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The effect of a penetrating biodegradable implant on the growth plate. An experimental study on growing rabbits with special reference to polydioxanone.

This study examined the fate of a biodegradable polydioxanone (PDS) implant in growing bone in rabbits. In 20 immature rabbits, a PDS rod 2.0 mm in diameter and 25 mm in length was driven into a drill hole of equal bore in the intercondylar portion of the right femur across the central portion of the growth plate. In another 25 immature rabbits, a PDS rod 3.2 mm in diameter and 25 mm in length was driven into a corresponding drill hole using the same technique. The follow-up intervals were three, six, 12, 24, and 36 weeks. The distal femoral growth plates of both femora were analyzed by roentgenographic, microroentgenographic, oxytetracycline-fluorescence, histologic, and histomorphometric studies. Histomorphometric studies showed clear changes at the site of injury and appeared to be an excellent means of providing an exact numerical description of the different cellular areas of the growth plate in experimental studies. A transphyseal PDS implant 2.0 mm in diameter did not cause any permanent growth disturbance of the femur in a growing rabbit. An implant 3.2 mm in diameter caused a growth disturbance similar to a drill hole of equal bore.

Animals↗

[Single-layer closure of a subcostal incision using a monofilament absorbable suture material--comparison of polydioxanone (PDS) and polyglyconate (Maxon)].

In 114 and 108 patients who were operated upon the biliary tract with a subcostal incision and closed in one layer with Polydioyanone (PDS) and Polyglyconate (Maxon), the authors analysed the frequency of the complications in the healing of the operative wound. A superficial infection in the wound appeared in 1% and 0.9% of the patients in the PDS and Maxon group, while a deep infection of the wound appeared in 0.8% and 0% (P less than 0.05). In "contaminated" wound patients, the frequency of the deep infection of the wound was not significantly larger than the "clean" operations (P less than 0.05). The total frequency of the deep infection of the wound in 222 patients was 0.4%. There was no dehiscence of the wound abscesses or ligature fistulas. 4 months following surgery 92% and 90% of the patients from the PDS and Maxon group were checked; an incisional hernia was preceded by an infection of the surgical wound in both the PDS (0.9) and Maxon (1%) group. Risk-factors (older patients, sex, overweight and icterus) did not have any effect on the healing of the wounds. In 66% of the patients of the PDS and 62% of the Maxon group, the gallbladder bed was not drained. The difference in the development of complications in the healing of the surgical wound between the two drained groups was not statistically significant (P less than 0.5). With a one layer closure of the subcostal incision with PDS or Maxon, complications in the healing of the wound were significantly reduced. The purpose of our study was: a clinical evaluation and comparison of the two monofilament absorptive suture materials-Polydioxanone (PDS) and Polyglyconate (Maxon) during a one layer closure of surgical interventions on the biliary tract, and evaluation of certain risk-factors in the healing of the surgical wounds.

Absorption↗

Polydioxanone in coronary vascular surgery.

We have used polydioxanone (PDS) in 50 patients who underwent coronary artery bypass grafting. The anastomoses consisted of suturing an autologous vein graft to the coronary artery (122 operations), a vein graft to the aorta (63 operations) and the internal mammary artery to the coronary artery (33 operations). The recipient coronary artery was subjected to endarterectomy in 28 instances. The anastomoses proved to be reliable in the early postsurgical period; no bleeding was attributed to the PDS suture. Clinical follow-up for a maximum of two-and-half years, completed using control coronary angiograms in selected cases, demonstrated good results. The practical properties of PDS were evaluated to be at least as good as those of polypropylene. Experiments have clearly shown that small artery anastomoses heal more favourably after the use of absorbable sutures than after the use of nonabsorbable sutures. Because of this finding and on the basis of our clinical experience, we believe the application of PDS in coronary surgery should be recommended as an alternative treatment.

Adult↗

Subcuticular skin closure following minor breast biopsy: Prolene is superior to polydioxanone (PDS)

The aim of this study was to determine whether a subcuticular absorbable suture (polydioxanone acid, PDS, Ethicon, UK) was superior to a subcuticular non-absorbable suture (Prolene, Ethicon, UK) for day-case breast biopsy performed under local anaesthesia. After breast biopsy, the type of subcuticular suture to be used was randomized in 100 patients. In all other respects the surgery and written postoperative instructions were similar for the group. Patients were reviewed over two visits by one independent observer who was unaware of the suture utilized (median 10 days and 52 days after surgery). Three patients had incomplete documentation and four patients failed to attend for either visit: thus 47 and 46 patients in the Prolene and PDS groups, respectively, were assessed. There was no difference between the Prolene and PDS groups, respectively, in the median interval to either the first shower or removal of the original plaster. There were three wound infections (one with Prolene, two with PDS). At the first visit three patients in the Prolene group had their incision uncovered, compared to 20 patients in the PDS group. In the PDS group a buried knot eroded through the incision in eight patients (17%). In this study the expected advantages of an absorbable suture were not confirmed.

Adult↗

Polydioxanone in anastomosis of rabbit tubes. A morphological study of the epithelium.

Eight NZW rabbits were submitted to end-to-end tubal anastomosis using polydioxanone (PDS), (Ethicon). The animals were sacrificed at two-week intervals between the second and sixteenth week after operating. The tubes were removed and analysed with the scanning electron microscope for the purpose of studying the morphology of the epithelium. Ciliogenesis was completed between the second and fourth weeks. After this period the epithelial conditions observed were completely normal, except for an abundant mucous secretion which, however, was totally normal after sixteen weeks.

Animals↗

The use of absorbable monofilament polydioxanone suture in pediatric cardiovascular operations.

Growth of suture lines and anastomoses is required for long-term success after the repair of congenital cardiovascular anomalies. Polydioxanone, an absorbable monofilament suture material, has been used in a variety of operations since April, 1983. Twenty-two of the 46 procedures were coarctation repairs. Complete repairs for anomalous pulmonary veins and transposition of the great arteries, as well as Fontan procedures and systemic-pulmonary shunts, have been performed. Angiographic, gross, and microscopic examination showed good healing. There was no anastomotic disruption or aneurysm formation. The results with this absorbable vascular suture have been uniformly encouraging in a follow-up of up to 30 months.

Aortic Coarctation↗

Polydioxanone suture in the gastrointestinal tract.

A randomized prospective trial was undertaken of polydioxanone suture (PDS) versus conventional suture material in 98 patients undergoing anastomoses in the gastrointestinal tract. Nine patients died within 6 months of surgery, one of these being related to an anastomotic leak. All other patients were followed up for between one and three and a half years. In 57 colonic anastomoses, 30 were randomized to a single layer of 2/0 (BPC) interrupted PDS and 27 to a single of 2/0 (BPC) interrupted silk. Follow up sigmoidoscopy and barium enemas were used to confirm the clinical suspicion of 6 benign anastomotic strictures, 5 of which occurred in the PDS group. At this stage, the colonic arm of the trial was discontinued because the 19% stricture rate with PDS was deemed unacceptable. In a second limb of the study, patients were randomized to two layers of 2/0 (BPC) continuous PDS or 2/0 (BPC) continuous chromic catgut. There were no significant differences in 32 gastric or small bowel anastomoses and in particular, no anastomotic strictures were apparent. The reasons for the high rate of stricture formation when using PDS for large bowel anastomoses are unclear. However, it would seem to be a suitable alternative to chromic catgut when confined to the stomach and small intestine.

Adult↗

A randomised comparison of polydioxanone (PDS) and polypropylene (Prolene) for abdominal wound closure.

Two hundred and eighty four patients undergoing laparotomy by vertical incision were randomly allocated to closure with interrupted mass sutures of No. 1 polydioxanone (PDS) or No. 1 polypropylene (Prolene). Dehiscence occurred in 0.7% of the PDS group but in 6.4% of the Prolene group (P = 0.018). Wound infection occurred in 8.6% of the PDS group and 15.4% of the Prolene group (P = 0.1). One hundred and ninety patients attended for review at a minimum of one year. Incisional herniation, usually asymptomatic, was present in 11% of each group. Knots were palpable in 2% of the PDS patients but in 12% of the Prolene: wound pain occurred in 12% of the PDS group but in 23% of the Prolene group (P = 0.06). These results suggest that PDS may be useful for abdominal closure.

Abdomen↗

The use of a new suture material (Polydioxanone) in the biliary tract.

The use of a new synthetic absorbable suture material, polydioxanone, has been assessed over a period in excess of three years in 63 patients undergoing surgical procedures on the biliary tract. The material, which was used exclusively for all ligatures and sutures, has greater pliability and strength than other absorbable materials and was found to be highly satisfactory. No suture-related complications were identified and the handling properties of the material were excellent. This material can be recommended for use in the biliary tract where it is desirable to use a reliable absorbable suture which evokes minimal tissue reaction.

Adult↗

[Absorbable polydioxanone monofilament in the surgery of the anterior segment of the eye].

PDS (Polydioxanone suture), a new synthetic absorbable suture, was used in experimental and clinical trials. The experiment was performed on 14 rabbits anesthetized with intravenous sodium pentobarbital. Five months were needed for complete absorption of a piece of PDS left in a tunnelled corneal stroma. As late as the end of the second month no histological absorption was detected. This was twice as long as that persistence of polyglactin sutures studied under the same experimental conditions. In another series of 12 animals, the PDS suture was placed in the central cornea and tied with a buried knot. The PDS suture broke four to six weeks postoperatively in the superficial part of the cornea. The histologic tissue reaction in both these studies was minimal, resembling that obtained with black 10/0 monofilament nylon. In the clinical study, PDS sutures were used (size 0.2 metric and 0.3 metric) in 38 cases of cataract extraction. The material was easy to handle, especially when dyed violet. No side-effects attributable to the suture material were observed. PDS retained its tensible strength longer than other absorbable sutures, but can be used only for closing limbal incisions with conjunctival flaps in order to prevent tear hydrolysis of the suture.

Absorption↗

Macroscopic and histologic tissue reaction to polydioxanone, a new, synthetic, monofilament microsuture.

A major contributing factor to failure in reconstructive tubal surgery is adhesion formation. It can be due to the presence of a foreign body primarily represented by suture material. A new, synthetic, absorbable suture material, Polydioxanone (PDS), was compared to polyglactin -910 (Vicryl). Microsurgical anastomosis of the bicornuate rat uterus served as a model. The right horn was anastomosed with 6-0 or 8-0 PDS and the left horn with Vicryl of the same diameter. At 3, 7, 14, 30 and 60 days after the procedure three to four animals were killed and the histologic reaction estimated and compared between the two horns. At 60 days the remaining animals were killed, and adhesion formation around the anastomosis site was recorded. PDS was found to be histologically more inert than Vicryl and was associated with a less intense acute and chronic inflammatory response than Vicryl. Similarly, macroscopic examination showed that the adhesion formation was quantitatively reduced in the PDS-treated horns, and most of those adhesions were avascular. The high inertness and absorbability suggest a practical application of PDS in infertility surgery.

Animals↗

Polydioxanone in vascular surgery. First experience with an absorbable suture in femoro-popliteal bypass.

The use of synthetic absorbable monofilament suture material (polydioxanone, PDS), is described for operative vascular surgery. Six anastomoses in three femoro-popliteal (tibial) vein bypass operations were performed. Angiographical control was carried out, when absorption was in progress (after a period of five months) or totally completed (within six months), and showed no dilatation or aneurysm formation at the suture line. One anastomosis was excised five months after the first intervention. Histological examination showed fragmented suture material and slight tissue reaction. Suture material characteristics in respect of tensile strength, pliability, knotting properties and visibility were judged critically.

Aged↗

Polydioxanone absorbable sutures in vascular anastomoses: experimental and preliminary clinical studies.

To assess the safety and efficacy of polydioxanone suture (PDS) for vascular anastomoses, bilateral carotid end-to-end anastomoses using PDSs on the left and Dacron sutures on the right in 18 dogs were performed. The anastomoses were assessed at 4, 6 and 8 weeks after surgery. A breaking-strength test (300 mmHg) did not show a significant difference between PDS and Dacron anastomoses, but partial absorption was grossly evident in the PDS group. Some 35 venous and 21 arterial reconstructive procedures were also carried out using PDS in 53 patients. At follow-up of 3-5 (mean 3.5) years, none of the patients had experienced any suture-related complications. The results indicate that PDS maintains an adequate tensile strength in anastomoses until suture-line healing occurs, suggesting that this material may be safely used in venous or small arterial anastomoses. In addition, because it is absorbable, resulting in decreased foreign-body reactions, PDS may have the potential to improve the long-term patency of venous or small arterial reconstructions.

Adolescent↗

Suitability of biodegradable polydioxanone materials for the internal fixation of fractures.

A distal femoral osteotomy in 46 rabbits was fixed either with biodegradable polydioxanone (PDS) thread and pins (group A, 31 animals) or with metallic Kirschner wire and pins (group B, 15 animals). Postoperatively, the distal part of each femur was removed and evaluated, and bone sections were evaluated by histology and histomorphometry. Macroscopic studies showed complete PDS absorption in all cases 24 weeks postoperatively. The histologic studies revealed new bone surrounding the area of the implant 3 weeks postoperatively, and at 24 weeks postoperatively, there was thinning or disappearance of the new bone around the implant. On the basis of the present study, PDS thread and pins show promise for the fixation of osteotomies or fractures of cancellous metaphyses of small long bones, such as metacarpals and phalanges.

Animals↗

Skin closure using nylon and polydioxanone: a comparison of results.

Nylon vertical mattress sutures and interrupted subcuticular polydioxanone (PDS) sutures have been used for skin closure. The complications and cosmetic results of each have been noted in a prospective trial of 93 hip wounds. When nylon sutures are used there is an increased incidence of erythema and the final scar is less cosmetically attractive. Interrupted PDS sutures take longer to insert but have few complications and are recommended in both the young and elderly patients.

Adult↗

[Effects of polydioxanone and silk on normal cicatrisation of surgically injured myocardial tissue. An experimental model].

The wound healing is the principal process of tissue repair. In the heart this phenomenon is done under special circumstances, because of the constant movement of this organ. An experimental study was done in 15 dogs. By left anterolateral thoracotomy the free left ventricular wall was incised. This incision was done 1 cm long and 3 mm deep and afterwards it was repaired with silk (Group I) and with polydioxanone (Group II). The wound was allowed to heal during 5 weeks, then the scar area was analyzed by light microscope with Masson and HE technics. The results showed the presence of lymphocytes in the scar tissue of group II (p = 0.04).

Animals↗

[Atrial septal defect with tricuspid valve regurgitation and heart failure in early childhood: report of a case with successful surgical management consisting of special patch closure technique and use of polydioxanone suture for the tricuspid annuloplasty].

A management of surgery for infant having a small left ventricular cavity associated with atrial septal defect and tricuspid valve regurgitation was presented. A right upper part of the defect was remained in open during a patch closure of ASD and this portion was temporarily sutured by prolene stayed extracardialy through Waterston's groove. During 20 minutes after weaning from the cardiopulmonary bypass, left heart failure did not appear and then it was completely closed. DeVega's method was employed for the tricuspid valve regurgitation using a absorbale Polydioxanone suture, because of a growth of the sutured annulus. Postoperative course was uneventful and trivial tricuspid valve regurgitation was recognized in angiocardiographic studies performed in 2 weeks and 6 months after operation.

Child, Preschool↗