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PubMed2000

Comparative study on biocompatibility and absorption times of three absorbable monofilament suture materials (Polydioxanone, Poliglecaprone 25, Glycomer 631).

Monofilament synthetic absorbable suture materials offer excellent glide characteristics and cause minimal tissue trauma as a result of their smooth monofilament structure and gradual bio-absorption. An investigation was conducted on 72 rats to compare three types of monofilament absorbable suture material (Polydioxanone, Poliglecaprone 25, Glycomer 631), with respect to their clinical characteristics, tissue inflammatory reaction and suture absorption times. The results identified different qualities for each suture: Poliglecaprone 25 and Glycomer 631 suture materials were found to be less reactive than Polydioxanone in rat skin. However, because of their extremely low tissue reaction values, all three materials were deemed particularly suitable for use as intracuticular sutures. Absorption times in rat skin were less than 3 months for Poliglecaprone 25, between 3 and 6 months for Glycomer 631 and 6 months for Polydioxanone. The differences in suture characteristics which were detected in our study can help in the surgical selection of the most appropriate suture material.

Animals↗
PubMed2002

Orbital floor reconstruction with an alloplastic resorbable polydioxanone sheet.

The orbital floor is frequently reconstructed after blow-out fractures or midface fractures to avoid a relapse of the repositioned orbital tissue and to prevent enophthalmos. A total of 31 patients underwent reconstruction of internal orbital wall fractures with a resorbable 0.25 mm or 0.5 mm-thick polydioxanone implant (PDS). Skeletal and functional outcome was evaluated retrospectively with regard to fracture size. Fracture size was graded as small, moderate or large by CT scans and operating records. Two of the 25 patients with small or moderate defects showed an enophthalmos of 2-3 mm. Five of the six patients with large defects or two orbital wall fractures had enophthalmos. The scar that formed after implant resorption was to weak to provide adequate support of the globe or to compensate the enlarged orbital volume. Endoscopic follow-up examination of 12 patients showed yielding of the scar in the orbital floor already in moderate defects. Eight patients had diplopia in extreme gaze and two had significant diplopia. Blow-out and midfacial fractures with small to moderate defects in the orbital floor (up to a size of 2.5 cm2) can be reconstructed by polydioxanone sheet to avoid enophthalmos. Polydioxanone implants should only be used in cases without massive orbital fat herniation. The scar formed after implant resorption may influence functional outcome.

Absorbable Implants↗
PubMed2002

Comparison of the mechanical properties of polyglycolide-trimethylene carbonate (Maxon) and polydioxanone sutures (PDS2) used for flexor tendon repair and active mobilization.

Thirty-six canine flexor digitorum profundus tendons were repaired using 5-0 polyglycolide-trimethylene carbonate monofilament (Maxon) or polydioxanone monofilament (PDS2). All the tendons healed without rupture or formation of gaps of more than 2 mm. Mechanically, all tendon repairs had sufficient tensile strength to enable active mobilization. Polyglycolide-trimethylene carbonate (Maxon) repairs were initially superior in gap and ultimate strength to polydioxanone (PDS2) repairs. However, the gap and ultimate tensile strength of polyglycolide-trimethylene carbonate (Maxon) repairs had decreased significantly at day 14, whereas polydioxanone (PDS2) repairs maintained their strength throughout the 28-day observation period.

Animals↗
PubMed1991

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↗
PubMed1991

A prospective randomized comparison of continuous polydioxanone and interrupted Neurilon for neurosurgical wound closure.

A prospective, randomized study of continuous Polydioxanone with subcuticular vicryl closure is compared to interrupted Neurilon in a general neurosurgical practice. Ninety-nine patients were studied with 49 closed with Polydioxanone and 50 by Neurilon. The two groups were comparable with respect to risk factors and general composition. There was no significant difference in the rate of infection, wound dehiscence, CSF leak or suture protrusion, but Neurilon had a significantly higher incidence of palpable knots. Wound closure time was compared with no overall difference being found. We conclude that continuous Polydioxanone closure with subcuticular vicryl is an acceptable form of closure for neurosurgical wounds.

Adult↗
PubMed1986

Use of polydioxanone absorbable monofilament sutures in orthopedic surgery.

The safety and efficacy of polydioxanone absorbable monofilament sutures was documented in 57 orthopedic surgery patients (32, dyed sutures; 25, undyed sutures), 55 of whom were followed for at least 42 days postoperatively. The other two patients were lost to follow up prior to 42 days. The final clinical outcome was excellent in all completed study subjects. No suture-related adverse effects were reported. Both dyed and undyed sutures were consistently better than surgical gut with respect to pliability, strength, ease of passage, ease of tying, fraying, knot security, and overall handling. Intraoperative visibility of dyed polydioxanone sutures was consistently superior to that of surgical gut. The visibility of undyed sutures was rated better than surgical gut in 16 cases, equal in 8, and worse in 1. Both the overall handling of the polydioxanone monofilament sutures and performance as it affected wound healing were significantly superior to those of surgical gut.

Adolescent↗
PubMed1988

Polydioxanone and polypropylene suture material in free internal mammary artery graft anastomoses.

An experimental study with six beagle dogs was conducted to evaluate a new monofilamentous absorbable suturing material--polydioxanone. Free internal mammary artery grafts, 3 cm long, were harvested via a median sternotomy and were implanted as arterial bypasses in femoral arteries (12 end-to-end anastomoses) and as arteriovenous shunts in the carotid artery-contralateral jugular vein position (12 end-to-side anastomoses). Twenty-four anastomoses were made with monofilamentous nonabsorbable suturing material, polypropylene (12 arterial, 12 shunts), to serve as control grafts. At 6 months the grafts and anastomoses were explanted and studied with light and scanning electron microscopes. Macroscopically, the polydioxanone sutures had disappeared. The major histologic finding was the foreign body reaction around the polypropylene sutures. In the electron microscopic study the endothelial line covered the anastomotic site and in the polypropylene anastomoses the suture material was bulging up from the anastomoses. No aneurysms or dilatations were seen. According to this study, polydioxanone is a suitable suturing material for small luminal arterial anastomoses and is superior to polypropylene suturing material because it causes no tissue or other late changes on the flow surfaces.

Animals↗
PubMed1985

A clinical evaluation of absorbable polydioxanone ligating clips in abdominal and pelvic operations.

An absorbable vascular ligating clip made of polydioxanone polymer was evaluated in 44 patients who underwent abdominal and pelvic operations. These clips were used in place of conventional metallic clips primarily in performing pelvic and para-aortic lymphadenectomy. The polydioxanone clips were found to be superior to the metallic clips in ease of clip loading to the applier, security of clips in the transfer to the surgeon and security of the clip in the applier when positioning to ligate vessels. The use of polydioxanone clips, which absorb within 210 days, may also lead to improved CAT or NMR imaging by precluding energy scatter which is known to occur with some metallic clips. Clip applier function, security on tissues ligated and clip visibility were equivalent to previous experience using metallic clips. Selection of proper clip size is important so that excessive amounts of tissue are not contained within the clip jaws which might prevent clip closure. No postoperative complications were noted in the use of these clips.

Absorption↗
PubMed1983

[Polydioxanon (PDS)--a new monofilar synthetic, absorbable suture material. Tensile strength studies in a controlled clinical trial on the large intestine of humans and physical parameters in in vitro tests].

We investigated the properties of tensile strength for the following suture materials: Polyglycolic acid (2. and 3.generation), Polyglactin 910 (3.generation) and Polydioxanon. They were situated within human large bowels for 10 to 12 days and investigated in a controlled experimental procedure. The decrease of the tensile strength in the human large bowel is significantly slower for polydioxanon suture (PDS) than for PGA (2. and 3.generation) and Polyglactin 910 (3.generation) suture. As PDS-suture are primarily less tractable than the others, there is no significant difference of tractability between all sutures after 11 days of implantation within the human colon. For PGA (3.generation) and Polyglactin 910 we found a strong loss of tractability after 10 to 12 days. In a second experimental series tensile strength, knot breaking security and knot holding capacity were tested in a tensiometer for absorbable suture materials with 3 and 6 parallel knots. The tensile strength was higher than the knot security for all sutures. Coated suture material (PGA and Polyglactin 910, both 3.generation) as well as the new monofile polydioxanon must be knotted manyfold for a secure knot position.

Adult↗
PubMed1993

One layer continuous anastomosis of the alimentary tract with absorbable polydioxanone suture.

A prospective study using absorbable Polydioxanone (PDS) suture material in a one layer continuous technique for gastrointestinal anastomosis was conducted. There were 40 anastomoses constructed in 39 children and 61 anastomoses in 49 adults which were classified as "non-complicated anastomoses" without any clinical evidence of leakage or any other complications attributable to the anastomotic technique or to the suture materials. There were other 20 anastomoses created in 20 patients with malnutrition or those receiving chemotherapy and/or radiation or where there was tension at the anastomosis which were classified as "complicated anastomosis". Anastomotic leakage was observed in one patient (5%). The starvation period was 3.16 +/- 0.9 days compared to 3.46 +/- 1.0 days in the two layer technique "control" group. The rate of complications and the function of the GI tract in both non-complicated and complicated anastomoses after one layer continuous Polydioxanone anastomotic completion was not significantly different from those using conventional two layer anastomosis. The technique for one layer continuous suture is simple, easy and takes less time than the conventional method. This technique also theoretically provides better postoperative condition in which bowel anatomy and physiology can return to normal earlier, causing minimal tissue trauma, and less narrowing of the lumen although the evidence cannot be supported by this study. The Polydioxanone suture material is biodegraded by specific time, and hence allows normal growth of the anastomosed bowel; it is therefore suitable for both children and adults.

Absorption↗
PubMed1993

Presence of calcium in the vessel walls after end-to-end arterial anastomoses with polydioxanone and polypropylene sutures in growing dogs.

The presence of calcium in the vessel walls after end-to-end arterial anastomoses performed with polydioxanone and polypropylene interrupted sutures was studied in 140 anastomoses in 35 10-week-old German shepherd dogs. Histologic examination with hematoxylin and eosin, van Gieson, and von Kossa staining techniques was performed after the animals were killed 6 months after the operation. Ketamine hydrochloride was used as an anesthetic agent. At the start of the investigation the dogs weighed 14.5 +/- 2.6 kg (mean +/- standard deviation, n = 35), and after 6 months they weighed 45.3 +/- 3.1 kg (mean +/- standard deviation, n = 35). The diameter of the sutured arteries in the first operation was 2.6 +/- 0.5 mm (mean +/- standard deviation, n = 140). With each dog, both brachial and both femoral arteries were used--one artery for each different type of suture. In different dogs, different arteries were used for the same type of suture. The prevalence of calcifications after 6 months was determined from the numeric density of calcifications with standard stereologic techniques. The sutured and sutureless parts taken from longitudinal sections from each artery were studied, and t test values were calculated as follows: In paired samples, statistically significant differences in numerical density of calcifications were seen between sutured and sutureless arterial parts for both materials (sutureless part versus part with polydioxanone sutures, p < 0.001, n = 70; sutureless part versus part sutured with polypropylene sutures, p < 0.01, n = 70); however, in independent samples no statistically significant differences in numerical density of calcifications were seen between the polydioxanone and polypropylene groups for sutured (p > 0.05, n = 70) and sutureless parts (p > 0.05, n = 70).

Anastomosis, Surgical↗
PubMed1987

Arterial regeneration over polydioxanone prostheses in the rabbit.

We analyzed histologic, ultrastructural, and functional characteristics of rabbit aortic conduits regenerated over absorbable polydioxanone prostheses. Twenty-eight polydioxanone-elicited prosthesis/tissue complexes harvested two weeks to 12 months following implantation were analyzed grossly; photographed; sectioned for light, scanning, and transmission electron microscopy; and studied for compliance, bursting strength, and prostacyclin and thromboxane metabolite contents. No aortic-related deaths or hemorrhages occurred. Smooth regenerated conduits without stenoses were seen in 27 of 28 specimens, with one small aneurysm. Transprosthetic myofibroblast migration and proliferation paralleled the kinetics of macrophage-mediated prosthetic dissolution, which was consequently delayed compared with polyglycolic acid prostheses. Confluent endothelial-like luminal surfaces were present after two weeks. Progressive inner capsular thickening ended after three months at 420 micron. Ex vivo compliance curves resembled arterial elasticity. Regenerated tissue withstood 1200 mm Hg of systolic pressure, and 6-keto-prostaglandin F1 alpha to thromboxane B2 ratios did not differ from normal control specimens.

6-Ketoprostaglandin F1 alpha↗
PubMed2000

[Healing process of cartilage attached to a polydioxanone implant].

BACKGROUND AND OBJECTIVE: To correct severe septal deformities, it is often necessary to perform an extracorporal septoplasty with temporary removal of the deviated septal cartilage, followed by straightening and reimplantation into the nose as free graft. The utilization of a compound graft, which sutures the cartilage fragments to a resorbable polydioxanon (PDS) foil, facilitates this technique immediately while simultaneously ensuring support of the nasal dorsum. PATIENTS/METHODS: On account of the good clinical experiences (during the past 3 years 71 patients have been treated using this method), we investigated the biological properties of the foil and its degradation products in connection with cartilage in an animal model from a histological point of view. In five rabbits, a 0.15-mm-thick PDS foil was implanted in combination with the cartilage into the outer ear. The follow-up period was between 2 and 25 weeks. RESULTS: The results showed the following: (1) Up to the tenth week, the foil maintains the original structure; (2) The foil will be completely resorbed after 25 weeks; (3) The cartilage underneath the foil is protected from necrosis; (4) The degradation products of the polydioxanon do not interfere with the healing process; (5) Concerning the regeneration of cartilage, the foil acts as a guarding splint; (6) After resorption, almost no scar tissue remains. CONCLUSIONS: Due to the fact that the PDS foil endonasal implant means no additional risk to the patient, we can recommend the compound graft for simplification of extracorporal septoplasty.

Animals↗
PubMed2006

Polylactide (LTS) causes less inflammation response than polydioxanone (PDS): a meniscus repair model in sheep.

BACKGROUND: Incidence of meniscus injury has increased in today's active society. Arthroscopical refixation yields better results than partial meniscectomy. The best healing rates are achieved by sutures. As non-degradable sutures are permanent foreign bodies, slow absorbable materials are needed. A slow degradable suture with high concentration of polylactide acid, the so-called "long-term suture" (LTS, Panacryl), has been suggested to produce a higher inflammatory response than conventional polymer sutures [Vicryl, Dexon or polydioxanone (PDS)]. The aim of the study was to assess LTS for meniscus repair after a traumatic lesion and to evaluate immunological response, biodegradation and healing. METHODS: In 24 randomised sheep, a radial tear of the medial meniscus was sutured by either PDS or LTS. Twelve sham-operated animals served as control. Half of the sheep were killed after 6 months, the other half after 12 months. The medial and lateral meniscus, synovial membrane, articular cartilage and ascendant lymph nodes up to the kidney were examined. Joint effusion was evaluated by MRI. RESULTS: The synovial membrane was significantly thinner in the LTS group (6 months 85 +/- 10 microm, 1 year 100 +/- 28 microm) than in the PDS group (6 months 165 +/- 10 microm, 1 year 175 +/- 23 microm, P < 0.001) and the controls (6 months 150 +/- 17 microm, 12 months 192 +/- 21 microm, P < 0.001). The joint effusion was higher in the PDS than in the LTS group after 6 months, and tended to be higher in controls. In controls, effusion tended to be higher than in the LTS group. In all medial departments, osteoarthritis evolved much more intensely than in the lateral knee departments (P < 0.01). Bilateral lymph nodes from the groin up to the kidneys were larger (crosscut area) after 6 months in the controls (2.28 +/- 0.7 mm(2)) and PDS treated animals (2.3 +/- 0.7 mm(2)) than in the LTS group (1.3 +/- 0.3 mm(2), P < 0.001). After 1 year, node size differed significantly between controls and animals from the LTS group (1.98 +/- 0.4 mm(2) vs. 1.5 +/- 0.2 mm(2), P < 0.05), and between animals from the PDS and the LTS group (2.5 +/- 0.1 mm(2) vs. 1.5 +/- 0.2 mm(2), P < 0.001). CONCLUSION: The polylactide thread LTS causes less immunological reaction and synovitis than a polydioxanone suture (PDS). CLINICAL RELEVANCE: LTS may serve as an alternative to PDS for repair of slow healing structures such as tendons and menisci.

Absorbable Implants↗
PubMed1985

Adhesion formation and histologic reaction with polydioxanone and polyglactin suture.

A suture material associated with a minimal inflammatory response might be expected to induce less frequent and less severe peritoneal adhesions. A comparison between polydioxanone and polyglactin 910 suture was performed in a rabbit model. Ten sexually mature virgin female New Zealand white rabbits underwent laparotomy and bilateral incisions into the distal uterine cavities. The serosa of the left uterine horn was always reapproximated with polyglactin 910 suture whereas the right uterine horn was repaired with polydioxanone suture. All animals were put to death 28 days later. An adhesion score was given for each uterine horn. Representative sections were obtained for histologic review. Similar histologic responses were found in both groups. No significant difference was noted in adhesion scores between the two sutures. The present study cannot justify the use of one of these sutures over the other with regard to adhesion formation or tissue reaction.

Animals↗
PubMed1996

Suture reaction following skin closure with subcuticular polydioxanone in total knee arthroplasty.

A retrospective study revealed a 20% incidence of suture reaction following closure of wounds with subcuticular polydioxanone after total knee arthroplasty. In a control group whose wounds were closed with subcuticular polyglycolic acid (Dexon, Davis & Geck, Wayne, NJ), no suture reactions occurred (P = .0012, Fisher's exact test). It is concluded that subcuticular polydioxanone should not be used for skin closure after total knee arthroplasty.

Abscess↗
PubMed2001

Cell seeded decellularised allogeneic matrix grafts and biodegradable polydioxanone-prostheses compared with arterial autografts in a porcine model.

BACKGROUND: small diameter vascular grafts are limited by their restricted availability, early thrombosis, and requirement for anticoagulants. OBJECTIVE: to evaluate different approaches to biocompatible vascular grafts. METHODS: sixteen allogeneic acellularised arteries seeded with autologous endothelial cells were implanted to replace a segment of the common carotid artery (group I). Other animals received polydioxanone prostheses (group II: inner diameter, i.d. 4 mm, n=18; group III, i.d. 5 mm, n=20) or arterial autografts (group IV, n=8). Graft patency was evaluated by means of ultrasound duplex scanning, angiography and histology. RESULTS: patency was 54% (71%), 17% (0%), 50% (50%), and 100% (100%) in group I, II, III, and IV after 1 week (4 months), respectively. Significant differences (p<0.05) were found for group IV versus all other groups at 1 week, as well as for group IV versus groups II and III, for group II versus III, and group I versus II at 4 months. CONCLUSION: small diameter vascular grafts can be engineered from an acellular allogeneic matrix seeded with autologous cells. Patency is superior to polydioxanone prostheses but inferior to the arterial autograft.

Animals↗
PubMed1999

Comparison of polydioxanone (PDS) and polypropylene (Prolene) for Shouldice repair of primary inguinal hernias: a prospective randomised trial.

OBJECTIVE: To compare the recurrence rates after Shouldice operation for primary inguinal hernias, using non-absorbable polypropylene or absorbable polydioxanone suture material. DESIGN: Randomised, controlled trial. SETTING: Teaching hospital, Germany. SUBJECTS: 220 male patients who had 233 elective Shouldice repairs of primary inguinal hernias, 201 of whom were followed up. INTERVENTION: Standard Shouldice procedure with 2/0 polypropylene (Prolene, n = 98) or 2/0 polydioxanone (PDS, n = 103). MAIN OUTCOME MEASURES: Recurrence rates after a minimum follow-up of 24 months (range 24-48, mean 31). RESULTS: Numbers of early complications were similar in the two groups; there were 2 wound infections in each. A total of 193 patients with 201 repairs had a documented follow-up (86%). There were 6 recurrences in the PDS group and 5 in the Prolene group, giving a total recurrence rate of 5%. This difference was not significant (Fisher's exact test, p = 1.0). CONCLUSION: Recurrence rates in both groups were higher than expected, but there was no difference between the two groups.

Absorbable Implants↗