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[Results of a controlled trial comparing 3 suture threads at slow resorption for the closure of supra-umbilical midline laparotomies].

A randomized prospective trial was carried out between September 1987 and February 1989 to compare 3 different absorbable sutures (polyglactine 910, polydioxanone I, polydioxanone II) for closure of the abdominal wall after upper midline laparotomy for elective operations. The technique used to close the fascia was always a continuous suture. The criteria used to assess the results were the development of wound infection and wound dehiscence in the early postoperative period, and the development of suture sinuses and incisional hernia 1 year after operation. The early postoperative results in 235 patients revealed no wound infection and no -wound dehiscence. Suture sinuses developed in 4 patients (2%) 2 months after operation, but resolved spontaneously. We reviewed 203 patients after one year. The total number of incisional hernias detected 1 year postoperatively was 22 cases (11%), (polyglactine 910, 14.2%; polydioxanone I, 11.2%; polydioxanone II, 8.4%). The difference between the 3 groups was not statistically significant. The results of the trial indicate that absorbable sutures have a very low incidence of suture sinuses, and that polydioxanone II seems to be a good choice for closing laparotomies.

Adult↗

A mechanical study of ligature security of commercially available pre-tied ligatures versus hand tied ligatures for use in equine laparoscopy.

OBJECTIVE: To determine a hand-tied ligature knot configuration, suture size, and suture type that would be an acceptable substitute to commercially available ligature knots for use in equine laparoscopic surgery. STUDY DESIGN: Three-factor ANOVA with the fixed effects being suture type, suture size, and knot type. The dependent variable was ligature security (load to failure). METHODS: Commercially available Endoloop and 4 hand-tied slipknot ligatures were compared with a 4-layer square knot. The hand tied ligature knots tested were the 4S modified Roeder knot, the Brooks knot, the modified Roeder knot, and the Weston knot. Two suture sizes (0, 2) of each of 2 suture types (polydioxanone, polyglactin 910) were tested with each hand tied knot. Two types (polydioxanone, polyglactin 910) of size 0 Endoloop were tested. Twenty repetitions of each knot suture type were tested for force to yield on a materials testing machine. Statistical analysis consisted of a 3-way ANOVA with individual comparisons made using the Bonferroni method. Significance was P< or = .05. RESULTS: Only the 4S modified Roeder knot in 2 polydioxanone (103 N) was comparable with the breaking strength of the square knots (157 N). All other knot suture combinations tested were significantly weaker than the square knot (range, 2-18 N). CONCLUSION: For equine laparoscopy, a 2 polydioxanone 4S modified Roeder knot would be an acceptable alternative to the commercially available Endoloop. CLINICAL RELEVANCE: Laparoscopic slip knots are commonly used in equine laparoscopic surgery. Various knot configuration and suture size and type combinations will affect the security of the slip knot.

Analysis of Variance↗

Evaluation of the tensile strengths of four monofilament absorbable suture materials after immersion in canine urine with or without bacteria.

OBJECTIVE: To evaluate the tensile strength, elongation, and degradation of 4 monofilament absorbable suture materials that undergo degradation by hydrolysis in specimens of canine urine with various physical characteristics. SAMPLE POPULATION: 4 monofilament absorbable sutures (polydioxanone, poliglecaprone 25, polyglyconate, and glycomer 631). PROCEDURE: Voided urine was collected from 6 healthy dogs, pooled, filter-sterilized, and prepared to provide 5 media: sterile neutral (pH, 7.0), sterile acidic (pH, 6.2), sterile basic (pH, 8.8), Escherichia coli-inoculated, and Proteus mirabilis-inoculated urine. Ten strands of each suture material were immersed in each of the media for 0 to 28 days. Tensile strength and elongation of each suture material were evaluated by use of a texture analyzer on days 0, 1, 3, 7, 10, 14, 21, and 28. RESULTS: Reduction in tensile strength was detected for all materials in all urine specimens over time. Polyglyconate and polydioxanone had superior tensile strengths in sterile neutral and E. coli-inoculated urine, and polydioxanone retained the greatest tensile strength throughout the study period. All suture materials disintegrated before day 7 in P. mirabilis-inoculated urine. CONCLUSIONS AND CLINICAL RELEVANCE: Polydioxanone, polyglyconate, and glycomer 631 may be acceptable for urinary bladder closure in the presence of sterile neutral and E. coli-contaminated urine. Tensile strength of poliglecaprone 25 in urine may be unacceptable by the critical healing time for bladder tissue (14 to 21 days). During bladder surgery, exposure of suture material that degrades via hydrolysis to urine containing Proteus spp should be minimized.

Animals↗

[Growth of the aortic anastomosis in puppies--comparison of monofilament suture materials, whether absorbable or nonabsorbable, and of suture techniques, whether continuous or interrupted].

This study compared the growth of vascular anastomoses performed with either polypropylene or polydioxanone sutures and with either continuous running suture or interrupted suture technique. Primary end-to-end anastomoses of the infrarenal aorta were performed in 38 puppies. Nineteen were performed with 5-0 polypropylene sutures; in ten all sutures were placed in continuous fashion, and in nine in interrupted fashion. The other nineteen were performed with 5-0 polydioxanone sutures; in ten the sutures were placed in continuous fashion, and in nine in interrupted fashion. The animals were subjected to the repeated aortograms at 2, 4, 8 weeks, 6 months and 1 year following operation. Each abdominal aorta was subjected to burst test, and pathological examination. All anastomoses were patent and tolerated burst-test (300 mmHg). Neither aneurysm nor dilatation of anastomotic site was observed. Anastomotic area was significantly smaller and more stenotic in the continuous polypropylene suture group than in other three groups at 8 weeks, 6 months and 1 year following operation. There was no significant difference among these three groups. No suture materials were observed in the polydioxanone suture groups after 6 months following operation. This study suggests that polydioxanone suture will be useful for the repair of cardiovascular anomalies where growth of the suture line is required.

Absorption↗

Mechanical characteristics of cortical bone pins designed for fracture fixation.

Pins constructed from cortical bone may provide a reasonable alternative to other fracture-fixation devices by circumventing some of the complications associated with stainless steel and synthetic biodegradable implants. However, it is unknown whether cortical bone pins provide comparable strength compared to conventional pins. Using four-point bending, we compared the mechanical characteristics of 1.2-mm allogeneic cortical bone pins milled from specific regions of human tibiae and femora to commercially available 1.1-mm diameter stainless steel pins and 1.3-mm diameter polydioxanone pins. We used impact testing to identify mechanical differences in cortical bone pins between gender and harvest site. Cortical bone pins had better mechanical properties in four-point bending compared with polydioxanone pins, but not stainless steel pins. Pins milled from the right tibiae of males had the best bending characteristics. The mechanical performance of 1.2-mm cortical bone pins was comparable to those of stainless steel and polydioxanone pins regardless of site, bone, and gender. The clinical investigation of cortical bone pins as an implant for fracture fixation is warranted based on mechanical testing and comparison to commercially available polydioxanone and stainless steel pins.

Adolescent↗

Use of absorbable sutures in canine carotid arteries.

To study the functional and microstructural characteristics of polydioxanone sutures in vascular surgery, we created 48 vascular anastomoses in the right and left common carotid arteries of 24 mongrel dogs. In each animal, polydioxanone sutures were used in 1 carotid artery, and polypropylene sutures were used in the contralateral carotid artery. Twelve groups of 2 animals each were then formed. The 1st group was observed for 1 month, the 2nd for 2 months, the 3rd for 3 months, and so on until the 12th group, which was observed for 12 months. At the end of each observation period, reoperation was undertaken to evaluate the vascular anastomoses by means of angiography and microscopy. The polypropylene anastomoses showed a marked deformity, with tissue retraction and a foreign body reaction. In contrast, the polydioxanone anastomoses exhibited satisfactory healing, without deformity, and were well tolerated histologically. We believe that polydioxanone may be a useful, alternative vascular suture material.

Journal Article↗

Histologic effects of different suture materials in microsurgical anastomosis of the rat uterine horn.

OBJECTIVE: To evaluate the histologic effects and permeability rate of different suture materials in microsurgical anastomosis of the left uterine horn in Wistar rats. STUDY DESIGN: In this histologic study, 81 female Wistar rats were used. A transverse section and anastomosis were performed using three surgical techniques. The rats were divided into 15 experimental groups based on evaluation of three variations in microsurgical technique: (1) one-layer transmucosal anastomosis, (2) one-layer extramucosal anastomosis, and (3) two-layer transmucosal anastomosis. With each technique, five suture materials were used: 7/0 polyglycolic acid, 6/0 polyglactin, 7/0 polydioxanone, 7/0 silk and 7/0 polypropylene. RESULTS: The permeability rate was 86%. Polydioxanone persisted in 41% of cases at 90 days. Abnormal proliferation of mucosal epithelium was verified in 10% of cases. Polypropylene was responsible for the majority of foreign-body granulomas. Polydioxanone produced the smallest inflammatory reaction. CONCLUSION: The type of suture material did not influence the permeability rate. Use of nonabsorbable suture material altered the histologic structure the most and produced the greatest tissue reaction. The best results were obtained with polydioxanone. Monofilial sutures gave rise to fewer structural alterations than did multifilament sutures.

Absorption↗

Extraluminal laryngotracheal fixation with absorbable miniplates.

OBJECTIVE: To determine if miniplates made of polydioxanone can be used successfully for extraluminal laryngotracheal fixation. DESIGN: Twelve rabbits underwent anterior and posterior laryngotracheofissure with extraluminal fixation of the divided segments with polydioxanone miniplates. Three control animals did not undergo plating. Animals were killed after 2, 4, and 12 weeks. Larynges were removed and examined to determine the intraluminal area and histologic status of the repair site. RESULTS: The intraluminal area of the animals in the experimental group was 1.6 times that of those in the control group. The trachea was relined with respiratory mucosa by 2 weeks. Little inflammatory reaction was evident. Plate resorption was almost complete at 12 weeks. CONCLUSION: Polydioxanone plating is a feasible and well-tolerated method of extraluminal laryngotracheal fixation. It may be useful in the treatment of grade 2 or 3 subglottic stenosis.

Absorption↗

Comparative study of the holding strength of slipknots using absorbable and nonabsorbable ligature materials.

The holding and tensile characteristics of five extracorporeal slipknots in relation to absorbable and nonabsorbable ligature materials have been evaluated in a standardized in vitro test rig. The knots studied: Tayside, Roeder, Melzer (modified Roeder), Cross square, and Blood knots were tied with the following materials: silk, polyamide, Dacron, polydioxanone (PDS), and lactomer (Polysorb). Following construction and slippage (run down) to a fixed-diameter loop around a cylinder, the knots were locked (tightened) using a standardized force after which they were removed from the test rig and subjected to holding strength (force required to induce reverse slippage) and other tensile characteristics (stress, strain, elasticity) by a tensiometer. Analysis of the data has demonstrated the following: (1) The safest slip knots (resist slippage) are the Tayside, Melzer, and Roeder knots tied with lactomer and Dacron. (2) The holding strengths of the Cross square and Blood knots are weak with all ligature materials tested. (3) Polydioxanone is a safe ligature material for the Melzer and Tayside but not the Roeder knot. (4) Extracorporeal slipknots tied with silk and polyamide are less secure than the equivalent knots tied with Dacron, lactomer, and polydioxanone.

Insect Proteins↗

[Molecular characterization of tissue-engineered articular chondrocyte transplants based on resorbable polymer fleece].

Three-dimensional arrangement and subsequent transplantation of chondrocytic cells in resorbable polymers has been shown to be a promising technique for the treatment of cartilaginous defects. Engineering of artificial cartilage tissue includes dedifferentiation of chondrocytes in monolayer culture, the use of biodegradable matrices and polymer scaffolds, and re-expression of chondrocytic marker genes in three-dimensional culture. The aim of this study was to characterize molecularly the phenotypic changes occurring with autologous cartilage tissue engineering. Human articular chondrocytes were isolated, cultured in medium containing human serum, and expanded up to passage 3. Chondrocytes were embedded in human fibrinogen and in polyglactin-polydioxanon fleeces and cultured three-dimensionally up to 4 weeks. Dedifferentiation of chondrocytes in monolayers and formation of cartilage tissue in vitro or after subcutaneous transplantation into nude mice was assessed by gene expression analysis of typical chondrocytic genes, histology, and immunohistochemistry. The expansion of chondrocytes with human serum resulted in the induction of type I and type III collagens, whereas cartilage-specific type II collagen, cartilage oligomeric matrix protein, cartilage link protein, and aggrecan were repressed and induced again after three-dimensional arrangement of chondrocytes in polyglactin-polydioxanon. Transplantation experiments documented the synthesis of proteoglycan and cartilage-specific type II collagen in vivo. Three-dimensional arrangement of human articular chondrocytes in resorbable polyglactin-polydioxanon fleeces supports chondrogenic differentiation and the formation of a hyaline-like cartilaginous matrix in vitro and in vivo.

Aged↗

Mechanical performance of monofilament synthetic absorbable sutures.

The purpose of this study was to evaluate the mechanical performance of two new synthetic monofilament absorbable sutures. The polydioxanone sutures is prepared by polymerizing and extruding the monomer, paradioxanone, in the presence of a suitable catalyst. The other suture is a modified polyglycolic acid suture, made by reacting trimethylene carbonate and glycolide. The knot configuration (1 = 1 = 1, 1 x 1 x 1, and 2 = 1 = 1) required for knot security was identical for the two synthetic monofilament sutures. The mean knot breaking strengths for the polydioxanone and modified polyglycolic acid sutures did not differ significantly. The surfaces of these sutures exhibited a low coefficient of friction which was slightly increased by hydration. The most distinctive difference between the handling characteristics of these two sutures was their flexural rigidity. The stiffness of the polydioxanone suture was 60 percent greater than that of the modified polyglycolic acid suture.

Polydioxanone↗

The best suture for hypospadias?

In a study designed to determine the best suture for use in hypospadias surgery, polydioxanone (PDS), chromic catgut, and polyglycolic acid (Dexon) were studied under similar conditions in the penile foreskin of 16 baboons. Gross and microscopic observations were made at intervals of six to forty-eight days. The wounds sutured with catgut were all healed by twenty-four days with complete suture resorption and no evidence of scar formation. Both polyglycolic acid and polydioxanone sutures showed delayed resorption, wound abscesses, and granulomas. Catgut remains the best available suture to use in the penile foreskin. Polyglycolic acid and polydioxanone sutures, because of their prolonged resorption and excess reaction, should not be used in hypospadias surgery.

Animals↗

Regenerative periodontal surgery in interproximal intrabony defects with biodegradable barriers.

AIM: The comparison of the effects of guided-tissue regeneration (GTR) using 2 different biodegradable barriers (polylactide acetyltributyl citrate; polydioxanon) in 3- and 2-wall intrabony defects. METHOD: The polydioxanon barrier is an experimental membrane for GTR therapy that consists of an continuous occlusive barrier that has a layer of slings on the side that is meant to face the mucoperiosteal flap. 15 patients provided 15 pairs of similar contralateral periodontal defects: 12 predominantly 2-wall and 18 predominantly 3-wall intrabony defects. Each defect was randomly assigned to treatment with either polylactide acetyltributyl citrate (control [c]) or polydioxanon (test [t]) devices. At baseline and 6 months after surgery, clinical measurements (P1I, GI, PPD, PAL-V) were performed. RESULTS: Barrier exposure was commonly observed in both groups (control/test): 5/4 after 7 days, 9/11 after 14 days and 11/12 after 28 days postsurgically. 4 weeks after surgery, 77% of all barriers were exposed to some extent. However, both treatments revealed a significant GI reduction (p<0.05), PPD reduction [-4.63+/-1.85 mm (t), -4.17+/-1.89 mm (c); p<0.001] and PAL-V gain [3.97+/-1.17 mm (t), 3.40 mm+/-1.40 (c); p<0.001] 6 months after surgery. Regarding GI and PPD reduction as well as PAL-V gain, there were neither statistically significant nor clinically relevant differences between test and control: similar clinical results were found 6 months after surgical treatment using both biodegradable barriers. CONCLUSIONS: Based on the results of the present study, the use of both biodegradable barriers in GTR therapy may be recommended.

Absorbable Implants↗

The effects of ethylene oxide and gas-plasma sterilization on failure strength and failure mode of pre-tied monofilament ligature loops.

OBJECTIVE: To evaluate the effects of ethylene oxide and gas-plasma sterilization on the failure strength and failure mode of pre-tied monofilament ligature loops. STUDY DESIGN: A randomized block design was used by blocking for suture (size 1 polyglyconate, size 2 polydioxanone) and sterilization technique (control, ethylene oxide, gas plasma). SAMPLE POPULATION: Twenty replicates of each suture-sterilization technique combination. METHODS: Ligature loops were pre-tied using a 4S-modified Roeder knot then exposed to 1 of 3 treatments (control, ethylene oxide, or gas-plasma sterilization). Ligature loops were mounted onto a mechanical testing machine to evaluate the effects of sterilization on failure strength and failure mode (disruption, untying). RESULTS: There were no differences between polydioxanone and polyglyconate suture materials in failure strength or mode within sterilization methods. Both sterilization methods significantly increased the likelihood that suture loops would untie compared with controls subjects. Ligature loops that disrupted had a greater breaking strength than those that untied, regardless of sterilization method or suture type. CONCLUSIONS/CLINICAL RELEVANCE: Sterilization with either ethylene oxide or gas plasma of pre-tied, polyglyconate, or polydioxanone ligature loops significantly increases the in vitro likelihood of a modified Roeder knot untying. Further studies need to be conducted to determine the in vivo requirements for ligature loops.

Animals↗

In vitro bursting pressures of jejunal enterotomy closures in llamas.

OBJECTIVE: To evaluate closure strength (in vitro bursting pressure) of jejunal enterotomies in llamas. STUDY DESIGN: In vitro experimental study. SAMPLE POPULATION: Jejunal specimens (n=72) from 6 llamas. METHODS: Differences in bursting pressures and luminal diameters were compared between 2 layer enterotomy closures with an initial full thickness simple continuous pattern oversewn with either a continuous Lembert or Cushing suture pattern using 3 sizes (2-0, 3-0, 4-0) of polyglactin 910 and polydioxanone. RESULTS: Bursting pressures were significantly higher for enterotomies closed with polydioxanone than polyglactin 910, independent of suture size, but there was no difference between Lembert and Cushing oversew patterns. Use of a Lembert pattern reduced intestinal diameter more than a Cushing pattern regardless of suture material or size. CONCLUSIONS: Although polydioxanone resisted higher bursting pressures than polyglactin 910, both suture materials should be considered satisfactory for jejunal enterotomy closure in llamas based on typical intraluminal pressures expected in clinical patients. The optimal oversew pattern may be continuous Cushing to maximize the luminal diameter in small intestinal enterotomy closures. CLINICAL RELEVANCE: In vitro bursting pressures may help to predict which enterotomy sites would leak post-operatively, although further studies are necessary to determine the outcome in clinical patients.

Animals↗

[Comparison of five synthetic absorbable suture materials in intestinal anastomosis: experimental study in rats].

The purpose of this experimental study was to evaluate the efficacy of five synthetic absorbable suture materials in intestinal anastomoses in rats together with their interference with the normal physiopathological cicatrization process. The materials analysed were polyglycolic acid (Dexon), polygluconate (Maxon), polydioxanone (PDS), polygalactic acid (Vycril) and Glycomer 631 (Byosin). 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 Glycomer 631, while polyglycolic acid and polygluconate yielded very good results though giving rise to a greater fibrous component. Polydioxanone and polygalactic acid yielded less satisfactory results. In addition, immunohistochemical techniques were applied to Glycomer 631. The evaluation of the surgical characteristics enabled us to divide the materials studied into two different groups, one in which characteristics such as smoothness and elasticity (Glycomer 631, polygluconate and polydioxanone) prevailed, and the second in which ease of knotting, stitch resistance, memory and lower cost (polyglycolic acid, polygalactic acid and Glycomer 63) prevailed. A general assessment showed better results for polyglycolic acid and Glycomer 631, while the other three materials presented slightly inferior performance, particularly polygalactic acid (inferior stitch resistance).

Anastomosis, Surgical↗

Comparison of two types of synthetic biodegradable barriers for GTR in interproximal infrabony defects: clinical and radiographic 24-month results.

The aim of the present study was to compare the efficacy of guided tissue regeneration (GTR) using two different biodegradable barriers (polylactide acetyltributyl citrate; polydioxanon) in three- and two-walled infrabony defects. The polydioxanon barrier is an experimental GTR membrane that consists of a continuous occlusive barrier with a layer of slings on the side that is meant to face the mucoperiosteal flap. Fifteen patients provided 15 pairs of similar contralateral periodontal defects: 12 predominantly two-walled and 18 predominantly three-walled infrabony defects. Each defect was randomly assigned to treatment with polylactide acetyltributyl citrate (control) or polydioxanon (test) devices. At baseline, 6, 12, 18, and 24 months after surgery, clinical measurements were performed and standardized radiographs obtained (not at 18 months). Both treatments revealed a significant Gingival Index reduction, probing depth reduction, and vertical probing attachment level gain 24 months after surgery. Both treatments showed slight resorption of the crestal alveolar ridge after 24 months, which failed to reach statistical significance. A statistically significant bone gain within the infrabony pockets was measured for both treatment options 24 months postsurgical. Regarding Gingival Index and probing depth reduction as well as vertical probing attachment level and bone gain, there were neither statistically significant nor clinically relevant differences between test and control barriers. The use of both biodegradable barriers in GTR therapy may be recommended.

Absorbable Implants↗

[Experimental study in the urinary tract of a new smooth surface absorbable synthetic monofilament (author's transl)].

The authors used 27 dogs to test the behaviour in the urinary tract of a new synthetic monofilament and absorbable suture material. Polydioxanone (PDS). The experiment was aimed at assessing the strength, ease of use, rate of absorption and lithogenic power of this material, in comparison with chromic catgut. Four loops of each material studied were inserted in the bladder, floating freely in the lumen. Absorption was evaluated by periodic cystoscopies. In the kidneys, one suture of each type was inserted into the excretory cavities by the transparenchymatous route. Development of a possible calculus was sought by urography and repeated plain X-rays of the abdomen. All the animals were killed at 6 months and routine pathological study made of the kidneys and bladder. Certain dogs were infected with proteus and subjected to fluid restriction. The lithogenic power of PDS and chromic catgut appeared to be identical. In contrast with urine, the absorption of chromic catgut by enzyme digestion was more rapid than that of polydioxanone by hydrolysis. By contrast, within the thickness of the tissues, absorption of the latter was more constant and more complete than that of chromic catgut. Polydioxanone caused a less marked tissue inflammatory reaction than the former. Scars were of equal strength. Finally, PDS suture material appears to be remarkably strong and very much easier to use than woven absorbable synthetic materials currently in use.

Animals↗