diphenylmethane diisocyanate, extended with different mass ratios of
chitin and/or 1,4-butanediol (BDO) [280]. The results of different tests
demonstrated that the synthesized products are potential candidates as
nonabsorbable sutures as previously investigated into their in vitro
biocompatibility and nontoxicity [281–284]. Optimum hydrophobicity
was obtained from elastomer extended with chitin in comparison to
elastomers extended with BDO. The surface free energy was also
affected by chemical composition of the final PU. Structure–property
relationship for the prepared elastomers showed that the main
determining factors were hydrogen bonding, hydrophobicity, and
content of chitin in PU backbone. Xiong et al. [285] have shown that
chitin suture has a potential to construct tissue engineering skeletal
muscle. When chitin was cultured with myoblast L6 of rats in vitro, they
observed a parallel arrangement of scaffold that can control the
directivity of tissue engineering skeletal muscle fibers.
Chitin with enhanced tensile strength (4 g/denier) and modulus (100 g/
denier) was produced from chitin or CS acetate/formate polymer
[286,287]. Fibers spun from lyotropic liquid crystalline solution possess
highly oriented chains both in amorphous as well as crystalline regions
and thus offer higher breaking strength and modulus [288]. Knaul et al.
showed that the properties of chitin produced by microwave-medicated
reaction are at par with those derived from conventional chemically
modified ones [289,290]. A blend of CS konjac glucomannan (KGM)
fibers showed good antibacterial activity to S. aureus. The structure
analysis by Fourier transform infra red (FTIR) spectrometry, SEM, and
X-ray diffraction (XRD) methods indicated that there were strong
interaction and good miscibility between the CS and KGM molecule
which resulted from strong intermolecular hydrogen bonds [291]. Novel
bioactive cellulosic-CS fibers could be developed by coating cellulose with
CS [292].

Biodegradation of Chitin Fibers


Chitin is considered to be highly biodegradable and easily excreted in
urine [293]. When attacked by natural fungi, CS films have a built-in
source of nitrogen to enhance biodegradation. It is generally believed
that lysozyme is mainly responsible for CS degradation in the human
body [294–298].
The biocompatibility and safety of CS has been revealed through
tests involving mutagenicity, acute and subacute toxicity, hemolysis,

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Absorbable Polymeric Surgical Sutures 339

and sensitization [299,300]. The US FDA considers CS as a food


additive in animal feed when used as a precipitating agent for
proteineceous materials [298]. No abnormal symptoms were observed
when CS was orally administrated to rabbits, broilers, and hens at a
dosage of 0.7–0.8 g/kg body weight/day for upto 239 days [299,300].
Rabbits also did not exhibit any abnormal symptom when CS was
intravenously injected. It was also observed that the presence of CS
enhanced the absorption of drugs when administrated orally [301–306].
The characteristic property of an ideal surgical suture consists of easy
biointegration and tissue adaptation until healing occurs without
disturbing the healing process. It should also disappear on completion
of healing. The currently available absorbable sutures such as alginate,
collagen, catgut, and branan ferulate have limitations and not always
satisfactory. On the other hand, chitin as a wound healing accelerator
has great potentialities from the point of view of absorbable surgical
sutures.

Recent Developments in Antibacterial Sutures


This is an area that is fast developing as can be seen from the
worldwide interest shown by several groups [307–326]. Anti-microbial
surgical sutures, which for a long period provide the wound with the
antibiotics settled in their structure, can be of considerable use for
precautions and treatment of surgical sepsis [309]. Tsai et al. [307]
studied the antibacterial property of a newly made, silver compound
coated braided Nylon suture. It was observed that the antibacterial
property of the suture was depended upon the type of bacterial species.
For example, a difference of almost 103 in the number of Pseudomonas
aeruginosa was observed within a period of 6 h when tested on three
representative bacterial species, S. aureus, Escherichia coli, and
P. aeruginosa. The responses of S. aureus and E. coli to the silver
compound coated Nylon thread, however, were not as drastic as
P. aeruginosa [244].
Blaker et al. [310] have used antimicrobial coatings of silver-doped
bioactive glass (AgBG) on resorbable VicrylÕ and nonresorbable
MersilkÕ surgical sutures and compared their thermal properties. The
results showed that the bioactive glass coating did not affect the
dynamic mechanical and thermal properties of the sutures [310].
Rozzelle et al. [311] showed that the use of antimicrobial suture for
cerebrospinal fluid shunt surgery wound closure is safe, effective, and
may be associated with a reduced risk of post-operative shunt infection.
Incorporation of antibacterials such as triclosan is used to impart
antimicrobial activity. In a randomized prospective clinical study

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340 C. K. S. PILLAI AND C. P. SHARMA

comparing the use of two absorbable sutures, VicrylÕ Rapid versus


VicrylÕ , Al-Qattan reported that VicrylÕ Rapid sutures were more
suitable than VicrylÕ ones in pediatric hand surgery [312]. It was also
demonstrated by Storch et al. [313] that VicrylÕ Rapid suture with
triclosan inhibits bacterial colonization of suture after direct in vivo
challenge with S. aureus in a guinea pig model. Marco et al. also studied
the efficacy of a new antibacterial suture coated VicrylÕ Plus suture
(VicrylÕ containing triclosan) and compared it with the traditional
braided suture, VicrylÕ , in a validated animal model of orthopedic
infection [314]. No clinical signs of infection were observed. They found
predominant polymorphonuclear neutrophil populations in four samples
in the VicrylÕ group versus two in the VicrylÕ Plus with triclosan group.
Under simulated conditions of severe intraoperative contamination, the
antibacterial suture reduced the number of positive cultures after
surgery by 66.6%. The authors concluded that judging from the available
clinical information, its use might contribute to reducing the number of
infected implants by 25.8%.
Suture materials are also chemically treated to introduce groups such
as carboxyl groups for antimicrobial drug immobilization [315]. This
was demonstrated by preparing PP-graft-polyacrylonitrile (PP-g-PAN)
sutures by graft copolymerization of acrylonitrile onto PP monofilament
using a pre-irradiation method. The grafted PP monofilaments were
subsequently hydrolyzed to introduce carboxyl groups for antimicrobial
drug immobilization. In general, the hydrolysis did not cause any
significant variation in crystalline structure.
In another work, antimicrobial activity was imparted to weaved
polyester fiber based sutures by coating PHB, containing the anti-
microbial agent furazolidone (FZ) [316]. The prolonged FZ effect (7–14
days) is achieved by two-step application of a sheath, constituting 10% of
the suture weight and containing 2–6% FZ. The sheath structure and
antimicrobial activity of sutures can be modified by the introduction of
other biocompatible and biodegradable polymers.
Bide et al. studied the interaction of an antibiotic compound with
common suture materials such as silk, Nylon, and polyester and
compared its uptake, release, and subsequent long-term antimicrobial
effectiveness [317]. Dye-like incorporation provides infection resistance
that persists over days or weeks as opposed to hours for the dipped
material. Gupta et al. reports the development of antimicrobial PP
sutures by graft copolymerization of 1-vinylimidazole onto PP mono-
filament sutures [318,319]. They are subsequently immobilized with an
antimicrobial drug, ciprofloxacin. The modified suture releases the drug
over a period of 4–5 days.

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Absorbable Polymeric Surgical Sutures 341

CapromedÕ threads are demonstrated to have high strength char-


acteristics and resolve in the body within 8–9 months [320].
Experimental studies of antibacterial properties revealed that their
implantation in animal tissues induced active desorption of antibiotics.
Antibiotic desorption from the CapromedÕ suture material facilitates
wound healing, prevents ligature fistulas, and reduces the rate of post-
operative complications by a factor of 4. Contaminated wounds closed
with sutures had higher infection rates compared with those repaired
with topical tissue adhesive [321].

The Emerging Perspectives

The scope and future perspectives for surgical suture materials appear
to be vast as can be noted from several new publications emerging in the
area. Suture application varies for different tissues, different patients,
and different circumstances. The availability of a large array of new
sutures, staples, tapes, and topical adhesives can make the proper choice
for closure a challenge. The present day user qualities of biologically
inert, synthetic, absorbable, and nonabsorbable threads have approach-
ing the limit of the requirements imposed by modern surgery. This
necessitates further progress in this area which can be noted from the
renewed interest in developing novel concepts and designs for the
production and manufacturing of strong and elastic threads made of
biocompatible absorbable natural (e.g., chemical modifications of PHAs,
collagen, chitin, alginate, etc.) or synthetic polymers.
With the increasing complexity and technical requirements of internal
surgery, absorbable sutures that get gradually degraded and absorbed
with the healing of wounds are required. Absorbable sutures such as
PGLA and PDO have tremendous development value and have bright
application prospects because of excellent biocompatibility, absence of
tissue reaction, high strength and toughness, moderate stretchability,
lack of toxicity and irritation, and controllable degradability. Owing to
these excellent properties and extensive application sectors, they earned
widespread attention as medical-care materials in the textile sector
globally. PDO and its copolymers having good workability and strong
penetration enable accurate joining of tissues without damage, thus
making it possible for them to be used in surgeries using continuous
stitching.
One of the most interesting developments in recent times is the smart
suture that can be used to seal difficult wounds where access is limited
[322]. The suture contracts to its permanent shape when heated and its
self-knotting action occurs when it is heated a few degrees above normal

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342 C. K. S. PILLAI AND C. P. SHARMA

body temperature. It uses a shape memory polymer (SMP) that contains


a hard segment and a ‘switching’ segment, both having different
thermal properties. One segment melts, or makes another kind of
transition, at a higher temperature than the other. By manipulating the
temperature and stress applied to the overall material, Langer and
Leindlin [322] end up with a material that forms a temporary shape at
one temperature, and a permanent shape at a higher temperature. After
increasing the temperature, the suture material shrinks, creating a knot
with just the right amount of tension on the surrounding tissue. It is
difficult to create such a knot in the confined spaces associated with
endoscopic surgery. They demonstrated this by creating the first ‘smart’
degradable suture.
Novel bioactive materials have been prepared by coating violet
resorbable VicrylÕ sutures with a bioactive glass powder derived from
a co-precipitation method [323]. With the first wave of bioactive sutures
already in the market place, research is directed to the development of
future products such as sutures that could potentially demonstrate not
only antimicrobial activity but also anesthetic and antineoplastic
functions [324]. A suturing material that serves not to prevent infection,
but to combat bacteria introduced from other sources and to promote
wound healing would represent a significant improvement over
currently used materials.
After resection and repair of the intestines, tissue degradation leads
to weakening of the repair site and risk of post-operative leakage.
Matrix metalloproteinases (MMPs) are thought to be responsible for
collagenolysis in the direct vicinity of surgical sutures in many tissues.
Several experimental studies show that MMP inhibitors administered
systemically alleviate post-operative weakening of intestinal anasto-
moses. This has led to the development of the exciting discovery of
drug delivery by means of MMP inhibitor-coated sutures to improve
tissue integrity during anastomotic repair and to reduce post-operative
complications. Pasternak et al. coated sutures with a cross-linked
fibrinogen film and bound the MMP inhibitor doxycycline into this film
[325]. The sutures were then used in a standard rat model for
evaluating mechanical properties of colonic anastomoses 3 days after
surgery. The breaking strength of the anastomoses on the critical third
day after operation was 17% higher with doxycycline-coated sutures
compared to controls.
The formation of bacterial biofilms on the surface of implanted
materials is a critical factor that may lead to chronic microbial infection
and tissue necrosis. In an interesting study, Harnet et al. [326]
established the great potential of using antibacterial sutures to

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Absorbable Polymeric Surgical Sutures 343

combat the menace. They investigated the stability of polyelectrolyte


multilayer (ML) films on suture materials and the antibacterial effect
obtained with chlorhexidine (CHX)-functionalized films built on
different types of suture materials such as silk, polyester, and PLGA
[326]. They compared E. coli culture on glass coverslips and glass
coverslips with ML and CHX films and observed inhibition of the
bacterial relative luminescence.
Zhukovskii [273] in a recent review has discussed the problems and
prospects for development and production of surgical suture materials.
According to him, the assortment and user qualities of biologically inert,
synthetic, absorbable, and nonabsorbable threads have approached the
limit of the requirements imposed by modern surgery. He anticipates
better manufacturing processes for production of strong and elastic
threads made of absorbable natural polymers – PHAs and their
copolymers, collagen, chitin, CS, alginate, etc. The attention of
investigators is increasingly focusing on suture materials with both
individual and comprehensive biological activity [307–327]. Creation of
thread containing native biological structures (cell growth factor, blood
plasma proteins, cells of different organs and tissues, and other cells,
including those that increase biocompatibility) and self-regulating
materials with biologically active molecules in their structure capable
of markedly altering their properties under small external physical or
chemical effects is promising.
With the introduction of new clinical methods to carry out surgical
operations such as minimally invasive vascular surgery (also called
laparoscopy) [328], it has become imperative that the suture cannot be
handled with fingers and the use of stainless-steel needle holders is
required. In a farsighted experiment, Tremblay et al. investigated the
mechanical and microstructural effects of the manipulations with
laparoscopic needle holder on polymeric suture monofilament [329].
Surgiproß (PP), Tefleneß (polyvinylidene fluoride), and Gore-Texß
(polytetrafluoroethylene) monofilament sutures were pinched with a
standard clinical protocol by a surgeon. Tefleneß and Gore-Texß
monofilament sutures were shown to be unaffected even after severe
pinching with laparoscopic needle holders whereas the properties
decreased significantly for Surgiproß sutures.
As knotting induces decrease in mechanical properties, better
methods of selection and tying of suture materials are required to
ensure maintenance of the tensile and knot security properties.
Introduction of mechanical tying method was found to be a useful
alternative to hand tying and provided reproducible test results
[330,331]. The mechanical properties of damaged suture are important

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344 C. K. S. PILLAI AND C. P. SHARMA

to all surgeons who use suture arthroscopically. So, Wright et al. [332]
measured the mechanical properties of damaged sutures. They noted
that the newer polyethylene core sutures (FiberWire and Orthocord)
have superior mechanical properties which are maintained even
when cut.
Clinicians are often faced with the challenging task of distinguishing
between accidental and inflicted pediatric head trauma. Studies by Coats
and Margulies [333] showed sizeable difference between pediatric bone
and suture material properties that underscored the crucial role that
sutures play in the unique response of the pediatric head to impact in
low height falls. The large strains in the pediatric bone and suture result
in a skullcase that can undergo dramatic shape changes before fracture,
potentially causing substantial deformation in the brain. These data
provide necessary information to enhance our understanding of
mechanisms of head injury in young children.
The combination of sutures and techniques of suturing are expected to
play greater role in future as the awareness on the influence of these
parameters apart from the properties of suture materials on suture
performance is established. Yotsumoto et al. [334] who repaired the
gastrocnemius tendons of 24-week-old cattle (diameter 14–16 
9–11 mm2) with application of a single locking, multiple locking, single
grasping, or multiple grasping technique concluded that mechanical
properties of each tendon suture depended on the particular combina-
tion of suture materials and repair techniques.
Great expectations are raised on the new polyblend sutures that
appear to fill a void in the armamentarium of the surgeon. Wüst et al.
made a comprehensive comparison of the mechanical properties of four
types of braided polyblend sutures with widely used braided polyester
and monofilament PDO sutures [335]. The ultimate strength of
polyblend suture material was 2–2.5-fold greater than that of polyester
or PDO sutures, but the resistance to fraying was up to 500-fold greater
than that of polyester or PDO sutures. With regard to strength, this
makes polyblend sutures particularly advantageous for use with metallic
edges of anchors or prostheses or with absorbable anchor eyelets.
Great developments are expected in the manufacturing processes for
the production of strong and elastic absorbable and nonabsorbable
sutures [132,336,327]. Special technology has been developed for the
production of PP surgical monofilaments to meet medical needs for a
suture material meeting tight specifications for physical and mechanical
properties [336]. Alternate off-line hot-drawing and annealing (three
cycles) were carried out by Chooprayoon et al. to develop the oriented
semi-crystalline morphology in block copolymer of LL and e-CL

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Absorbable Polymeric Surgical Sutures 345

[208,337]. Several new varieties of monofilaments are discussed by De


Breuck [338]. The suture configuration and the nature of suture
material have profound influence on the biomechanical characteristics
of single-row repair in comparison to double-row repair. Baums et al.
[339] have shown that double-row suture anchor repair with arthro-
scopic Mason-Allen/medial mattress stitches provides initial strength
superior to single-row repair with arthroscopic Mason-Allen stitches
under isometric cyclic loading as well as under ultimate loading
conditions.

CONCLUSIONS

Over the years, surgical suture materials have matured as core


products of a mature industry. New sutures are being developed all the
time, to better respond to particular surgical needs. Basic materials are
modified depending on their intended application to provide the surgeon
with a suture material of optimal quality. The present day user qualities
of biologically inert, synthetic, absorbable, and nonabsorbable threads
have approaching the limit of the requirements imposed by modern
surgery. This necessitates further progress in this area which can be
anticipated if manufacturing processes for production of strong and
elastic thread made of biocompatible absorbable natural polymers –
polyoxyalkanoates, collagen, chitin, alginate, etc., are developed. The
attention of researchers is increasingly focusing on suture materials
with potential not only for antimicrobial activity but also anesthetic and
antineoplastic functions.

ACKNOWLEDGMENTS

We thank Dr K. Mohandas, Director and Dr G. Bhuvaneswar, Head,


BMT Wing, SCTIMST for encouragement and for providing facilities.
We also thank Mrs Minimol for rendering help in the preparation of this
article.

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