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At least 19 recordsLinked to original sources
PubMed2006

Impact of chromic catgut versus polyglactin 910 versus fast-absorbing polyglactin 910 sutures for perineal repair: a randomized, controlled trial.

OBJECTIVE: The goal of our study was to compare the impact of 3 suture materials on perineal pain and on resumption of sexual intercourse. STUDY DESIGN: This randomized, controlled trial compared 3 types of suture materials (chromic catgut, polyglactin 910, fast-absorbing polyglactin 910) for second-degree perineal laceration or uncomplicated episiotomy. Patients were enrolled in early labor and assigned randomly to 1 of the 3 suture materials. Pain was evaluated at 48 hours, 6 weeks, and 3 months. The study subjects were questioned about residual perineal pain, resumption of sexual activity, and pain-free sexual intercourse. Logistic regression analyses were undertaken. RESULTS: Of the 192 patients who were assigned randomly to groups, 66 patients had their perineal laceration repaired with chromic catgut; 60 patients had repair with polyglactin 910, and 66 patients had repair with fast-absorbing polyglactin 910. At 48 hours, there was no significant difference according to the pain measurement scores, but the median consumption of analgesics was significantly lower with fast-absorbing polyglactin 910 than with standard polyglactin 910. There was no difference in the resumption of sexual intercourse at 6 weeks after the delivery between chromic catgut (42%) compared with standard polyglactin 910 group (56%; P = .23). However, it was more frequent for women in the fast-absorbing polyglactin 910 group (66%; P = .02). After adjustment for confounding variables, perineal repair with fast-absorbing polyglactin 910 was associated with a higher rate of sexual intercourse (odds ratio, 2.55; 95% CI, 1.07-6.10) and a higher rate of pain-free sexual intercourse (odds ratio, 2.51; 95% CI, 1.03-6.10) at 6 weeks after delivery. CONCLUSION: Fast-absorbing polyglactin 910 for perineal repair is associated with earlier resumption of sexual intercourse when compared with chromic catgut.

Absorption↗
PubMed2005

Intraoperative handling and wound healing: controlled clinical trial comparing coated VICRYL plus antibacterial suture (coated polyglactin 910 suture with triclosan) with coated VICRYL suture (coated polyglactin 910 suture).

BACKGROUND: Coated polyglactin 910 suture with triclosan was developed recently in order to imbue the parent suture, coated polyglactin 910, with antibacterial activity against the most common organisms that cause surgical site infections (SSI). Because such alterations could alter the physical properties of the suture, this study sought to compare the intraoperative handling and wound healing characteristics of coated polyglactin 910 suture with triclosan and traditional coated polyglactin 910 suture in pediatric patients undergoing various general surgical procedures. METHODS: This was a prospective, randomized, controlled, open-label, comparative, single-center study. Pediatric patients (age 1-18 years) undergoing various surgical procedures were randomized in a 2:1 ratio to treatment with either coated polyglactin 910 suture with triclosan or coated polyglactin 910 suture. The primary endpoint was the surgeon's assessment of the overall intraoperative handling of coated polyglactin 910 suture with triclosan and traditional coated polyglactin 910 suture without triclosan. The secondary endpoints included specific intraoperative suture handling measures and wound healing assessments. The suture handling measures were (1) ease of passage through tissue; (2) first-throw knot holding; (3) knot tie-down smoothness; (4) knot security; (5) surgical handling; (6) surgical hand; (7) memory; and (8) suture fraying. Assessment of wound healing included the following: Healing progress, infection, edema, erythema, skin temperature, seroma, suture sinus, and pain. Adverse events were recorded. RESULTS: Scores for intraoperative handling were favorable and not significantly different for both sutures, although coated polyglactin 910 suture with triclosan received more "excellent" scores (71% vs. 59%). Wound healing characteristics were comparable for both sutures except for pain on postoperative day 1. Significantly fewer patients treated with polyglactin 910 suture with triclosan reported pain on day 1 than patients who received the other suture (68% vs. 89%, p = 0.01). The overall incidence of adverse events was 18%; none was devicerelated. CONCLUSIONS: Coated polyglactin 910 suture with triclosan performed as well or better than traditional coated polyglactin 910 suture in pediatric patients undergoing general surgical procedures. The incidence of postoperative pain was significantly less in patients treated with coated polyglactin 910 suture with triclosan than the traditional suture. We speculate that polyglactin 910 suture with triclosan, by inhibiting bacterial colonization of the suture, reduced pain that can be an indicator of "subclinical" infection. Coated polyglactin 910 suture with triclosan may be a useful alternative in patients at increased risk of developing SSI.

Adolescent↗
PubMed2002

Physical and functional comparison of Coated VICRYL* Plus Antibacterial Suture (coated polyglactin 910 suture with triclosan) with Coated VICRYL* Suture (coated polyglactin 910 suture).

BACKGROUND: The goal of this study was to compare the physical and functional properties of coated polyglactin 910 suture with and without triclosan by human assessment and instrument-based measurements. METHODS: Surgeons specializing in general, orthopedic, plastic, or gynecologic surgery evaluated the suture materials in an in vivo porcine model with regard to (1) ease of passage through tissue, (2) first-throw knot holding, (3) knot tie-down smoothness, (4) knot security, (5) surgical handling, and (6) overall evaluation. Breaking strength retention was determined at 14, 21, 28, and 35 days post-implantation in rats using a tensile strength measurement device. The absorption rate was determined in rats by histopathology at 7, 28, 56, 63, 70, and 77 days post-implantation. The tactile smoothness and tie-down behavior of both wet and dry sutures were evaluated by product characterization technicians. RESULTS: The scores for surgeons' evaluation of suture material were favorable and similar for both sutures. Surgeons could not reliably make a distinction in handling between the two sutures. Breaking strength retention was the same for both sutures, ranging from 79% on day 14 to 5% on day 35. Both sutures were essentially absorbed at 70 days post-implantation. Product characterization assessment of the two sutures found them to be indistinguishable. CONCLUSION: The addition of triclosan to coated polyglactin 910 sutures did not affect physical handling properties or performance characteristics based on the testing and evaluations performed.

Animals↗
PubMedDate not supplied

The effect of a penetrating biodegradable implant on the epiphyseal plate: an experimental study on growing rabbits with special regard to polyglactin 910.

A polyglactin 910 rod 3.2 mm in diameter and 25 mm in length was driven in a drill hole in the intercondylar portion of the right femur across the central portion of the growth plate in 20 5-week-old rabbits. The follow-up times were 3, 6, 12, and 24 weeks. The distal femoral growth plates of both femurs were analyzed by radiographic, microradiographic, and oxytetracycline fluorescence, histological, and histomorphometric studies. Histomorphometric studies showed clear changes at injury site and appeared to be an excellent means of exact numerical description of the different cellular areas of the growth plate. Six weeks after implantation, a polyglactin 910 implant resulted in a growth disturbance similar to that of a drill hole of equal bore.

Animals↗
PubMed2002

Use of 7/0 Vicryl (coated polyglactin 910) and 7/0 Vicryl-rapide (irradiated polyglactin 910) in skin closure in ophthalmic plastic surgery.

AIMS: To assess the safety and efficacy of 7/0 Vicryl and 7/0 Vicryl rapide sutures for skin closure, and without suture removal, in ophthalmic plastic surgery. METHOD: A prospective, comparative study of 40 consecutive procedures in 32 patients. Tissue reactions to the sutures, completeness of wound healing, and number of sutures remaining were observed at first dressing, 2 weeks and 2 months. RESULTS: Wound healing was excellent at 2 weeks in all but one Vicryl rapide patient whose slight wound gape was not attributable to the suture material used. No inflammatory tissue reaction attributable to the suture was seen. No visible suture marks were observed at 2 months. Transient crusting was observed around the sutures in 9/20 (45%) and 10/20 (50%) patients with Vicryl and Vicryl rapide, respectively. Only one suture out of 144 was removed. CONCLUSION: 7-0 Vicryl and 7-0 Vicryl rapide are safe and effective sutures for skin closure in ophthalmic plastic surgery.

Adult↗
PubMed1979

Arterial regeneration following polyglactin 910 suture mesh grafting.

A suture mesh of polyglactin 910 [Vicryl (polyglactin 910) suture mesh] was placed as a patch graft into the thoracic aorta of 23 growing pigs. In three other pigs the mesh was grafted in the form of a tube to replace a short aortic defect. The biological processes taking place in the grafted area were studied by morphological methods. The following observations were made: (1) Hemostasis readily occurred by fibrin, platelet, and erythrocyte embedding of the mesh. (2) Early outgrowth of smooth muscle cells around the mesh took place from the normal aortic media and from a newly formed subintimal smooth muscle layer. (3) The newly formed arterial tissue was completely endothelialized within 20 days. (4) The polyglactin mesh had disappeared almost completely at 40 days, but the new wall seemed to retain sufficient strength throughout the observation time. (5) Only irregular deposition of elastic fibrils occurred, but in other respects the new tissue structurally resembled normal arterial tissue.

Animals↗
PubMed1998

The Ipswich Childbirth Study: 2. A randomised comparison of polyglactin 910 with chromic catgut for postpartum perineal repair.

OBJECTIVE: To compare polyglactin 910 sutures with chromic catgut sutures for postpartum perineal repair. DESIGN: A stratified randomised controlled trial, using a 2 x 2 factorial design. SETTING: The maternity unit at Ipswich Hospital NHS Trust, a district general hospital, between 1992 and 1994. SAMPLE: 1780 women who had sustained an episiotomy or first or second degree tear following a spontaneous or simple instrumental delivery. METHODS: Policies of repair with polyglactin 910 or chromic catgut were compared. Both groups were assessed by a research midwife completing questionnaires at 24 to 48 hours and at ten days postpartum, and by self-completed questionnaires at three months after birth. MAIN OUTCOME MEASURES: 1. 24 to 48 hours postpartum: perineal pain, healing; 2. ten days postpartum: perineal pain, healing and removal of sutures; 3. three months postpartum: perineal pain, removal of sutures, resuturing, dyspareunia, and failure to resume pain-free intercourse. RESULTS: Completed questionnaires were returned for 99% of women at both 24 to 48 hours and ten days and by 93% of women three months postpartum. The two groups were similar at trial entry. Significantly fewer women allocated to the polyglactin 910 reported pain in the previous 24 hours at both 24 to 48 hours (59% vs 67%; RR 0.89, 95% CI 0.83-0.95; 2P < 0.01), and ten days (24% vs 29%; RR 0.81, 95% CI 0.69-0.95; 2P = 0.01). At three months postpartum there was no clear difference between the groups in terms of perineal pain, dyspareunia or failure to resume pain-free intercourse. More women in the polyglactin 910 group reported that some suture material had been removed (12% vs 7%; RR 1.62, 95% CI 1.19-2.21; 2P < 0.01). Three women in the polyglactin 910 group had required resuturing compared with ten in the chromic catgut group (RR 0.30; 95% CI 0.08-1.09; 2P = 0.1). CONCLUSIONS: Using polyglactin 910 rather than chromic catgut for perineal repair leads to about one fewer women among every 20 having perineal pain and using analgesia ten days postpartum. Its only apparent disadvantage is that more women, again estimated as 1 in 20, report having material removed during healing. Data from this and other trials suggest that for every 100 women repaired with a polyglycolic acid-based material, about one fewer will require resuturing.

Adult↗
PubMed1975

The evaluation of 7-0 Polyglactin 910 suture in cataract surgery.

The new synthetic absorbable suture, Polyglactin 910, represents a significant step toward absorbable suture perfection. In 218 cataract surgical procedures, the performance of Polyglactin 910 was compared to that of Chromic Catgut and Chromic Collagen. The results obtained in this series of cases is the basis for this article. When compared to Chromic Catgut and Chromic Collagen, Polyglactin 910 consistently provided greater tensile strength, improved handling, significantly decreased tissue reaction, more batch-to-batch uniformity, superior wound tensile strength retention, and a predictable absorption rate that is virtually completed in 35 days. Both nonprotein and nonantigenic, Polyglactin 910 evoked less tissue reaction and proved more versatile and reliable than either of the other sutures.

Absorption↗
PubMed1976

An evaluation of 8-0 Polyglactin 910 synthetic absorbable suture in cataract surgery.

This study describes the operative and postoperative performance of 8-0 Polyglactin 910 in cataract surgery. The evaluation represents a clinical comparison of 7-0 Polyglactin 910 to the same suture in 8-0 size in 155 cataract surgical procedures. In 45 cases, 8-0 Polyglactin 910 was the sole wound closure material used. 8-0 Polyglactin 910 provided high tensile strength, good knot security, batch-to-batch uniformity, ease of handling, minimal reaction, and a predictable absorption rate that was virtually completed in 33 days. When compared to 7-0 Polyglactin 910, 8-0 produced less tissue drag, fibrillation, and reaction. Early in our series, three cases of wound dehiscence occurred. One was caused by trauma and the other two by 8-0 Polyglactin 910 cutting through tissue. This study's conclusion stresses avoiding the tendency of tying the knot too tightly to prevent suture pull-out.

Absorption↗
PubMed1977

Experiences with polyglactin 910 (Vicryl) in general surgery.

The physical properties of polyglactin 910 (Vicryl) have been studied experimentally and clinically and compared with other synthetic and natural suture materials. Polyglactin 910 has a relatively high fluid absorption capacity but a low capillary capacity. The tensile strength is high and well comparable with, or superior, to other synthetic non-absorbable suture materials commonly used. The elongation at break is moderate. No unfavourable wound reaction to the suture material has been registered. The material has not increased the expected frequency of wound infections. The follow up of laparotomized patients 12-18 months after the operation showed a very low frequency of wound hernia. Neither was any recurrence noticed after repair of inguinal hernia. No clinical signs of leakage in the anastomoses of the gastrointestinal region was registrated. It is concluded that polyglactin 910 in a wide extent seems to be able to replace catgut and also non-absorbable suture materials when normal wound healing is to be expected.

Absorption↗
PubMed1977

Polyglactin 910 suture in urinary tract.

Cystotomies in guinea pigs and ureteral anastomoses in dogs were sutured with polyglactin 910. Silk and chromic catgut were used as control sutures in the bladders and chromic catgut in the ureters. Three months postoperatively in bladders sutured with polyglactin 910 small epithelial cysts were noted, which increased in size with time. In ureters sutured with polyglactin 910 cystic diverticula were observed eight months postoperatively. Because of the difference of tissue reaction to polyglactin 910 compared with catgut, further long-term studies are urged in different species of animals, prior to the clinical use of polyglactin 910 in the urinary tract.

Animals↗
PubMed2002

In vitro antimicrobial evaluation of Coated VICRYL* Plus Antibacterial Suture (coated polyglactin 910 with triclosan) using zone of inhibition assays.

BACKGROUND: In this study, coated polyglactin 910 suture with triclosan was evaluated for its ability to inhibit the growth of wild-type and methicillin-resistant Staphylococcus aureus and S. epidermidis using several in vitro models. METHODS: In the standard experimental procedure, sterile sutures were inoculated with bacteria, plated in semisolid culture media, incubated for 24 h, and examined for zones of inhibition surrounding the sutures. Sutures were pretreated by several methods prior to inoculation, these included: 24-h aqueous immersion, serial 7-day aqueous immersion, knotting, and passage through subcutaneous and fascial tissue. Sutures were also compared to determine if suture diameter had an effect on the zone of inhibition. RESULTS: Coated polyglactin 910 suture with triclosan inhibited growth of test organisms consistently over a range of suture diameters and treatment conditions. The antibacterial effect was robust and did not diminish when sutures were placed in an aqueous environment for up to 7 days. Knotted suture with triclosan inhibited bacterial colonization after replicate inoculation. The bacteria-free zone surrounding each knotted suture had a volume of 14.5 cm(3) for S. epidermidis and 17.8 cm(3) for S. aureus. Coated polyglactin 910 suture with triclosan continued to produce zones of inhibition after five and 10 passes through fascia and subcutaneous tissue. CONCLUSION: These data support the conclusion that coated polyglactin 910 suture with triclosan provides antimicrobial effect sufficient to prevent in vitro colonization by S. aureus and S. epidermidis.

Anti-Infective Agents, Local↗
PubMed1980

Comparative evaluation of coated and uncoated polyglactin 910 in cataract and muscle surgery.

This study describes the intraoperative and postoperative performance of coated and uncoated Polyglactin 910 in cataract and muscle surgery. The evaluation represents an animal and clinical comparison of 5-0 coated and uncoated Polyglactin 910 in 50 muscle cases and 7-0 coated and uncoated Polyglactin 910 in 150 cataract cases. Both Polyglactin 910 sutures provided high tensile strength, good knot security, batch-to-batch uniformity, ease of handling, minimal reaction, and a predictable absorption rate. Improvements noted in the coated suture were: (1) easier passage through tissue, (2) less chatter in tying, (3) fewer instances of premature tie, and (4) decreased tendency to incarcerate tissue.

Absorption↗
PubMed2002

Chemistry and safety of triclosan, and its use as an antimicrobial coating on Coated VICRYL* Plus Antibacterial Suture (coated polyglactin 910 suture with triclosan).

BACKGROUND: The safety of the antimicrobial agent triclosan was reviewed, and the biocompatibility of coated polyglactin 910 suture with triclosan was evaluated. METHODS: Acute single exposure LD(50) values for triclosan were determined in multiple species by several routes of administration. Subacute to chronic toxicity for dermal and oral exposure to triclosan was determined in multiple species in studies of up to one year's duration. Chronic oral toxicity/carcinogenicity potential was determined in 2-year studies in rodents and non-rodents. The genotoxicity potential of triclosan was determined using a battery of standard assays. Reproductive toxicity and teratology studies were conducted in rodents and non-rodents. Immunotoxicity studies in guinea pigs and the repeat-insult patch test in humans were conducted to assess the potential for sensitization reactions. Pharmacokinetic studies were conducted in animals and humans to understand the metabolic profile of triclosan. Preclinical biocompatibility studies conducted on coated polyglactin 910 suture with triclosan included in vitro cytotoxicity, in vivo intracutaneous reactivity, material-mediated pyrogenicity, and intramuscular tissue reaction/absorption studies. RESULTS: The oral LD(50) values for triclosan ranged from 3,750 to 5,000 mg/kg, whereas the LD(50) after subcutaneous injection was >14,600 mg/kg. Safety factors calculated from repeated daily dosing studies ranged from 1,000 to 25,000 times the no-observed-effect levels. There was no evidence of carcinogenic potential in either species, and genotoxicity studies were negative. Reproductive toxicity studies did not reveal any evidence of teratogenic potential. There was no evidence of skin sensitization potential in controlled studies. Pharmacokinetic studies in animals and humans have shown that triclosan is rapidly absorbed, well distributed in the body, metabolized in the liver, and excreted by the kidneys, with no indication of accumulation over time. Biocompatibility studies showed that coated polyglactin 910 suture with triclosan was non-cytotoxic, non-irritating, and not a chemical pyrogen. In addition, an intramuscular implantation study demonstrated a tissue reaction, a healing response, and an absorption profile comparable to current polyglactin 910 suture. CONCLUSION: The extensive toxicology database supporting the safety of triclosan and the biocompatibility studies conducted on coated polyglactin 910 suture with triclosan demonstrate the safety of this suture for clinical use. Considering the clinical relevance of surgical site infections and the relatively low level of triclosan required to inhibit bacterial colonization of the suture, the use of this antimicrobial technology is well suited to this application.

Animals↗
PubMed2004

Randomized comparison of chromic versus fast-absorbing polyglactin 910 for postpartum perineal repair.

OBJECTIVE: We conducted a randomized trial to evaluate the healing characteristics of chromic versus fast-absorbing polyglactin 910. METHODS: Laboring women were randomly assigned to chromic or fast-absorbing polyglactin for perineal repairs. Subjects were evaluated at 24-48 hours, 10-14 days, and 6-8 weeks to assess perineal and uterine pain, analgesic use, presence of residual suture, and wound dehiscence. RESULTS: Between April 2002 and January 2003, 1,361 subjects were randomly assigned. Two thirds of women in each group (459 fast-absorbing polyglactin and 449 chromic) required sutures for perineal repairs. Women were evaluated according to randomization assignment. Overall, 794 (87%) of subjects received the appropriate allocated suture to repair a perineal laceration (399 of 459, 86.9% fast-absorbing polyglactin 910; 395 of 449, 88% chromic catgut). At 24-48 hours, there was a statistically significant reduction in uterine cramping pain (25% versus 34%; P =.006) in subjects randomly assigned to fast-absorbing polyglactin. At 10-14 days, there were no statistically significant differences between the groups. At 6-8 weeks there was, again, a statistically significant reduction in uterine cramping pain (1% versus 4%; P =.017) and a statistically significant decrease in analgesic use (5% versus 10%; P =.048) in subjects randomly assigned to fast-absorbing polyglactin. Finally, at 6-8 weeks postpartum there was no difference in residual suture (2 of 175 versus 2 of 134; P =.802) or wound breakdowns (4 of 175 versus 3 of 134; P =.959) for fast-absorbing polyglactin 910 and chromic catgut, respectively. CONCLUSION: Our data suggest that fast-absorbing polyglactin 910 and chromic elicit similar postpartum perineal discomfort. In contrast to previous studies evaluating standard polyglactin, our trial demonstrated that fast-absorbing polyglactin rarely requires late removal and has a similar wound breakdown profile as compared with chromic. LEVEL OF EVIDENCE: I

Catgut↗
PubMed1975

The use of Polyglactin 910 in muscle surgery.

This study represents the clinical evaluation of a newly developed snythetic absorbable suture, Polyglactin 910, in 5-0 and 6-0 sizes as used in muscle surgery. In 240 cases, Polyglactin 910 has spoken very well for itself. It possesses extremely high tensile strength and wound tensile strength retention, excellent handling characteristics and a predictable absorption rate, while the amount of tissue reaction it produces is consistently less than that of comparably sized sutures of Chromic Catgut. Polyglactin 910 is both versatile and reliable, and reflects important progress toward the development of "the perfect" absorbable suture. This article details Polyglactin 910's shortcomings as well as its strong points, and provides a recommended handling technique for its use.

Absorption↗
PubMedDate not supplied

Bone formation with discs or particles of natural coral skeleton plus polyglactin 910 mesh: histologic evaluation in rat calvaria.

Several procedures have been used to regenerate localized bone defects around dental implants or to increase bone volume at an implant site, including bone grafting, placement of barrier membranes, and use of bone graft substitutes. This study sought to determine whether the bone graft substitute natural coral skeleton (NCS), with or without a protective polymer mesh, enhances bone formation in rat critical size craniotomy defects. The control group (1) had unfilled defects, while the defects in the four experimental groups (six rats each) were treated with: (2) an NCS disc of the size of the defect; (3) NCS granules; (4) NCS granules covered by a polyglactin 910 mesh; and (5) polyglactin 910 mesh alone. Undecalcified histologic sections were assessed by histomorphometric measurements 28 days later. The three NCS groups showed improved bone formation, which was statistically significant in groups (2) (NCS disc) and (4) (NCS granules covered by polyglactin 910 mesh). Group 4 had more bone formation than all the other groups. Polyglactin 910 mesh alone (group 5) produced no greater bone formation than the unfilled control. It is concluded that the bone formation obtained with NCS granules is enhanced when the particles are retained at the site of the defect with a protective mesh.

Animals↗
PubMed1996

Comparison of polydioxanone and polyglactin 910 in intradermal repair.

A prospective clinical study was undertaken to compare the results of intradermal layer closure using two popular absorbable suture materials, polydioxanone and polyglactin 910. On an alternating basis, 6-0 polydioxanone and 6-0 polyglactin 910 were used to repair 80 surgical sites of the temple and occipital regions in 20 patients undergoing facial rhytidectomy. In all instances, the superficial skin layer was repaired with 6-0 plain catgut. These sites were evaluated by a double-blind method for erythema, induration, infection, scar spread, and hypertrophic scarring at approximately 5 months and at least 1 year postoperatively. Scar spread was indicated at widths greater than 1 mm. Any raised scar was labeled hypertrophic. Scar spread, as defined above, was observed in 6 of 38 incisions repaired with polyglactin 910, and 3 sites developed scar hypertrophy. Conversely, 3 of 38 incisions closed with polydioxanone revealed scar spread (p < 0.25), and 3 were hypertrophic (p < 0.35). Sixty-one sites healed with undiscernible scars. This study does not disclose any statistically significant difference in the quality of the scars when polyglactin 910 is used compared with polydioxanone.

Cicatrix↗