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Calcinosis circumscripta associated with polydioxanone suture in two young dogs.

Calcinosis circumscripta associated with polydioxanone suture material was diagnosed in two young dogs. In each case, the owner noticed a firm mass at the site of a previous surgical incision. Mineralization of soft tissues was visible radiographically. At excision, multiple chalky white nodular masses within the subcutis extended in a linear pattern the length of the sutured incision, but not beyond it. Polydioxanone suture was identified within the center of the nodules, which were identified histologically as calcinosis circumscripta.

Animals↗

An in vitro biomechanical comparison of the breaking strength and stiffness of polydioxanone (sizes 2, 7) and polyglactin 910 (sizes 3, 6) in the equine linea alba.

OBJECTIVE: To determine failure strength, stiffness, and failure mode of 4 suture materials in equine linea alba. STUDY DESIGN: Randomized complete block design. SAMPLE POPULATION: Linea albas collected from 12 adult horses (mean weight, 475 kg; mean age, 10 years). METHODS: The ventral abdominal fascia, including the linea alba, was collected and bisected along the linea alba into right and left halves. Each half was divided into four, 5-cm sections extending from the umbilicus cranially, and randomly assigned to 1 of 4 suture materials: 2 polydioxanone (2 PD), 3 polyglactin 910 (3 PG), 6 polyglactin 910 (6 PG), and 7 polydioxanone (7 PD). A single cycle to failure test was performed on each specimen at a distraction rate of 100 mm/min. Differences in failure strength and stiffness for the materials were evaluated using a mixed linear model with significance set at P<.05. RESULTS: In 94 of 96 test sections, constructs failed by suture failure. There were significant differences in failure strength (P<.0001) and stiffness (P<.001) among the suture/tissue constructs. 7 PD had the highest breaking strength (316.8 N) followed by 6 PG (281.3 N), 3 PG (229.9 N), and 2 PD (193.0 N). Six PG had the largest stiffness (14 N/mm) followed by 3 PG (12.7 N/mm), 7 PD (10.1 N/mm), and 2 PD (7.2 N/mm). Suture breaking strength and stiffness were not affected by linea or fascia thickness, individual horse, half of the linea alba, or abdominal wall position. Eighty-five (90.4%) suture loops failed adjacent the knot. CONCLUSIONS: When tested in single cycle to failure, suture material was more likely to fail than the linea alba. Larger suture materials had higher breaking strengths than smaller suture materials and stiffness was also affected by suture material and size. CLINICAL RELEVANCE: Given its high initial breaking strength and its relatively longer in vivo strength retention, 7 PD seems an appropriate choice of suture material for closure of the equine linea alba when maximal short-term failure strength is desired.

Abdominal Muscles↗

Fixation of the Chevron osteotomy utilizing absorbable polydioxanon pins.

The Chevron osteotomy has become popular for the treatment of hallux valgus deformity. Displacement of the osteotomy is a known complication. Many methods of internal fixation have previously been reported to prevent the displacement and each has inherent advantages and disadvantages. An alternative method of fixation, utilizing absorbable polydioxanon pins, is presented in this article. Between April 1989 and April 1990, 71 procedures were performed on 50 patients. At 1-year follow-up, there were no complications or infections. Review of the osteotomy after surgery and at 1 year revealed no fractures or displacements, and no pins required removal. Internal fixation utilizing absorbable polydioxanon pins appears to have significant benefits when compared with metallic fixation.

Adult↗

Polydioxanone biodegradable pins in the knee: MR imaging.

OBJECTIVE: Biodegradable solid implants have been developed as an alternative to metallic orthopedic fixation. In animal models, implants degrade within and are replaced by bone. This study documents the resorption of these devices in human patients with MR imaging. SUBJECTS AND METHODS: One hundred seventy-five 1.3-mm biodegradable pins made of polydioxanone were used to secure a total of 59 osteochondral allografts of the knee. Patients with the pins underwent scanning on a 1.5-T unit with 3.3- to 4-mm contiguous T1-weighted spin-echo (TR/TE, 600/15), fat-saturated proton density-weighted (3000/40), T2-weighted fast spin-echo (3000/63), and three-dimensional spoiled gradient-recalled (47/7; flip angle, 60 degrees ) sequences at 3, 6, 12, 24, or 36 months after surgery. Eighty-nine pins were imaged on multiple occasions. Two osteoradiologists interpreted the MR examinations. RESULTS: More than 80% of the pin channels were visible at 3 and at 6 months after surgery. By 24 months, only 20% of the pin channels were visible, with the remainder having been replaced by bone. At 3 months, nearly 40% of the pins were associated with adjacent marrow edema. Edema generally diminished, involving less than 20% of pins at later time points. Focal cartilage defects were evident at 32% of the pin insertion sites during the first 6 months, but these defects were present in only 4% of the insertion sites thereafter. CONCLUSION: Biodegradable polydioxanone pins usually resorb completely by 24 months. Marrow edema, presumably representing inflammation related to pin resorption, is infrequent and tends to resolve. Cartilage defects related to pin placement heal spontaneously.

Absorbable Implants↗

[Initial results following implantation of resorbable micro-patches of polydioxanone in the rat aorta].

Polydioxanon micro-patches were inserted into the infrarenal aorta of 21 rats by means of microsurgical techniques. Histologic characteristics were analysed by light microscopy up to 8 weeks after implantation. The following observations were made: After 4 weeks a regenerated artery with different layers could be seen: Neo-Endothelium-, Neo-Media-, Neo-Adventitia-Patch-layer. Two different proliferation zones were evaluated: the anastomotic adventitial layer, responsible for regenerating the Neo-Adventitia-Patch-layer as a chronic foreign body reaction, the anastomotic intima layer, responsible for regenerating the Neo-Media with differentiation of cells into smooth-muscle-like cells. The lining cells appeared like endothelium-like cells. These study demonstrates the possibility of regenerating arterial tissue over polydioxanon patch in the rat aorta.

Animals↗

Abdominal wound closure: a controlled trial of polyamide (nylon) and polydioxanone suture (PDS).

Two hundred and thirty three patients with major laparotomy wounds, either midline or transverse, were randomly allocated to mass closure using No 1 (BPC) polyamide (Nylon) or polydioxanone suture (PDS). Wounds were assessed during the hospital stay and postoperatively in outpatients, at six weeks and six months, for evidence of wound failure or wound infection. Two wound failures occurred in the PDS group (one burst abdomen and one incisional hernia) although neither was directly attributable to suture failure. The overall wound infection rate was 13.3%; 2.9% being major infections and the majority (two thirds) occurring in the PDS group. There were no reported wound sinuses or wound pain in either group at six months. Polydioxanone suture may be an alternative to polyamide for laparotomy closure but is associated with a higher, though not statistically significant, incidence of wound failure and infection.

Adult↗

Polydioxanone suture material in growing vascular anastomoses. Experimental study.

We studied the growth of vascular anastomoses after use of absorbable suture material in 21 piglets. In six piglets, end-to-end anastomosis of the infrarenal aorta was performed with 5-0 continuous polypropylene suture; stenosis developed in two of these animals. In 15 piglets, continuous polydioxanone sutures were used for the anastomoses, and no stenosis developed. On the contrary, 14 of these anastomoses showed some degree of dilation at the anastomotic site. Burst testing to 300 mm Hg caused no disruption. On histologic examination, only scar tissue at media and intima with good degree of differentiation was noted. Growth of a vascular anastomosis after use of absorbable polydioxanone suture material seems to be perfectly possible without stricture formation. Because the growing process takes years instead of months in human beings, with obviously less stress at the anastomotic site, it is likely that dilatation at the level of the suture line will not occur in clinical use.

Animals↗

Abdominal wound closure. A comparison of polydioxanone, polypropylene, and Teflon-coated braided Dacron sutures.

A midline abdominal wound was made in 135 Harlan Sprague-Dawley rats, and the fascia was then closed by the continuous suture technique with 4-0 absorbable monofilament polydioxanone sutures (n = 45 rats), 4-0 permanent monofilament polypropylene sutures (n = 45 rats), or 4-0 Teflon-coated braided Dacron sutures (n = 45 rats). At 1-, 2-, and 6-month intervals, wound-bursting pressures were determined in 15 animals from each group. At 1 month and at 6 months, there was no significant difference in wound-bursting strength among the three types of sutures. At 2 months, wounds closed with Teflon-coated braided Dacron were significantly stronger than wounds closed with the other types of sutures. In most of the braided Dacron suture animals, the fascia burst in areas other than the abdominal wound, indicating that the wound was stronger at that time than was the surrounding fascia. There is no advantage to that added strength, and braided Dacron sutures have been shown to cause greater tissue reaction than monofilament sutures. Therefore, except in patients with poor wound healing who are highly susceptible to dehiscence and in whom permanent low-tissue-reaction sutures may be beneficial, the authors recommend a running suture technique using absorbable monofilament suture, such as polydioxanone, for the routine closure of clean abdominal wounds.

Abdomen↗

9-O monofilament polydioxanone (PDS): a new synthetic absorbable suture for cataract wound closure.

This study describes the intraoperative and postoperative performance of 9-O monofilament Polydioxanone (PDS) suture for cataract wound closure. This newly developed synthetic absorbable suture is designed to meet the need for a "long-term" absorbable suture material suitable for cataract wound closure following intraocular lens implantation. Polydioxanone's advantages over currently used "short-term" absorbables and biodegradable nylon are described in this report.

Cataract Extraction↗

[Reconstruction of the orbit floor using a resorbable polydioxanone (PDS degree) cup. Analysis of a series of 71 cases].

A 71 patients series is presented, concerning primary orbital floor reconstruction by a polydioxanone cup (PDS degree) which has been used for five years. The technical data and surgical procedure are exposed. No infection either intolerance manifestation has been observed until the materiel was resorbed. Two early displacements of the implant are reported, due to a technical fault during the insertion of the cup. Only one late enophtalmy was observed for a patient with a large orbital floor defect. The loss a the rigidity of the polydioxanone seems to be relatively fast (probably 2-3 months) and leads to contraindicate its use in cases of large osseous traumatic defects. In all other cases, this surgical technique seems to be very useful.

Adolescent↗

Influence of polydioxanone foil on growing septal cartilage after surgery in an animal model: new aspects of cartilage healing and regeneration (preliminary results).

OBJECTIVE: To determine whether late complications after septoplasty in growing septal cartilage in children can be prevented by the use of a resorbable polydioxanone (PDS) foil in combination with the cartilage. DESIGN: Animal study with 45 young rabbits, operated on at the nasal septum. Four typical septoplasty procedures were carried out, including elevation of the mucoperichondrium, cartilage excision, and reimplantation of crushed and noncrushed cartilage; for each of the procedures, resorbable PDS foil was used in half of the animals. Observation time ranged from 2 weeks to 5 months, to observe the healing process until complete outgrowth of the septum and complete resorption of the foil were achieved. SETTING: Ear, Nose, and Throat Department at University of Pécs, Pécs, Hungary. MAIN OUTCOME MEASURE: Histomorphologic findings on specimens of septum stained with hematoxylin-eosin and periodic acid-Schiff stains. RESULTS: Depending on the surgical procedure, there were various degrees of differences between the groups with and without PDS. After elevation of the mucoperichondrium, there were almost no differences between the 2 groups. After cartilage resection, reimplantation, and crushing, however, there was a remarkable difference between groups. In the group without PDS, septal deviations and poorly regenerated cartilage were observed, but in the group with PDS no significant deviation after complete regeneration of septal cartilage was observed. CONCLUSIONS: The resorbable PDS foil prevented a secondary deviation in the surgically treated growing septal cartilage in young rabbits. Use of this foil could reduce late complications such as septal deviations and possibly prevent growth inhibition in the growing nasal septum after septoplasty.

Animals↗

Closure of abdominal wounds with polydioxanone. A prospective study.

Polydioxanone, an absorbable synthetic monofilament suture, was used to close abdominal wounds in 200 consecutive operative procedures. All patients were followed up for one year. Despite a high incidence of risk factors for impaired wound healing, the incidence of dehiscence and evisceration was zero; incisional hernia occurred in 2.9% of vertical midline wounds and in 3.6% of transverse incisions. This new suture material is safe and effective for closure of abdominal wounds.

Abdominal Muscles↗

Physeal response to absorbable polydioxanone bone pins in growing rabbits.

Absorbable fixation materials would seem especially useful for treating transphyseal fractures in growing children, but their degradation products may affect physeal growth. The histologic response of an open physis to placement of transphyseal, polydioxanone (PDS), bioabsorbable pins was studied in skeletally immature New Zealand White rabbits. A 1.3-mm PDS pin was inserted across the right femoral physis, and a 1.3-mm empty drill hole across the left femoral physis served as a control. The animals were sacrificed at 3, 6, 9, and 12 weeks postsurgery. Biplanar radiographs, bone length measurements, and histology sections of the physis and adjacent bone were made. Three independent observers graded the histologic response of the physis to the drilling and implant. There was no evidence of inflammation, foreign body reaction, or distortion of the growth plate during the entire growth period. This suggests bioabsorbable pins do not cause any appreciable inflammatory response or adverse effect on physeal function during active longitudinal growth of the bone.

Animals↗

Polydioxanone or polypropylene for closure of midline abdominal incisions: a prospective comparative clinical trial.

Seven hundred and fifty-seven consecutive patients undergoing a midline abdominal incision were stratified according to age, sex, type of operation and degree of operative contamination and were randomly allocated to mass closure of the abdominal wall with continuous 4 metric polydioxanone (PDX; 374 patients) or continuous 4 metric polypropylene (PPL; 383 patients). Wound infection was less common with PDX (PDX 3.5 per cent; PPL 7.0 per cent; P less than 0.05) and there was one dehiscence in each group. The incidence of defective wounds in patients surviving 1 year was similar (7.7 per cent PDX; 9.7 per cent PPL) but the PPL suture had to be removed because of persisting wound pain or sinus formation in five patients. PDX is the preferred suture material for closure of midline abdominal incisions.

Clinical Trials as Topic↗

The hydrolytic degradation of polydioxanone (PDSII) sutures. Part I: Morphological aspects.

The morphological changes in polydioxanone sutures (PDSII), and the resulting changes in properties are explored as a function of in vitro degradation time with the use of small- and wide-angle x-ray scattering, optical microscopy, differential scanning calorimetry, dynamic mechanical thermal analysis, and measurements of tensile properties and mass change. There are significant changes to the properties of the suture on initial hydration. In the time range of 0-80 days investigated, two subsequent stages of degradation are apparent. Chain scission is thought to occur in the first stage, beginning as soon as the chains become hydrated. However, in this stage, the effects of scission on the physical properties of the suture are not apparent. The transition from the first (dormant) stage to the second (active) stage, in which changes to the physical structure and mechanical properties of the fiber become measurable, is gradual, with the first change occurring after about 15 days. The relationships between the changes in the microstructure and the properties are discussed and a general model for the degradation process proposed.

Biodegradation, Environmental↗

The hydrolytic degradation of polydioxanone (PDSII) sutures. Part II: Micromechanisms of deformation.

An investigation of morphological changes in hydrolytically degraded polydioxanone sutures (PDSII) during in situ tensile deformation is reported. These changes were followed with the use of real-time small-angle X-ray scattering with simultaneous tensile deformation experiments. The results are correlated with separately performed wide-angle X-ray scattering, and optical microscopy experiments on the effects of tensile strain. Interlamellar and interfibrillar amorphous regions appear to control the microdeformation and the shape of the stress-strain curves of PDSII sutures. The fibers deform initially by interlamellar separation and at larger strains by fibrillar slip. Fractures appear to be caused by the catastrophic growth of cracks. The degradation of interlamellar tie chains in PDSII sutures does not appear to significantly affect the progress of deformation, because deformation through interlamellar separation is largely unchanged by degradation. Conversely, hydration and scission of interfibrillar tie chains lowers the load required to propagate interfibrillar shear. The fibers fail at progressively lower strains as degradation proceeds.

Biodegradation, Environmental↗

Tissue response to polyglycolide, polydioxanone, polylevolactide, and metallic pins in cancellous bone: An experimental study on rabbits.

The purpose of this study was to investigate, qualitatively and histoquantitatively, the tissue response of rabbit femur cancellous bone to polyglycolide (PGA), polydioxanone (PDS), polylevolactide (PLLA), and stainless steel pins under identical conditions. Eighty knees in 50 rabbits were operated on by inserting bioabsorbable pins (PGA, PDS, or PLLA) together with metallic Kirschner wire in 60, and two metallic Kirschner wires alone in 20 knees, while 20 knees served as intact controls. Follow-up times were 3, 6, 12, 24, and 52 weeks. Cancellous bone tissue response to implants was studied using histological, histomorphometrical, microradiographical, and oxytetracycline fluorescence methods. Residual fragments of PGA and PDS were seen at 24 weeks. Complete degradation of these polymers had taken place before 52 weeks. No signs of degradation of the PLLA pins were observed within the entire follow-up period. The osteoid formation surfaces at tissue implant-interface were statistically larger in all test groups as compared to intact controls. The number of macrophages at tissue implant-interfaces increased in all bioabsorbable implant specimens until 6 weeks, and with PGA until 12 weeks. No differences in the osseous response emerged when comparing groups of bioabsorbable implants with each other or with stainless steel group. Bioabsorbable pins and metallic Kirschner wires evoked an osteoconductive response in the cancellous bone surrounding implant, but the response intensity between implants displayed no differences. This suggests a simple, nonspecific walling-off new-bone front type of response. Consequently, the polymers possessed no specific osteostimulatory or osteoinhibitory properties. Within the follow-up, no significant differences in biocompatibility between the implants appeared, and no frank inflammatory foreign-body reactions occurred. The small-volume pins obviously did not exceed the local tissue tolerance and clearing capacity of the bone.

Absorbable Implants↗

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↗