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Developing Uniform Surgical Suture Size Between USP/EP and Textile Engineering Numbering System
Abstract
The surgeons mainly used absorbable and non-absorbable suture materials. The commonly used suture materials are nylon, polypropylene, polyglactin, silk, polyester, polyglycolic acid, etc. Because of the material’s different densities, the diameter of the sutures is changed. The USP/EP number, which denotes only the diameter of the suture, can mislead the surgeons during the selection of the respective suture material on the basis of diameter. Therefore, an attempt has been made to unify the textile numbering system and the existing USP/EP numbering system by considering the suture material density and diameter together.
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Background:
This review aims to identify publications on quantitative biomechanical testing of surgical knot security and the physical factors that determine knot security and failure.
Materials and methods:
An electronic literature search was performed in accordance with PRISMA guidelines utilizing the PubMed and Google Scholar databases in January 2022 to look for objective biomechanical studies on knot security in surgery using primary terms "knot security" and "biomechanical testing".
Results:
Thirty-six articles were included. (level IV evidence). Twenty-four configurations of surface, laparoscopic and arthroscopic knots were studied. Biomechanical tensile testing was used to evaluate knot security in vitro. Load to failure (N) and elongation at knot failure (mm) were quantified by static and cyclic testing to evaluate the knot holding capacity and failure mechanism by slippage or rupture.
Conclusion:
This review reassures that the knot configuration, suture materials, suture sizes and number of throws are key factors in determining the knot security. Knot configuration has to be simple for laparoscopic and arthroscopic knot due to the confined space of operating site. With the advent of stronger suture materials for high tension surgical reconstructive procedures, there is an unmet need to understand the physical behaviour of the knot and the factors which determine its resistance to slippage or rupture.
Background
The aim of this review was to evaluate the most used suture materials with regards to their inflammatory response, their bacterial adhesion, and their physical properties when used to close oral wounds.
Methods
Four databases (PubMed, Scopus, Dentistry & Oral Sciences, and OVID) were searched to retrieve relevant studies from January 1, 2000, to January 31, 2020.
Results
Out of the 269 articles, only 13 studies were selected as they were relevant and met the systematic review's protocol. These studies showed that almost all suture materials studies (catgut, polyglycolic acid [PGA] sutures, nylon, expanded polytetrafluoroethylene, and silk sutures) caused bacterial adherence and tissue reaction. In nylon and chromic catgut, the number of bacteria accumulated was lowest. Silk and nylon were found to be more impacted than catgut and PGA in terms of physical characteristics such as tensile strength. PGA, on the other hand, was said to be the most susceptible to knot unwinding.
Conclusions
Following an oral surgical operation, all sutures revealed varied degrees of irritation and microbial accumulation. Nonresorbable monofilament synthetic sutures, however, exhibited less tissue response and less microbial accumulation.
Suturing the wound provides temporary mechanical support enabling natural tissue healing. Understanding the inherent material properties of the suture materials facilitates clinical adjustments in the rate of degradation to ensure proper wound healing. This review aimed to summarize the analysis of the factors that contribute to the tensile strength of surgical sutures and the implications of these factors in wound healing. Our initial search criteria used keywords Tensile or Strength or suture material and returned 494 potentially related articles, these were narrowed to just seven key articles pertaining to the analysis of the primary outcome variable which are reviewed in detail here. The physical properties of these materials are substantially affected by the biological conditions of the model system during the period of analysis. Nevertheless, under in vivo conditions decisions on suture materials should take comorbidities like dietary habits, smoking, oral hygiene maintenance into account as they can all have a significant impact on the prevailing physiological conditions at the wound site.
Suture performances include handling characteristics and knot mechanical properties. These performances depend mainly on frictional, flexural, and compressive forces. The interaction between these forces developed inside the suture knot governs the displacement mode and the deformability of the suture yarn inside the knot. In the present work, we studied the effect of manufacturing conditions on structural properties and handling characteristics. Obtained results show that manufacturing parameters have significant impact on slipperiness, flexibility, and compressibility. Consequently, suture performances widely depend on manufacturing parameters. We show that after a hot stretch step, suture structure becomes more uniform and compact. Furthermore, after this treatment, lateral deformation, friction force, and bending rigidity are reduced and knot performances are improved. © 2015, Association Nonwoven Fabrics Industry. All rights reserved.
Background:
Dermatologic surgery generally requires the removal of offending or excessive tissue followed by repair of the resultant defect. The functional and cosmetic outcome is increasingly important as patients' expectations grow and physicians become increasingly aware of surgical materials and techniques that enable them to repair defects in a functionally and cosmetically appealing manner.
Objective:
To perform an updated and thorough review of the literature regarding sutures, surgical tape, tissue adhesives and stitching techniques.
Materials and methods:
A comprehensive literature review was conducted on-line via multiple search engines and sites using the keywords suture, suture techniques, suturing techniques, surgical techniques, surgical tapes, surgical adhesives, and tissue adhesives.
Results:
There are numerous articles on sutures, surgical tape, and tissue adhesives, but there are no current articles that review them together in a comprehensive manner and combine the review with a discussion of stitching techniques.
Conclusion:
Suture choice and surgical and stitching techniques may be guided by the TAFT concept of wound closure that recognizes the main function of suture and closure devices: Tension relief; Apposition enhancement; and surface Finishing Touches. The dermatologist's goal is to create functionally and aesthetically pleasing scars for optimal patient satisfaction, which is of ultimate importance considering that the scars patients receive leave a lasting impression of their dermatology experience.
Comprehensive studies comparing tensile properties of sutures are over 25 years old and do not include recent advances in suture materials. Accordingly, the objective of this article is to investigate the tensile properties of commonly used sutures in cutaneous surgery. Thirteen 3-0 sized modern sutures (four nonabsorbable and nine absorbable) were tensile tested in both straight and knotted configurations according to the procedures outlined by the United States Pharmacopeia. Glycomer 631 was found to have the highest failure load (56.1 N) of unknotted absorbable sutures, while polyglyconate (34.2 N) and glycomer 631 (34.3 N) had the highest failure loads of knotted absorbable sutures. Nylon (30.9 N) and polypropylene (18.9 N) had the greatest failure loads of straight and knotted nonabsorbable sutures, respectively. Polydioxane was found to have the most elongation prior to breakage (144%) of absorbable sutures. Silk (8701 MPa) and rapid polyglactin 910 (9320 MPa) had the highest initial modulus of nonabsorbable and absorbable sutures, respectively. The new data presented in the study provide important information for guiding the selection of suture materials for specific surgeries. © 2014 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2014.
The image-processing method, based on Photoshop software, was used to analyze the fiber distribution pattern in yarn cross section for vortex-spun yarn. Fiber packing density and fiber effective packing density, as well as the fiber migration index, were investigated to provide a better understanding of the internal structures of vortex-spun yarn. The research results indicate that the vortex-spun yarn has a lower fiber packing density value than the conventional ring-spun yarn at the yarn center and surface. For the bamboo pulp fiber/white cotton blend vortex-spun yarn, the bamboo pulp fibers are more easily distributed in the yarn core. In addition, the coarser the vortex-spun yarn, the higher the migration level of the bamboo pulp fiber tending to migrate towards the inner layer of the blend yarn.
In this paper the models of morphological structure with respect to shape and packing properties of yarn cross-section are analysed. Classification of the modes of yarn cross-section shapes is proposed. According to this classification four types of yarn cross-section shapes, i.e., basic, derivative, combinative, and compound are distinguished. The possibility to compare different models is discussed also the main assumptions on this point are suggested. The hypothetical cross- sectional models, namely open packing, quadratic packing, solid packing, close packing, etc. are compared. Some new suggestions are made for the comparison of the close-packed and open-packed yarn models. Keywords: cross-sectional model, yarn cross-section, yarn packing, yarn structure.
The purpose of the study is to review the history and innovations of sutures used in pelvic surgery. Based on a review of the literature using electronic- and hand-searched databases we identified appropriate articles and gynaecology surgical textbooks regarding suture for wound closure. The first documented uses of suture are explored and then the article focuses on the use of knotted materials in pelvic surgery. The development of suture of natural materials is followed chronologically until the present time where synthetic suture is implanted during countless surgeries every day. This millennial history of suture contains an appreciation of the early work of Susruta, Celsus, Paré and Lister, including a survey of some significant developments of suture methods over the last 100 years. Most surgeons know little about the history and science of sutures. A retrospective view of suture is critical to the appreciation of the current work and development of this common tool.
Surgeons must select the optimal suture materials for tissue approximation to maximize wound healing and scar aesthetics. Thus, knowledge regarding their characteristics is crucial to minimize ischaemia, excess wound tension, and tissue injury. This article describes the selection of various suture materials available today and their intended design. Modern suture material should have predictable tensile strength, good handling, secure knot-tying properties, and could be enhanced with an antibacterial agent to resist infection. Tensile strength is limited by suture size. The smallest suture size that will accomplish the purpose should be chosen to minimize tissue trauma and foreign material within tissues. Monofilament suture has lower resistance when passed through tissues, whereas multifilament sutures possesses higher tensile strength and flexibility but greater tissue friction and pose risks of suture sinus and infection. Natural absorbable sutures derived from mammalian collagen undergo enzymatic degradation whereas synthetic polymers undergo hydrolysis. Collagen or polymer structures in the suture can be modified to control absorption time. In contrast, nonabsorbable sutures typically cause an inflammatory reaction that eventually encapsulates by fibrous tissue formation. Excess reaction leads to chronic inflammation, suboptimal scarring, or suture extrusion. More recently, barbed sutures have transformed the way surgeons approximate wounds by eliminating knots, distributing wound tension, and increasing efficiency of closure. Similarly, modern skin adhesives function both as wound closure devices as well as an occlusive dressing. They eliminate the need for skin sutures, thus improving scar aesthetics while sealing the wound from the external environment.
In a staple yarn, the composition, distribution and arrangement of fibres can influence its properties. Arrangement and distribution of fibres in a yarn being spinning system dependent, any change in the system causes variation in product performance. Here, an attempt has been made to investigate the fibre distribution in Eli-Twist yarn and it comparison with that of ring spun TFO and SIRO yarn. Yarns of three compositions from cotton and polyester were produced on Eli-Twist, TFO and SIRO spinning systems. Three different counts (39.4, 29.5 and 23.6 tex) from each composition were produced maintaining 40 twist factor for each. Fibre distribution, yarn cross-section, average packing density and number of fibre in yarn cross-section in Eli-Twist yarn were measured and compared with conventional ring spun TFO and SIRO yarn. Migration index helped in identifying the location of fibre in blended yarn. In the polyester–cotton yarn, polyester had a preferential tendency to predominate near the core. Average packing density in Eli-Twist yarn was found to be higher than that of ring spun TFO and SIRO yarn.
Geometrical shape of fibre cross section affects its degree of association with the surrounding fibres and thereby decides physical, mechanical and functional properties of yarn. While a circular cross section brings close proximity between fibres, non-circular fibres inhibit this. Proximity between fibres affects inter-fibre spaces and thus many properties of yarn and corresponding fabrics. The present study, reports on the influence of profiled polyester fibre with micro-channels on its surface and within on the fibre packing and wicking behavior of spun yarn. Five profile polyester fibres, viz; 4DG, circular hollow, conjugate hollow, octalobal and trilobal were used in the study. Yarns made from conjugate and trilobal fibres were found to have highest and lowest packing fraction respectively. Wicking height and wicking rate was the maximum for octalobal fibre yarn followed by 4DG and hollow, trilobal and conjugate fibre yarn. The doubled yarns have shown greater wicking height and wicking rate in comparison to single yarn.
Introduction Put most simplistically, operative surgery consists of nothing more than cutting the body’s tissues and subsequently sewing them back together again. Therefore to the uninitiated it probably seems that the whole issue of suture materials is simple to understand. There are, however, probably few surgical subjects that generate as much heated debate as the ‘correct’ use of the ‘appropriate’ suture in a particular clinical situation. All surgeons have their own opinions as to the ideal suture material for each situation but sadly this is a decision that is often based on habit, tradition or whim. Surgeons thus empirically find the suture material which best suits them. Therefore different surgeons will often use quite different materials and dimensions of sutures for the same purpose. With increasing knowledge about the physical properties of different suture materials and the tissue reactions to these materials, it becomes increasingly clear that for a given purpose one suture or type of suture is often far more suitable than others are. The purpose of this chapter is therefore to guide the reader through the suture options available, whilst outlining some of the reasons why the diffuse variety of sutures and needles needs to exist. THE HISTORY OF SUTURE MATERIALS The use of thread for wound closure and for ligature is described in the literature as far back as 2000 BC. Since then a great many materials have been used for these purposes, including dried gut, dried tendon, strips of hide, horsehair, women’s hair, bark fibres and textile fibres of various kinds. The Greeks were leaders in the field of medicine and the Romans later adopted their techniques. Galen, in the second century AD, used silk and harp cord for ligatures as well as strands of animal intestine to close the wounds of Roman gladiators. In the 10th century Rhazes is credited with being the first to stitch abdominal wounds with harp strings made from spun strands cut from animal intestines. Before the introduction of antisepsis the use of sutures and ligatures presented great problems since their application almost invariably resulted in infection. Pus formation and secondary haemorrhage were therefore common complications. The introduction of antisepsis by Lister in 1867 resulted in a considerable improvement in the infection rate.
Fibres being the structural unit of a yarn, its nature, composition and arrangement can influence structure and properties. The performance of yarn changes with arrangement of its constituent fibres. Arrangement of fibres in a yarn being system specific, different spinning system results different arrangement of fibres causing variation in product performance. A change in the arrangement of fibres in an already formed yarn can be brought about by suitable physical and/or chemical treatment. A treatment to remove a component is expected to cause changes in final arrangement of fibres in a yarn. In the present study, polyester/PVA blended yarn was modified through dissolution of the later component. The resultant change in structural arrangement on dissolution was assessed by the change in radial packing distribution of fibres. Migration index, helped in identifying the location that was influenced more in the redistribution. In the parent yarn, PVA had a preferential tendency to predominate near the core. On dissolution of PVA, creation of open space was expected and collapsing of the structure led to a possible rearrangement of fibres and reduction in diameter of yarn. Fibre denier, blend ratio and twist factor were also found to influence packing density both in parent and modified yarn. Unlike published reports, interestingly, an increase in fibre packing density was observed on dissolution of PVA. Average packing density in parent yarn was found to lie at a yarn radius between 0.07 mm to 0.09 mm while for the modified yarn it was between 0.05 mm to 0.07 mm.
The performance of a textile material depends on the arrangement of its constituent fibres. For good mechanical behaviour strong inter fibre cohesion is necessary. In order to impart comfort characteristics, a permeable structure is desired. Staple fibre, by virtue of its limited length and other constraints, cannot produce fully compacted structure. For an optimum performance, a balance between the permeable and cohesive characteristics is necessary. An estimation of the openness of the structure may help in designing product for specific requirement. The degree of openness, however, may be varied through necessary modifications during and post manufacturing stage. In the present study empirical relations have been developed to calculate the equivalent pore diameter and porosity for three different modes of packing in yarns. Theoretical calculation was done for all three possible modes of packing while the experimental evaluations were made using the cross sectional images. The change in pore size and porosity were also estimated for a polyester/PVA blended yarn on removal of PVA component. A comparison of experimentally measured porosity was made with the results obtained theoretically. Hexagonal close packing resulted lowest porosity and experimentally measured values were in close association with the theoretically measured porosity.
In this study a hypothetical model of the close cross-sectional structure of yarn and some peculiarities of close packing are analysed. The aim of our research is to propose new methods for calculating the packing indices of close-packed yarn. As the basis of one method, a mathematical description of each filament (fibre) position in the yarn cross-section was assumed. This method was suggested for a yarn consisting of a finite number of ring layers. Another method was proposed for the case of an infinite number of filaments or ring layers in yarn cross-section. By analysing the simplest basic element of the cross-section, it was shown that in such a case the packing fraction equals 0.906. The results of the current paper and the data published in other scientific works are in good agreement.
Information about suture materials and needles is important, as inappropriate use of a material or needle type can lead to wound breakdown or tissue injury. For example, following trauma, the use of an absorbable suture to repair a scleral rupture can lead to wound dehiscence a few weeks aft erthe repair, and the use of a cutting or reverse-cutting needle on the sclera can lead to choroidal or retinal injury at the time of repair. The surgeon faces several decisions when closing a wound. These decisions include choice of suture and needle, placement of sutures, and type of knot.
The chapter describes properties of materials used for sutures that may be: absorbable or nonabsorbable of varying size made from monofilament, multifilament, twisted or braided threads. The characteristics of a large number of synthetic suture materials are described, together with essential suture properties such as tensile strength, knot strength, elasticity, tissue reaction and biodegradability. The interrelated nature of the essential physical and mechanical, handling, biological and biodegradation properties is emphasized. The use of dyes and coatings to improve suture identification and properties is also covered.
After introductory chapters on fibre structure, testing and sampling, the book reviews key fibre properties, their technical significance, factors affecting these properties and measurement issues. Each chapter covers both natural and synthetic fibres, including high-performance fibres. The book first reviews properties such as fineness, length and density. It then considers thermal properties and reaction to moisture. A further group of chapters then reviews tensile properties, thermo-mechanical responses, fibre breakage and fatigue. Finally, the book discusses dielectric properties, electrical resistance and static, optical properties and fibre friction.
This study is aimed at determining the packing densities of yarns produced by different spinning systems to investigate the fibre distributions for each system. For this purpose, 100% Tencel LF yarns with 19.69 tex linear densities are produced on ring, compact and vortex spinning systems. Cross-sections have been made by hard sectioning method using a rotary microtome. Packing densities of yarns are calculated by image analysis method. Results show that the compact yarns have the highest packing densities while vortex yarns have the lowest. However, differences between the packing densities of ring and compact yarns are not found statistically significant. In this study, density values of yarns (D, g/cm(3)) are also measured by Uster Tester 5 to evaluate the relationship between the packing density and yarn density values. Results show that the packing density values are parallel to yarn density values.
In the first part of this paper, the geometry of twisted yarns is analysed and, by the introduction of the term “basic” twist (defined as twist per unit of untwisted length), some interesting and apparently new relations are obtained which show why there is a limit to twist and why snarling is inevitable above this limit, even when the yarn is held taut. This theoretical onset of snarling may have useful applications in the analysis of the twisted zone in false-twist bulking processes, where the highest twist is used and temporary snarling is intentionally induced. In the second part, the geometry of primary cording, i.e., the twisting together of two or more twisted yarns, is investigated with the approximation of neglecting their curvature whilst taking proper account of their true length and true torsion. This approximation allows the results of the first part of the paper to be applied and leads to a fairly simple solution without need to consider the path of individual filaments. The resultant equations show that there is a cord twist at which the “de-twist” (more accurately, reduction of torsion) of the plies is a maximum: further increase of cord twist beyond this level increases ply torsion towards the pre-twisted level. This explains the minimum found experimentally when outside filament-angle relative to the ply axis is plotted against cord twist. In the third part, the existence of a limit to cord twist is demonstrated, above which snarling must occur. This is when the plies in the cord are corded as close together as possible, very similar to a close-coiled spring, and though it seems likely that the existence of this limit must be known, at least experimentally to some, yet there appears to be no mention of it in the literature.
Sutures are transient implant, sterile fibers used to close wounds and provide strength during the wound-healing process. In ancient periods, metal wires and natural fibers were used for this purpose. Later on, synthetic fibers like polyamides, polyesters, polypropylene, etc., which are more compatible to human tissues, were introduced. These suture materials are biostable and retain their strength for several years. After successful wound healing, the suture has to be removed in a separate operation. The use of plain catgut, a collagen-based material of natural origin, as an absorbable suture was described as early as 175 A. D. [1, 2]. As the name implies, absorbable sutures degrade in the body environment and lose their strength within a few months. In 1966, polylactic acid (PLA) was found to be an absorbable, nontoxic, and nonirritating synthetic material useful for surgical applications [3]. This led to introduction of the polymer of glycolic acid and its copolymer with lactic acid as successful materials for absorbable sutures [4–6]. Recent studies have shown that polydioxanone [7] and polytrimethylene carbonate [8] are also promising materials for absorbable sutures.
Yarn geometry, when the number of constituent filaments is small, is studied here with particular reference to yarn configuration, retraction, diameter, and packing factor. It is shown how, for twist factors within the range 20–40, yarn configuration and therefore yarn diameter remain more or less constant. A new approach to the definition of yarn diameter is put forward and corroborated by experimental evidence. A new formula for yarn retraction on twisting is determined for yarns having filament numbers in the range 1–37, and experimental evidence is given to show how it is more applicable than Treloar's formula when the number of filaments is fewer than 37. Two new definitions of packing factor are considered.
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 performance of suture materials. This review proposes to bring to focus scattered data on chemistry, properties, biodegradability, and performance of absorbable polymeric sutures.
Flexor tendons should be repaired with suture material strong enough to permit early motion and small enough for the resulting knot to allow unimpeded tendon glide and healing. This study sought to define differences in cross-sectional area and knotted tensile strength among Fiberwire, Prolene, and Ticron sutures.
Five strands, each of 3-0 and 4-0 Prolene, Ticron, and Fiberwire sutures, were embedded in polymethylmethacrylate and sectioned in a linear precision saw to obtain 10 cross-sections of each material and size. These were examined by scanning electron microscopy and digitally analyzed for cross-sectional areas. Ten strands of each suture material and size had a single throw knot placed, and they were loaded to failure in a micromechanical tester.
Prolene and Ticron cross-sections were circular. Fiberwire was noncircular. The 3-0 Fiberwire sutures had greater cross-sectional area than the 3-0 Ticron sutures (p < .001), which in turn were larger than 3-0 Prolene (p < .05). The 4-0 Fiberwire cross-sectional area was also greater than that of 3-0 Ticron and Prolene (p < .05). After relating knotted tensile strength to cross-sectional area, Fiberwire was 10% stronger than Prolene, and 25% stronger than Ticron.
Fiberwire is not only stronger, but also larger than other sutures in the same or even higher suture size category. Failure to meet the United States Pharmacopeia standards for suture diameter is declared in the product information sheet, although surgeons may not be aware of these size variations. Suture size definitions are currently based on diameter, a consistent measure for circular monofilament sutures, but not for braided or noncircular sutures.
Suture application varies for different tissues, different patients, and different circumstances. The large array of new sutures, staples, tapes, and topical adhesives can make the proper choice for closure a challenge. This review of the available materials for skin closure, and their biomechanical properties, advantages, and disadvantages, creates a structure for better understanding of the limitations, indications, and numerous choices to be considered before choosing a suture material.
The ideal suture is strong, handles easily, and forms secure knots. It causes minimal tissue inflammation and does not promote infection. It stretches and accommodates wound edema. Although no single suture possesses all of these features, proper selection of sutures helps achieve better results in skin surgery. 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.
The tensile properties of three new sutures, two non-absorbable and one absorbable material, have been evaluated and compared with those of polypropylene and nylon sutures. It was found that the five materials differed significantly in their tensile strengths and elastic/plastic deformation characteristics but displayed comparable elongations at failure. All sutures showed a decrease in failure load and elongation at failure when knotted. Most materials showed an increased tensile strength and decreased elongation at failure for smaller suture gauges, and this behaviour is thought to be related to their internal molecular organization.
Selection of wound closure materials (sutures, needles, staples, and skin tapes) is presented. The characteristics of commonly used suture materials and needles are discussed as a background for their rational selection and usage. The attributes of staples and sutureless skin closures (skin tapes) are also given and contrasted with those of sutures.
Tensile strength of poly(glycolic acid) suture (PGA) of size 2-0 was examined as a function of three pH levels, 5.25, 7.44, and 10.09 of the buffer. Cord and yarn grip was used to eliminate grip-induced failure of breaking strength tests. It was found that Dexon sutures degraded significantly faster in pH = 10.09 buffer than the other two lower pH buffers. There was no significant difference in degradation rate at pH = 5.25 and 7.44. At 7 days, PGA sutures lost almost half of its original tensile strength at pH = 10.09, while the same sutures still remained more than 95% of their original breaking strength at buffers of pH = 5.25 and 7.44. After 21 days, no trace of sutures could be detected in the buffer of pH = 10.09 while about 20% strength still remained in the buffers of pH = 7.44 and 5.25. Cage effect in the crystalline phase and pH dependent hydrogen bonding were introduced to explain the difference in degradation phenomenon of PGA at buffers of various pH.
The tensile strengths of poly(glycolic acid) (PGA) sutures immersed in buffered and unbuffered aqueous media were compared. The media used were an unbuffered physiological saline solution (pH = 5.0) and a phosphate-buffered physiological saline solution (pH = 7.4). PGA samples were immersed for various periods in each medium, and kept at 37 +/- 1 degree C in a constant temperature oven. The tensile strengths of the specimens were tested immediately after removal from the medium. Stress-strain curves of the specimens were expressed in terms of the stress unit "tenacity," commonly used in the study of fibrous polymers; it is an appropriate unit for materials of fibrous nature. These stress-strain curves were investigated as functions of buffering and duration of immersion. Degradation reduced the tensile strength of PGA more in the buffered saline solution than in the unbuffered. This higher rate of degradation in the buffered solution might be due to the presence of Na2HPO4, which removed the degradation products, shifted the reaction toward increased hydrolosis, and accelerated the loss of tensile strength in the PGA. A continuous decrease in the pH of the unbuffered solution supports this explanation. Tied-chain segments of macromolecules, a theory widely used in the study of mechanical strength of fibrous polymer may be the key to a comprehensive description of the degradation phenomenon of PGA.
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