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PubMedDate not supplied

[Tension fixation of rupture of the symphysis with woven polydioxanone sutures].

In seven patients (mean age 22 years) with injuries of the pelvic ring, the rupture of the symphysis was treated by polydioxanone ligaments. Complete rupture of the ileosacral joint was treated twice by additional external fixation, twice a compression screw osteosynthesis was applied. Incomplete iliosacral rupture in another three cases was not operated. Patients were treated functionally without signs of loosening or instability. After a control examination after 5 months all patients were free of symptoms in the area of the symphysis. Infection of the operation area did not accur. In our opinion the advantages of this method are simple operative technique, reduced risk of infection and no need for removal of metallic implants. Our excellent initial experience with synthetic PDS ligaments in operative treatment of symphysis ruptur seem to justify its application for other injuries like iliosacral or acromioclavicular rupture.

Adolescent↗
PubMed1999

Evaluation of expanded polytetrafluoroethylene (ePTFE) versus polydioxanone (PDS) for the repair of dura mater defects.

A comparative animal experimental study was performed to test the potential application of expanded polytetrafluoroethylene (ePTFE) vs. polydioxanone (PDS) as dural substitutes. Sixty male Sprague-Dawley rats underwent a right frontoparietal craniotomy, opening of the dura mater, and a small cortical lesion. The dural defect was covered with a piece of ePTFE or PDS. Animals were sacrificed at 30 days or 90 days. Following decalcification, heads including scalp, skull, and underlying brain were sectioned, stained with hematoxylin-eosin, and histologically analyzed. Dural defects repaired with ePTFE, showed minimal reactive changes and no adhesions to the brain surface. No foreign body type giant cell reaction was seen, and the graft became enclosed in a thin sheet of connective tissue. Dural defects repaired with PDS, showed some giant cell infiltration and ingrowth of collagen fibers. Both substitutes provided satisfactory biological function and biocompatibility. Expanded PTFE advantages included relative suppression of tissue ingrowth, ensheathment by connective tissue, and a high tearing strength. Although both materials show promise for use in dural grafting, further clinical studies are necessary to determine their potential applications as a human dural substitute.

Animals↗
PubMed1992

Demineralized bone matrix polydioxanone composite as a substitute for bone graft: a comparative study in rats.

Demineralized bone matrix (DBM) has been successfully used as a substitute for bone grafting. Autogenous bone grafts (ABG) may cause donor site morbidity and undergo significant resorption. DBM may overcome these problems but is mechanically unstable when originally placed. We explored using a slowly resorbable template, polydioxanone (PDS), in combination with DBM and compared it to ABG in a rat 9 x 9 mm cranial defect model. After both 1 and 3 months, histologically and biochemically well-formed bone was present in ABG/PDS and DBM/PDS-treated defects, but not in control defects (PDS alone). Mechanical push-out tests using a servohydraulic testing frame were conducted. Maximum load before failure of DBM/PDS increased from 65% at 1 month to 100% of that of intact skull at 3 months. In contrast, ABG/PDS was 50% as strong as DBM/PDS and not significantly stronger than PDS alone. ABG/DBM did not significantly increase in strength from 1 to 3 months. We conclude that DBM/PDS is better than ABG/PDS in treating cranial defects in the rat model, and that an absorbable osteoinductive bone substitute with superior mechanical advantage is possible without the disadvantages of ABG.

Animals↗
PubMed1983

Clinical experience with polydioxanone monofilament absorbable sutures in plastic surgery.

Various sizes of undyed monofilament polydioxanone surgical suture were assessed in 52 surgical patients who underwent plastic surgery. With a single exception, follow-up observations were carried out for at least 40 days. Clinical results were judged satisfactory in 13 patients and excellent in 39 patients. The suture was found significantly better than gut in terms of pliability, ease of passage through tissue, ease of tying, strength, fray resistance, and overall handling properties. The undyed suture material tested in this study was rated as having inferior visibility when compared with surgical gut. This new suture material, the first synthetic absorbable available as a monofilament, would appear to be particularly useful in situations requiring extended wound support, in potentially infected wounds in which a monofilament suture would have lessened tendency to harbor pathogenic bacteria, and in cases where ease of passage through tissue, smooth tie-down, and precise knot placement are important.

Absorption↗
PubMedDate not supplied

Biodegradation of polydioxanone in bone tissue: effect on the epiphyseal plate in immature rabbits.

Implants of polydioxanone (PDS), 1.3 mm in diameter, were operatively fixed in the juxta-epiphyseal area of the right proximal tibial metaphysis in six rabbits and were driven into a drill hole of equal bore through the right proximal tibial epiphyseal plate in ten rabbits. The PDS implants had biodegraded almost completely in cortical bone at 16 weeks without any significant sign of inflammation or foreign body reaction. The PDS implants did not cause any growth disturbance. Histologic studies, however, showed that seven of 10 rabbits demonstrated significant osseous bridge formation across the epiphyseal plate.

Animals↗
PubMed1991

Imaging properties of polydioxanone and titanium ligating clips following para-aortic lymphadenectomy for testicular cancer.

Stainless steel ligating clips produce serious artefacts on CT scans. Polydioxanone (PDS) and titanium ligating clips were used in 15 patients during para-aortic lymphadenectomy for residual metastatic testicular teratoma following chemotherapy, and follow-up CT images were compared with those following the use of stainless steel ligating clips. PDS ligating clips did not produce any artefacts and were progressively absorbed. Titanium ligating clips produced artefacts similar to but less intense than those of stainless steel. PDS ligating clips should be used when follow-up CT scanning is important.

Constriction↗
PubMed2005

Comparison of two absorbable monofilament polydioxanone threads in intradermal buried sutures.

BACKGROUND AND OBJECTIVES: Two absorbable polydioxanone threads are compared regarding intraoperative handling qualities, scar dehiscence, and possible side effects. METHODS: In 30 excisions, half of each suture was performed with PDS II (Ethicon GmbH, Norderstedt, Germany), whereas the other half was closed with Serasynth (Serag-Wiessner, Naila, Germany). Clinical evaluation for scar spreading, spitting of the sutures, hypertrophic scarring, or suture granuloma was performed 3 and 6 months after surgery. RESULTS: No significant difference in scar spreading, hypertrophic scarring, or the incidence of suture granuloma was noted. A significantly lower frequency of spitting was seen with Serasynth than with PDS. The handling and suturing properties of SerasynthM were estimated to be slightly superior compared with those of PDS. CONCLUSION: Our study shows that PDS and Serasynth provide equal cosmetic results when applied in an appropriate suturing technique. Possibly owing to its better pliability, the frequency of spitting was lower with Serasynth.

Absorbable Implants↗
PubMedDate not supplied

Polydioxanone sternal sutures for prevention of sternal dehiscence.

BACKGROUND: Sternal dehiscence and wound instability are troublesome complications following median sternotomy. Classic sternal approximation with stainless steel wires may not be the ideal approach in patients predisposed to these complications. We tested the efficacy of polydioxanone (PDS) suture in sternal closure and in prevention of complications in comparison to steel wires in high-risk individuals. METHODS: Three hundred sixty-six patients undergoing elective cardiac surgery with full median sternotomy and having body surface area (BSA) less than 1.5 m(2) were randomly assigned to receive PDS (n = 181) or stainless steel (SS, n = 185) sternal approximation. The study was focused on aseptic sternal complications, namely bone dehiscence and superficial wound instability. RESULTS: Both bone dehiscence and superficial wound instability were less frequent in the PDS Group (4 and 3 cases in the SS Group, respectively, vs. no cases in the PDS Group). Cox proportional hazards regression model in the whole study population identified female sex, chronic renal insufficiency, diabetes, advanced age, lower sternal thickness, osteoporosis, corticosteroid therapy, and prolonged CPB or ventilation times as predisposing factors to any of the two studied sternal complications. DISCUSSION: Data suggest that PDS suture can protect against development of aseptic sternal complications following median sternotomy in high-risk patients with little body mass. The adoption of PDS in other subsets of patients, i.e., obese individuals, is to be questioned.

Aged↗
PubMed1985

Biological tolerance to polydioxanone absorbable clips: a comparison with metallic ligating clips.

An experiment was conducted in 96 rats to determine the tissue tolerance to a hemostatic and absorbable clip made of polydioxanone, as compared to standard metallic clips. Clinical tolerance was similar and no bleeding or death occurred because of the material. Pathological studies showed a mild histiocytic reaction with absorbable clips and a stronger inflammatory reaction with metallic clips. This experiment indicates that absorbable clips are efficient and well tolerated and we strongly recommend the use of this material.

Absorption↗
PubMed1981

PDS (polydioxanone suture): a new synthetic absorbable suture in cataract surgery. A preliminary study.

PDS (polydioxanone suture), a new synthetic absorbable suture, was used in 21 patients undergoing cataract surgery. It still retains 25% of its tensile strength at 42 days but absorption takes 130-180 days. 1 braided coated and 1 monofilament PDS were adequate as conjunctival sutures but offered no advantage over available materials. 0.5 monofilament PDS was superior in handling qualities to 0.4 virgin silk. It does not need to be removed but retains tensile strength for longer than other absorbable sutures.

Aged↗
PubMed1988

Experimental and clinical investigations on the suitability of polydioxanone threads for cerclage of the eyeball.

Absorbable polydioxanone (PDS; Ethicon) threads were used for cerclage of the eyeball. Experimental investigations on rabbits have proved that PDS is well tolerated by surrounding eye tissues, does not cause any side effects, and has a sufficiently long time of absorption to ensure chorioretinal cicatrization. 81.25% of reattachments were achieved in humans after the first operations, and 87.5% after the second operation. The authors conclude that PDS is good ocular cerclage material, but we would prefer it in the shape of a band.

Adolescent↗
PubMed1992

Fixation of osteochondral fractures in rabbit knees. A comparison of Kirschner wires, fibrin sealant, and polydioxanone pins.

We compared fibrin sealant, polydioxanone (PDS) pins and Kirschner wires in the fixation of osteochondral fractures in rabbit knees. Standardised osteochondral fractures of the right medial femoral condyle were made in 56 adult New Zealand white rabbits. There were equal groups of control knees, and those which had Kirschner-wire, fibrin-sealant or PDS-pin fixation. No external immobilisation was used. One animal from each group was killed at two, three and four weeks. The remaining rabbits were killed at six weeks. A fracture which healed with less than 1 mm of displacement was considered a success. There was successful healing in 29% of the control group, in all of the Kirschner-wire group, in 50% of the fibrin-sealant group, and in 86% of the PDS-pin group. The use of PDS pins appears to be a reliable alternative to the use of metal in the fixation of osteochondral fractures in rabbits.

Animals↗
PubMed2004

Arthroscopic reattachment of osteochondritis dissecans lesions using resorbable polydioxanone pins.

REASONS FOR PERFORMING STUDY: Debridement of osteochondritis dissecans (OCD) cartilage lesions results in fibrocartilage and imperfect hyaline repair tissue, and forms a permanent irregularity to the subchondral bone plate. OBJECTIVE: To evaluate the clinical, radiographic and outcome effects of OCD cartilage flap reattachment for select lesions as an alternative to OCD debridement. HYPOTHESIS: Separated cartilage flaps resulting from OCD lesions may be re-incorporated into the hyaline cartilage surface by reattachment rather than debridement and removal. METHODS: Resorbable polydioxanone pins were used to reattach OCD flap lesions in 16 joints of 12 horses. Criteria for attachment, rather than removal, included an unmineralised cartilage flap on preoperative radiographs and a relatively smooth surface with some residual perimeter attachment at surgery. RESULTS: There were 12 subjects, 6 males and 6 females, 7 Thoroughbred or Standardbred weanlings, 3 Warmbloods, 1 Arabian and 1 Quarter Horse, mean age at surgery 6.8 months. All horses had effusion of the affected femoropatellar joint (n = 9), tarsocrural joint (n = 1) or fetlock (n = 2). Radiographic lesions varied in length between 1.8-6.3 cm; reattachment was used in 16 of 18 affected joints and the OCD cartilage was not satisfactory for salvage in 2 stifles. Number of pins required was 2-10. One horse was subjected to euthanasia due to a tendon laceration 8 weeks after surgery; of the remaining 11 horses, mean duration of follow-up was 3.9 years (range 4 months-8 years). Nine of these were sound and had entered work, while 2 were sound but remained unbroken 4 and 6 months post operatively, respectively. Radiographic resolution of the OCD lesion occurred in 14 of 16 pinned joints in the 9 horses with long-term follow-up. The 2 remaining joints had a 3 and a 5 mm mineralised flap in the original defect sites. CONCLUSIONS: This study indicated cartilage flap reattachment was an alternative to removal in selected OCD lesions. POTENTIAL RELEVANCE: Relatively smooth OCD cartilage flaps may be salvaged by reattachment and can result in normal radiographic subchondral contour and a high likelihood of athletic performance. Further case numbers are required to determine which lesions are too irregular or contain too much mineral for effective incorporation after reattachment.

Animals↗
PubMed1987

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↗
PubMed1999

[Our experience with the use of Absolok polydioxanone resorbable clips in laparoscopic surgery].

BACKGROUND: The study aims to evaluate the efficacy of resorbable clips in polydioxanone in laparoscopic surgery. METHODS: The authors report their personal experience regarding the use of Absolok (ABL) resorbable clips in laparoscopic surgery. Out of a total of 745 laparoscopic operations performed from September 1992 to February 1997, 438 included the use of resorbable clips in place of metal clips, both for cystic duct section during cholecystectomy and vascular structures, or to lock continuous sutures. ABL clips were also used for major vessels (e.g. mesenteric artery) during laparoscopic colic resections. RESULTS: In all cases when they were used, ABL never gave rise to complications, such as biliary outflow or hemorrhage caused by the dislocation of the clips themselves. CONCLUSIONS: The authors conclude by affirming the value and safety of this type of clip.

Humans↗
PubMed2002

Medical devices: reclassification and codification of the absorbable polydioxanone surgical suture. Final rule.

The Food and Drug Administration (FDA) is announcing that it has issued an order in the form of a letter to Ethicon, Inc., reclassifying the absorbable polydioxanone surgical (PDS) suture intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery, from class III (premarket approval) to class II (special controls). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled "Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA," which is immediately in effect as the special control for the PDS suture, but remains subject to public comment and possible future revision under the agency's good guidance practices. The agency is reclassifying this device into class II because new information supplied by the petitioner indicates that special controls, in addition to general controls, will provide reasonable assurance of the safety and effectiveness of the device, and there is sufficient information to establish special controls. Accordingly, the order is being codified in the Code of Federal Regulations. Any firm submitting a premarket notification (510(k)) for a new PDS suture will need to address the issues covered in the special control guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness.

Device Approval↗
PubMed1991

[Continuous intestinal suture with polydioxanone].

Within five years a total of 264 anastomoses were performed on 241 patients in a continuous extramucosal single-layer end-on suture technique with polydioxanone. In 133 small bowel, and 131 colonic anastomoses there were no leakages as the only complications attributable to the procedure. Both anastomotic failures occurred after colonic resections, for a 1.5% dehiscence rate. Small bowel anastomoses healed without complications.

Anastomosis, Surgical↗