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Mechanical knot performance of a new generation polydioxanon suture (PDS-2).

To improve the handling characteristics of synthetic resorbable monofilament PDS (polydioxanon), a second-generation (PDS-2) suture has been developed. The mechanical knot performance of this suture was tested in square knots and sliding knots and compared with other monofilament suture materials. Knot performance was defined by the loop holding capacity (LHC) and expressed in Newton's (N). Maxon (polyglycolid-three-methylene carbonate) had significantly better knot performance than the other sutures. Knot performance of Prolene (polypropylene) was significantly poorer than that of the other sutures. Ordinary PDS (polydioxanon) and PDS-2 (polydioxanon) showed intermediate results. Knot performance of PDS-2 was similar to (square knots) or poorer than (sliding knots) that of ordinary PDS. It was concluded that knot performance of ordinary PDS is not improved by the introduction of PDS-2. It is emphasized that surgeons should be aware of the mechanical properties of newly developed suture materials. Underlying factors and clinical implications of the mechanical performance of PDS-2 are discussed.

Humans

[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

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

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

[Maxon and PDS--evaluation and physical and biologic properties of monofilament absorbable suture materials].

The physical parameters of monofilament absorbable sutures (Maxon and PDS) were studied. Compared to PDS Maxon proved somewhat more unwieldy, however, it required less complicated knot combinations for a secure placement than PDS did. In vivo experiments on rats showed a slight tissue reaction and a dissolution time of 120-180 days for Maxon and 180-240 days for PDS. With Maxon, tensile strength was measurable for 42-49 days, while the period for PDS amounted to 65-80 days. New indications for these materials are discussed, two parameters, easy knot formation and atraumatic passage through the tissue, especially favor the use of Maxon for one-row all-layer sutures in the gastrointestinal tract.

Animals

[Stabilization of the injured shoulder joint with PDS cord].

A successful treatment of the acromioclavicular separation is the repair of the acromioclavicular and coracoclavicular (CC-)ligaments and a stable reduction of the acromioclavicular (AC-)joint. To avoid dangerous breakage and migration of the K-wire an abduction humeral splint is necessary immobilizing the injured shoulder for 5-6 weeks. In the years 1987-1989 40 patients suffering AC-separation were treated (34 Tossy III separations, 4 Tossy II separations, 2 Tossy I separations). In these cases a stable reduction was achieved by a transarticular K-wire fixation and a combination of AC- and CC-fixation by loops. In 1987 wire loop was used. In 1988 a combination of wire and Polydioxanon (PDS) loops was used. The PDS-loop, a slowly resorbable suture material, fixed the CC-ligament. In 1989 the AC-joint was stabilized by a PDS-loop as well. The examination of 31 patients 6-24 months after the operation showed good clinical results no matter whether PDS-loops or wire loops were used. The advantage of the transarticular K-wire fixation in combination with PDS-loops was the easy removal, which could be done in mostly of the cases as an outpatient procedure. An operation of the AC-Tossy III separation on patients beyond their 4. decade should be well considered. A long time of treatment, remaining pain and a limitation of shoulder movement must be expected.

Acromioclavicular Joint

Coenzyme dependent suppression of 2,2-PDS induced contractures in Spirostomum.

Spirostomum ambiguum was stimulated to contract by addition of the thiol inhibitor, 2,2-dithiobispyridine (PDS), which depletes intracellular reducing equivalents which are generated by coenzyme dependents reactions. PDS induced contractures were not suppressed after 2--4 h of pre-incubation in a medium enriched with ascorbic acid, thiamine, or riboflavin, singly. Two h of incubation with nicotinamide did not suppress contractures; however, 50% suppression occurred after 3 h incubation. Incubation of the cells in a medium enriched with all four coenzymes for up to 4 h, resulted in the suppression of PDS induced contractures to a level as low as 30% of control values. Suppression of contractures by the mixed coenzymes was concentration dependent. Cells that were stimulated with PDS and contracting, exhibited a 50% suppression of contractures within 3 min after transfer to a complementary medium enriched with mixed coenzymes. These results suggest that coenzymes interact synergistically with cellular metabolic processes to inhibit pharmacodynamic responses to PDS.

2,2'-Dipyridyl

Microsurgical use of polydioxanone (PDS) suture: an experimental report.

Although many technological advances have been made in surgical materials, nylon is still the main suture material use for microvascular surgery. This study sought to evaluate polydioxanone (PDS) sutures for use in microvascular anastomoses. Twenty-eight male Sprague-Dawley rats were used in this experiment. Spatula-type needles with 9-0 PDS suture were used to anastomose the right femoral arteries, with 9-0 nylon used on the left side. The arteries were observed for 1, 2, 3, 4, 8, 12, and 16 weeks after surgery to determine arterial patency and to evaluate vascular pathology. Results were comparable between PDS and nylon. We suggest that if the suture material is redesigned to allow smooth passage through the tissue, and if the needle used in conjunction with the suture is improved, PDS may offer an excellent material for microvascular anastomosis.

Anastomosis, Surgical

Subclavian flap angioplasty with absorbable suture polydioxanone (PDS). An experimental study in growing piglets.

The fate of the subclavian flap in aortoplasty was studied and a new synthetic monofilament, absorbable vascular suture (polydioxanone, PDS) was evaluated. In 11 piglets submitted to the aortic repair, the diameter of the aortic arch and descending aorta and the length and width of the subclavian flap were measured. The aortoplasty was performed with a continuous running suture of 6/0 PDS. All the animals survived and grew normally. They were sacrificed 6-26 weeks postoperatively, when the mentioned variables were reestimated. No aortic narrowing was found and no suture material was detectable in the lumen. The subclavian flap had grown uniformly in length and width. Histologic examination showed evening of the inner surface by intimal proliferation and healing of the anastomoses. There was no sign of flap destruction and tissue reaction to PDS suture was minimal, indicating normal growth and viability in all parts of the flap. The suture material was absorbed 26 weeks postoperatively. Continuous suture with absorbable PDS seems to be a good alternative for repair of aortic coarctation in early infancy.

Animals

[Ligament repair with PDS (polydioxanone) in chronic insufficiency of the fibular ligament of the upper ankle joint: experimental and clinical experiences].

From September 1988 till February 1989, 14 patients with chronic ligamentous rupture of the ankle had been operated on using PDS-plasty. Of 12 patients checked in follow-up examination (mean postoperative period 45 weeks), only two showed good or very good results. Most patients had the same signs of chronic instability as preoperatively. Two patients had been reoperated on. Intraoperatively we did not find a biological substitute along the PDS guide line. In an experiment on the rat we examined histological changes and tensile strength at appointed times. Histological data showed no biological substitute of PDS. We also found residues of PDS even after 300 days. After a short time loss of tensile strength occurred. In view of an aseptical necrosis that occurred in our experiments, we must point out the risk of foreign body granulomas.

Adolescent

Growth of tracheal anastomoses in lambs. Comparison of PDS and Vicryl suture material and interrupted and continuous techniques.

Tracheal anastomoses were performed in 19 lambs (mean age 4 weeks, mean weight 9.8 kg) to compare polydioxanone (PDS) and polyglactin 910 (Vicryl) suture material (Ethicon, Inc., Somerville, N.J.) and simple continuous and simple interrupted suture technique. Each animal had two anastomoses with full-thickness bites for both suture techniques. Animals were killed at 4 months (n = 6) or 8 months (n = 5). Eight animals died before they were scheduled to be put to death (mean 6 weeks postoperatively). Transverse sections of the trachea were taken at the level of the anastomoses and three tracheal rings above and below each anastomosis. The cross-sectional area of the tracheal lumen of these transverse sections was measured with a computerized digitizing tablet. A percent luminal area for each anastomosis was calculated relative to the mean tracheal area three rings above and three rings below the anastomosis. There was little difference between interrupted and continuous technique with either suture material (p = 0.94). In 10 animals that each served as its own control for suture material, PDS anastomotic area was 55.0% +/- 4.1% of mean tracheal luminal area compared with 45.4% +/- 7.1% for Vicryl anastomoses (p = 0.06). Histologic analysis revealed a more intense inflammatory reaction surrounding multifilament Vicryl sutures with more rapid resorption and greater subsequent fibrosis relative to the reaction seen with PDS sutures. A small clinical experience with seven infants has confirmed short-term satisfactory clinical performance of continuous PDS suture for tracheal anastomosis.

Anastomosis, Surgical

[Augmentation of the coraco-clavicular ligament suture. Comparison between wire cerclage, vicryl tape and PDS cord].

A total of 71 patients (average age 32 years) with acute grade III acromio-clavicular dislocation were all treated with the same surgical procedure: open reduction, transfixation of the acromio-clavicular joint with a Kirschner wire and suture of the coraco-clavicular ligaments with augmentation. The augmentation was done with a 1.2-mm wire cerclage in the first group (22 patients), a 3-mm wide Vicryl tape in the second group (30 patients) and a 1.5-mm PDS cord in the third group (19 patients). At follow-up (average time 4.4 years) the patients were questioned as well as being examined radiologically and clinically. Only two patients were not satisfied with the outcome of surgery. On clinical evaluation after wire cerclage augmentation of the suture, the distal end of the clavicle was found to be dislocated in 23% of cases. The incidence was 20% after Vicryl taping and 58% after PDS cord augmentation. At X-ray examination with 8 kg suspended from the wrist acromio-clavicular dislocation was found in 45% after wire cerclage, 23% after Vicryl taping and 58% after PDS cord augmentation of the suture. The results show that dislocation is more likely to persist after augmentation of the suture of the coraco-clavicular ligaments with wire cerclage or PDS cord than when the suture is augmented with a Vicryl tape. We conclude that a resorbable material is suitable for augmenting the suture of the coraco-clavicular ligaments, but that a filiform augmentation is less appropriate than a band.

Acromioclavicular Joint

Comparison of Maxon suture with Vicryl, chromic catgut, and PDS sutures in fascial closure in rats.

Two hundred ten rats were randomized into one of five study groups to compare standard absorbable sutures with a new synthetic absorbable suture. We evaluated Maxon (polyglyconate), Vicryl (polyglactin), chromic catgut (catgut), and PDS (polydioxanone) with respect to tissue inflammatory reaction, knot security, suture tensile strength, and suture absorption. The results indicate that Maxon and PDS elicited a lower degree of chronic inflammation when compared with Vicryl and chromic catgut. The tensile strengths of Maxon and Vicryl significantly exceeded those of PDS and chromic catgut during the critical period of wound healing. Maxon and PDS retained a larger percentage of tensile strength during the long postoperative period, whereas Vicryl and chromic catgut were mostly absorbed. Maxon is an excellent addition to the armamentarium of the gynecologic surgeon.

Absorption

[Ligament replacement with polydioxanone (PDS)].

Experimentations on animals have been performed in order to verify the applicability of the slowly resorbable suturing material Polydioxanon (PDS) in the transposition of ligaments in general and the transposition of cruciate ligaments in particular. After six weeks, the absorption of a twisted cord of 2 mm diameter still has a traction tolerance of 58%. The experimentations made on rabbits and sheep suggest that PDS can be used to fasten ligament sutures and to reinforce ligament grafts. Under extremely favorable soft tissue conditions, the substance can even be used as ligament substitute. Good clinical results can be achieved in the problematic plastic surgery of the anterior cruciate ligament if the reinforcement of the autologous transplant is performed with PDS in the sense of an augmentation graft.

Animals

[Mechanical properties of PDS-augmented patellar tendon transplants in reconstruction of the anterior cruciate ligament].

In 25 sheep the anterior cruciate ligament (ACL) was reconstructed after resection. Twelve modified "Jones procedures" were performed (transplantation of the central third of the patellar tendon with an initial load of 50 N) and 13 polydioxanone (PDS) augmentations. In 15 cases the ACL was resected from the right knee. Twenty-one sheep survived for 1 year and were then evaluated. Loss of the ACL leads to instable joints in this experiment. Within the first 6 months anterior translation occurs; after 1 year subluxations can be seen on the X-ray films. Macroscopical signs of extensive arthrosis were seen in the femorotibial and femoropatellar joints; the menisci were totally destroyed. Macroscopically strong ligaments were seen 1 year after PDS-augmented reconstruction as well as after transplantation of the patellar tendon with an initial load of 50 N. There was no difference between the two groups. The mechanical strength reached 54% of the maximum load of a control group in the Jones reconstructions and 61% after additional augmentation with a 2-mm biodegradable PDS cord. There was no statistically significant difference. Both methods are suitable for reconstruction of the ACL; the patellar tendon replaces the ACL very well.

Animals

[Follow-up results of ligament replacement by PDS in chronic lateral ligament instability of the upper ankle joint].

From September 1988 till February 1989 we have operated on 14 PDS-ligament replacements of the ankle in patients with chronic lateral instability. Only one patient had an excellent clinical result with a stable ankle. Ten of twelve patients had poor results at follow-up. 2 patients had been reoperated on. We did not find biological substitute along the PDS guide line. This suggested the opinion, the PDS-ligament replacement of the ankle can't realize the expectations.

Adolescent

[Synthetic absorbable PDS explant for the treatment of retinal detachment].

The following article discusses the experimental and clinical reasons for using absorbable synthetic explants in retinal surgery. We have carried out experimental studies with absorbable synthetic explants bandmade from absorbable sewing threads: PG910, PGA and PDS; proving that these explants are well tolerated by the organism. Their reabsorption time is from 45 days using PG910, to 8 months using PDS; these periods are sufficient for proper anatomical healing of the retina to take place. We present 13 cases of extraction of Teflon explants after retinal detachment surgery; in none of these cases did re-detachment of the retina occur. Consequently, this induced us to introduce absorbable synthetic explants into retinal detachment surgery, using absorbable threads, having previously carried out an experimental study on rabbits. We present 10 cases of retinal detachment operated on with PDS from 95 cases operated on using absorbable synthetic explants; 100% anatomical healing of the retina was achieved. We consider this type of explant to be the ideal material for retinal detachment healing, due to the fact that its period reabsorption, being longer than those of the other explants, allows a longer indentation period.

Absorption