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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

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

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

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

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

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

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

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

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

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

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

[Barraquer-silk (8 x 0) and polyglactin 910 (8 x 0) in corneo-scleral incisions of rabbit eyes. A histological study].

Barraquer-silk (8 x 0) and Polyglactin 910 (8 x 0) were histologically examined in corneo-scleral incisions of rabbit eyes. Wound healing using both suture materials was complete after two weeks, as observed by light microscopy. Barraquer-silk excited more cellular reaction than Polyglactin 910. Absorption of Polyglactin 910 suture began 18 days after surgery whilst Barraquer-silk did not begin to absorb until 42 days had passed.

Animals

Basic fibroblast growth factor production in vitro by macrophages exposed to Dacron and polyglactin 910.

Macrophage activation by implanted blood-contacting biomaterials modulates smooth muscle cell and endothelial cell ingrowth. The present study evaluates the in vitro interactions between Dacron or polyglactin 910 with macrophages derived from rabbits fed either normal or atherogenic diets. Peritoneal macrophages were cultured in the presence or absence (negative controls) of either biomaterial for 7 weeks. Conditioned media was evaluated for mitogenic activity using a rabbit aortic smooth muscle cell bioassay with or without preincubation with neutralizing anti-basic-FGF antibody. Results demonstrated increased mitogen release from macrophages harvested from the atherosclerotic rabbits. Only macrophages harvested from normal diet fed rabbits increased their mitogen release following exposure to either polyglactin 910 (p < 0.05) or to Dacron (p < 0.005) over controls. The stimulation of mitogen release by polyglactin 910 did not significantly exceed that in response to Dacron. In rabbits fed normal diets neutralization with the anti-basic-FGF antibody inhibited 100% of the Dacron induced mitogen release as compared to 36% of the polyglactin 910 induced mitogen release (p < 0.01). These results demonstrate significant induced mitogen release from macrophages exposed to biomaterials in vitro, much of the smooth muscle cell mitogen represented by basic-FGF.

Animals

Mechanical performance of polyglycolic acid and polyglactin 910 synthetic absorbable sutures.

The mechanical performance of polyglycolic acid and polyglactin 910 sutures has been assessed using standardized reproducible tests. The results of these studies demonstrated distinct differences in their performance that can be related, in part, to their structural configuration. The size of the 4-0 polyglactin suture was significantly larger than that of the 4-0 polyglycolic acid suture. Since the strength of any suture is proportional to its cross sectional area, the strength of unknotted and knotted polyglactin 910 sutures was signficantly greater than that of the polyglycolic acid sutures. The strength of both sutures was similarly diminished by the formation of the knot. When these sutures were added to tissue, the breaking strength was even further reduced. The rate of decline in breaking strength of the two absorbable sutures in healing skin wounds was comparable. These absorbable sutures displayed knot security with a two throw square knot, 1 = 1. The ability of these sutures to reach knot break with this knot configuration is characteristic of sutures in which the surface exhibits a high coefficient of friction. Their rough surface also caused them to drag through tissue, making difficult to adjust tension on a continuous running suture.

Absorption

A new aneurysm wrapping material: polyglactin 910 + fibrin sealant.

Aneurysms experimentally induced by using the silver nitrate coagulation method in 10 Wistar Albino rats are wrapped with Polyglactin 910 and Fibrin Sealant. 6 weeks later the rats are sacrificed and compared with the control group. In the group in which Polyglactin 910 and Fibrin Sealant were used as the wrapping material, non-specific inflammatory granulation tissue development around the aneurysms is observed. We suggest that a Polyglactin 910 and Fibrin Sealant combination can be used as a wrapping material in the treatment of aneurysms where clipping is not possible.

Animals

Reconstruction of orbital wall fenestrations with polyglactin 910 film.

Medial orbital wall fenestrations were created bilaterally in 16 adult cats. The fenestrations were reconstructed with polyglactin 910 film, Dacron-reinforced silicone sheeting, or no implant. Polyglactin 910 was found to be well tolerated in this traumatized area of paranasal sinus bone and soft tissue and was totally absorbed in 4 months. Dacron-reinforced silicone sheeting induced a long-standing acute inflammatory reaction in a similar milieu. Partial osseus replacement of the orbital fenestrations occurred in all animals, but it was accompanied by distortion and erosion in apposition to the silicone sheeting. The study does not answer the question of whether orbital contour will be maintained on a long-term basis adjacent to a pneumatized sinus following reconstruction with a bioabsorbable implant.

Animals

[Anastomoses of the small intestine in a septic environment protected by polyglactin 910-collagen mesh. Experimental study in rats].

An experimental study was carried out in rats to evaluate the outcome of small bowel anastomoses in the presence of peritonitis with and without protection by a polyglactin 910 mesh. One hundred and thirty rats were operated. 1) Thirty small bowel anastomoses were performed in a sterile environment to evaluate the morbidity and mortality due to the surgical procedure itself. All these animals had an uneventful course. 2) Forty anastomoses were performed in a septic environment without protection. Twelve rats died immediately after the procedure. Six rats developed an anastomotic fistula and 22 had an uneventful course. 3) Sixty anastomoses were performed in a septic environment and protected by a polyglactin 910 mesh. Seventeen rats died immediately after the procedure. There were no anastomotic disruptions. Seventeen rats had an uneventful course, and 28 (65%) developed stenosis of the anastomosis. Protection of small bowel anastomoses by a polyglactin 910 mesh appears to effectively prevent disruptions (no anastomotic fistulae or locoregional infections were recorded). However, the mesh is responsible for an intense inflammatory reaction, that often results in intestinal obstruction.

Anastomosis, Surgical

Polyglactin 910 suture absorption and the role of cellular enzymes.

Enzyme histochemical procedures for both hydrolase and oxidoreductase enzyme activity were applied to cryostat sections of polyglactin 910 suture implant sites. Sutures were implanted either solely in tissue or in a combination of in vitro incubation followed by implantation in vivo for total time periods of seven to 56 days. Suture absorption rates were also measured. It is concluded from the results that neither cellular nor enzyme activity is necessary for the degradation and absorption of polyglactin 910 sutures. This conclusion is based on similar absorption rates for sutures implanted solely in vivo and sutures treated in vitro and then implanted in tissue to give equivalent time spans. There were strong indications, however, that the products of suture hydrolysis are probably metabolized through the oxidative enzyme systems of cells adjacent to the suture. This mechanism of polyglactin 910 suture absorption is quite different from that observed and reported for catgut absorbable sutures.

Absorption