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PubMed2005

Mechanical properties and in vitro degradation of bioresorbable fibers and expandable fiber-based stents.

Bioresorbable polymeric support devices (stents) are being developed in order to improve the biocompatibility and drug reservoir capacity of metal stents, as well as to offer a temporary alternative to permanent metallic stents. These temporary devices may be utilized for coronary, urethral, tracheal, and other applications. The present study focuses on the mechanical properties of bioresorbable fibers as well as stents developed from these fibers. Fibers made of poly(L-lactide) (PLLA), polydioxanone (PDS), and poly(glycolide-co-epsilon-caprolactone) (PGACL) were studied in vitro. These fibers combine a relatively high initial strength and modulus together with sufficient ductility and flexibility, and were therefore chosen for use in stents. The effect of degradation on the tensile mechanical properties and morphology of these fibers was examined. The expandable stents developed from these fibers demonstrated excellent initial radial compression strength. The PLLA stents exhibited excellent in vitro degradation resistance and can therefore support body conduits such as blood vessels for prolonged periods of time. PDS and PGACL stents can afford good support for 5 and 2 weeks, respectively, and can therefore be utilized for short-term applications. The degradation resistance of the stents correlates with the profile of mechanical property deterioration of the corresponding bioresorbable fibers.

Absorbable Implants↗
PubMed1994

Surgical treatment of acromioclavicular dislocation.

Sixty-five patients were operated on for acromioclavicular dislocation between 1980 and 1991. Seventeen type II and 48 type III dislocations according to the criteria of Tossy et al. were treated. Three different surgical techniques were employed. (1) tension band wiring, (2) a modification of the Bosworth repair, (3) reconstruction of the ligaments with augmentation by a PDS (polydioxanon) cord. Forty-four patients could be investigated retrospectively, and an additional 12 were recorded by questionnaire. The Taft score was used, representing self-assessment, clinical statements and radiological findings. Of all investigated patients 87.5% had a normal range of motion without any loss of strength, and 32% suffered an osteoarthritis of the acromioclavicular joint. The average Taft score was 9.8. With respect to the three surgical techniques, reconstruction of the ligaments augmented by a PDS cord produced the best result, an average Taft score of 10.8.

Acromioclavicular Joint↗
PubMed1986

[Intracutaneous skin suture with a resorbable synthetic monofilament suture].

We report about our good experience with a monofile, synthetic, absorbable Polydioxanone thread used for skin suture in an intracutaneous technique, after we performed more than 1,500 sutures of 7 to 30 cm length in patients of any age. We consider the suture to be suitable for children to achieve a cosmetically fine scare without a subsequent necessity to pull out the thread. The breaking strength, the absorbtion rate and the loss of inflammatory reaction is so satisfactory that we could not see any disadvantage by using this absorbable, synthetic thread for skin closure. Especially there was no disturbance in wound healing. In contrast, because of the secure and undisturbed wound-edge adaptation a non-irritant, firm, and hairline-like scar could be achieved. The time to carry out the suture is no longer than for other techniques.

Dermatologic Surgical Procedures↗
PubMed1989

[Experimental studies of stabilization of refixation following median sternotomy].

So far several methods have been established for refixing the sternum halves after longitudinal sternotomy like steel wire or steel strap according to Parham. The use of twisted absorbable PDS-strings is new. During experimental investigations in corpse sterna during tension load the different refixing methods were compared. As a result we found an increased tension stability of the sternum refixation as well as the reversibility of suture dehiscences, if occurred, after employment of the elastic PDS-string. Polydioxanon is a suggestive alternative compared with the usual not absorbable materials for refixation of the sternum.

Biomechanical Phenomena↗
PubMed1984

[Blood vessel wall regeneration in the use of a new monofilament, resorbable suture material for arterial anastomoses].

A new synthetic, absorbable suture has been tested on 15 mongrel dogs. A total of 132 simple end-to-end anastomoses has been performed in common carotid, iliac and femoral arteries and the aorta abdominalis with monofilament, absorbable polydioxanon. Aneurysms or infections did not occur. The patency rate up to 250 days was 98.5%. All vessels were studied by angiography and light- or electron-microscopy. The new monofilament suture material is characterized by extended absorption time and low foreign body reaction. It leads more rapidly to the restitution of the vascular wall than nonabsorbable sutures.

Arteries↗
PubMed1999

Running closure of clean and contaminated abdominal wounds using a synthetic monofilament absorbable looped suture.

The effectiveness of using an absorbable suture material for continuous closure of abdominal wounds, especially contaminated wounds, has not yet been determined. Thus, the present study was conducted to investigate the wound complications that developed following continuous closure of clean and contaminated abdominal wounds using polydioxanone (PDS), compared with those that developed following interrupted closure using braided silk. Running closure using PDS was performed in 152 patients (PDS group), while 280 patients who underwent interrupted closure using braided silk served as controls (SILK group). The occurrence rates of wound dehiscence, early wound infection, and incisional hernia did not differ significantly between the two groups; however, the incidence of late suture sinus formation in the PDS group (1.3%) was significantly lower than that in the SILK group (7.1%). Moreover, late suture sinus formation following PDS suturing healed within 1 week after percutaneous drainage alone without removal of suture strings, whereas late suture sinus following braided silk suturing took an average of 16 days to heal and required removal of the infected suture strings in all 20 patients. These findings indicate the potential usefulness of PDS as a suture material to achieve running closure of clean or contaminated abdominal wounds.

Abdominal Injuries↗
PubMed1990

[The surgical treatment of acromioclavicular joint separation with a resorbable PDS cord].

Osteosynthetic complications in surgery of acromioclavicular separations are common. Also, one more intervention is necessary for removing the metallic implants. Use of self-resorbing materials resolves such disadvantages. One more indirect surgical method is presented. After reposition of dislocated acromioclavicular joint and suture of the disrupted ligaments clavicula is fixed to the coracoid processus by a cord of polydioxanone (= PDS). Early postoperative mobilisation without risks is possible in cooperative patients. Self-resorbing implants don't modify the well known indications of conservative and operative treatment.

Absorption↗
PubMed1998

[Experimental reconstruction of the sheep orbit with biodegradable implants].

In a complex animal model in sheep, polydioxanone (PDS) and polylactic membranes were used for the reconstruction of large orbital-wall defects. In a long-term experiment over 1 year, polylactic implants alone showed the best performance as compared with combinations involving autogenous bone grafts and titanium miniplate fixation. As soon as these polylactic implants are approved for human surgery, they will be used to solve the still challenging problem of anatomical reconstruction of large comminuted fractures of more than one orbital wall.

Animals↗
PubMed1997

[Laparoscopically placed clips on the human cystic duct--an experimental comparison of dislocation between resorbable and titanium clips].

Kryopreserved specimens of cystic ducts were used for displacement tests to investigate the security of different laparoscopic clips. The cystic duct was fixed, and the transverse placed clips were distracted in axial direction and the forces registered. The median values of the six investigated clips ranged between 4.1 N and 11.2 N with a highly significant difference (P < 0.001, Kruskal-Wallis ANOVA). In detail, both resorbable clips (polydioxanone, polyglyconate/polyglycol acetate) were superior to the four titanium clips (P < 0.005, Wilcoxon test). In addition to the advantage of complete biodegradibility, these data favour the use of absorbable clips because holding force is better than that of titanium clips.

Biodegradation, Environmental↗
PubMed1999

[Septum reconstruction with PDS implant].

To achieve septoplasty without compromising the surgical goal of attaining a straight and solid septum, even in cases of marked deviations or severe post-traumatic deformities, we now use a new technique in which the septal reconstruction includes the placement of a resorbable implant as a "compound graft." For this purpose the entire septal cartilage is removed, and the severely deviated part is divided into straight sections that are reconnected to each other to form a straight and solid plate. As connecting material we use a polydioxanon (PDS) foil. The sections of cartilage are sutured to the foil with PDS suture material. The compound graft thus constructed consists of the septal cartilage and resorbable alloplastic material and is reimplanted into the nose. The PDS and suture material are usually resorbed within 8 months, excluding long-term complications. During the past 2 years this method was used in treating 38 patients. The surgical goal was attained in every case, and no immediate or long-term complications occurred. This method of combining septal cartilage with a resorbable implant leads to a better, significant correction of even severe septal deviations.

Adult↗
PubMed1997

[Results of reconstruction of acromioclavicular joint rupture with PDS implants].

From 1986 to 1994, we treated 79 patients with acute acromioclavicular separations by surgical reconstruction. According to the classification of Rockwood and Matsen. 65 patients had type III lesions, 1 patients had a type IV lesion and 13 patients had type V lesions. Both the coracoclavicular ligaments and the ligaments of the acromioclavicular joint were reconstructed. An additional ligamentous augmentation was performed using completely resorbable 5- and 10-mm polydioxanone-sulphate bands. Fifty-five patients (70%) were reexamined 1-7.5 years after surgery (mean 28 months). The results were good to excellent in 50 cases (90%). Fifty-two patients (93%) achieved a range of motion with an abduction deficit of less than 20 degrees. Calcifications in the area of the coracoclavicular ligaments did not affect the final range of motion. Early complications consisted of a subcutaneous infection, one deep infection, and one reconstruction failure. Late complications consisted of a redislocation in 2 patients and symptomatic post-traumatic arthritis of the joint in 3 cases. Augmenting the reconstruction with polydioxyanone-sulphate bands allowed early functional post-operative treatment. With this procedure, patients do not require removal of the implant, and complications from breakage or migration of metal implants are avoided.

Acromioclavicular Joint↗
PubMed1999

Clinical experience with PDS II augmentation for operative treatment of acute proximal ACL ruptures--2-year follow-up.

The results of prospective anterior cruciate ligament (ACL) refixation in 33 patients with high proximal rupture is reported at 20-28 months' follow-up: mean age was 31.1 +/- 12.5 years. The surgical technique was a specially developed refixation of the ACL using a multiple suture loop (modified Marshall technique) augmented with intra-articular PDS II (polydioxanon, resorbable, Ethicon, Hamburg, Germany) to avoid derangement of blood circulation and to guarantee early functional rehabilitation. All patients were operated on within 7.3 +/- 4.5 days after injury. According to the IKDC evaluation score, 22 patients showed excellent and 10 patients good subjective function. Twenty regained their pre-injury level of activity. Anterior stability was tested manually and by KT-1000 max (Medmetric, San Diego). Twenty-eight patients had a firm end-point, although there was a positive Lachman test in 16 patients. Maximal joint laxity as measured by KT-1000 showed a 1-2 mm, 3-5 mm, 6-10 mm and > 10 mm anterior drawer for 16, 14, 2 and 1 patients, respectively. Twenty-five of the evaluated knee joints had a negative pivot shift test. Three patients had a limited range of motion. The potential advantages of PDS II-augmented refixation of acute proximal ACL ruptures are anatomic reconstruction without destruction of other anatomic structures used as grafts, early functional rehabilitation and possibly better proprioception.

Absorbable Implants↗
PubMed2003

Augmentation in anterior cruciate ligament reconstruction-a histological and biomechanical study on goats.

We studied reconstruction of the anterior cruciate ligament (ACL) in skeletally mature goats. In one group, the autogenous tissue was augmented with polydioxanone (PDS), the other group had no augmentation. Histological complete incorporation and remodeling of the transplant was found in both groups. The newly formed connective tissues gradually assumed the microscopic properties of the normal ligament. The augmented group showed a delay in remodeling and maturation of the fiber bundles. Mechanically, the PDS-augmented transplants were stronger than the nonaugmented transplants immediately after surgery. During the first 6 weeks, a rapid decrease in strength of the augmented transplants was found, whereas the strength of the nonaugmented group gradually increased. The results of our experiment do not favor augmentation of autografts in reconstruction of the ACL.

Animals↗
PubMed2005

Evaluation of reconstructed orbital wall fractures: high-resolution MRI using a microscopy surface coil versus 16-slice MSCT.

We evaluated high-resolution magnetic resonance imaging (MR) using a 47-mm microscopy surface coil in comparison to 16-slice multislice CT (MSCT) for postsurgical imaging of reconstructed orbital walls. Twenty-five patients with 27 internal orbital wall fractures were imaged prospectively after reconstruction with resorbable polydioxanone sulfate (PDS) sheets. Coronal high-quality T1- and T2-weighted MR images were obtained with an in-plane resolution of 350 microm within a measure time of 6-7 min for each sequence. Nineteen symptomatic patients underwent MSCT as the current gold standard. In MRI the PDS foil appears in T1- and T2-weighted images as a thin, low-signal-intensity linear structure. In CT it appears hyperdense in comparison to soft tissue and slightly hypodense in comparison to cortical bone. PDS foils could be clearly depicted in 20 out of 25 patients (80%) with MRI and in 13 out of 19 patients (68%) with MSCT. An inadequate foil position or size could be diagnosed in eight patients with MRI and in only three patients with MSCT. In ten symptomatic patients secondary surgery could be avoided because of regular MRI findings except mild hematoma and muscle edema. High-resolution MRI of the orbit using a 47-mm microscopy coil is a promising method to accurately demonstrate normal and pathologic conditions in symptomatic patients after orbital wall reconstruction with PDS foils.

Adolescent↗
PubMed1996

Absorbable clips for cystic duct ligation in laparoscopic cholecystectomy.

BACKGROUND: The efficacy and applicability of an absorbable polydioxanone (PDS) clip for cystic duct ligation were evaluated in 297 patients undergoing laparoscopic cholecystectomy. METHODS: The indications for cholecystectomy were symptomatic gallstones (179 patients), acute cholecystitis (67), biliary pancreatitis (23), acute cholangitis (24), and gallbladder polyp (4). RESULTS: Twenty-five patients required conversion to open surgery (8.4%). The conversion rate was 2.7% for uncomplicated and 17.5% for complicated gallbladder diseases. Of the 272 patients with laparoscopic cholecystectomy, the cystic ducts were successfully ligated with PDS clips in 227 patients (83.5%). The success rate was higher in uncomplicated (163/178) than in complicated (64/94) gallbladder diseases (chi square = 24.6, P < 0.001). There was no clip-related complication on follow-up (range 0.4-39.2, median 17.5 months). In 45 patients, PDS clip failed. They were treated with endoloop (14 patients), Roeder slip knot (13), metallic clips and endoloop (8), metallic clips alone (6), and intracorporeal tie (4). CONCLUSIONS: The PDS clip is effective and applicable to the majority of patients. It should be attempted first because of the ease of application.

Absorption↗
PubMed1991

Growth of tracheal anastomoses: advantage of absorbable interrupted sutures.

Growth of the trachea after complete transection and anastomosis was studied in four groups of 1-month-old New Zealand white rabbits. The trachea was transected at the fifth cartilaginous ring and then anastomosed with continuous 6-0 polypropylene (Prolene) (group 1), interrupted 6-0 polypropylene (group 2), continuous 6-0 polydioxanone (PDS) (group 3), or interrupted 6-0 PDS (group 4). The animals were followed up for 90 to 103 days (mean follow-up, 95 days). At the time the animals were killed, body weight had increased 125% (1.2 to 2.7 +/- 0.18 kg). Growth of the trachea was assessed at the time of death. Results from this study suggest that growth of a tracheal anastomosis is retarded in a growing animal model. The degree of resultant stenosis was significantly less when an absorbable suture material (PDS) and an interrupted suturing technique were used.

Anastomosis, Surgical↗
PubMed1992

Chest wall stabilization with synthetic reabsorbable material.

Experimental results and preliminary clinical experience with synthetic reabsorbable materials in chest wall reconstruction are reported. Six beagle dogs underwent chest wall resection involving three or four consecutive ribs. Reparative procedure was performed by construction of a polydioxanone-band grid, anchored to the adjacent undamaged ribs. A mild wound infection developed in 1 animal but resolved without rejection of the prosthesis. The experimental material has shown favorable properties, both mechanical and biological. Subsequently, 11 patients, with different indications, underwent reconstructive procedures of the chest wall with reabsorbable prostheses. No complications have occurred. Long-term stability was excellent in all patients, with a mean follow-up longer than 6 months. The advantages of reabsorbable compounds are pointed out along with the possible applications for chest wall reconstruction after chest wall resection.

Absorption↗
PubMed1990

Stress relaxation of organic suture materials.

Sutures fabricated from synthetic polymeric materials exhibit the phenomenon of stress relaxation, that is, when held under tension at a fixed elongation, there is a gradual realignment of the microstructure to accommodate the developed tensile stress. This property has been characterized for three modern suture materials, polypropylene, polydioxanone and poly(glycolic acid). All three materials exhibited stress relaxation but to different degrees, with polypropylene exhibiting the greatest stress relaxation (to approximately 40% of the initial load). The initial rate of stress relaxation increased with the rate of loading but the residual stress level was found to be independent of elongation rate except at extremely low rates of loading.

Biocompatible Materials↗