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PubMed1984

Clinical and experimental studies with a resorbable transosseous ligature.

Transosseous wire ligatures are used to oppose bone fragments during healing. Thereafter, such ligatures serve no function, and either remain permanently in the tissues or are removed by a second surgical procedure. This paper reports clinical and experimental studies with polydioxanone (PDS--Ethicon Ltd.), on the basis of which it is introduced as an alternative to stainless steel wire in some cases of transosseous fixation.

Absorption↗
PubMed1992

The effect of inflammatory synovial fluid on the breaking strength of new "long lasting" absorbable sutures.

The effect of inflammatory synovial fluid upon several absorbable sutures potentially useful for arthroscopic procedures, e.g., meniscus repair and shoulder stabilization, was studied by implanting lengths of these sutures into unstable, arthritic rabbit knees and testing their breaking strength after varying time periods (up to 18 weeks). Polyglyconate (Maxon) sutures retained no significant strength at 6 weeks. Polydioxanone (PDS) sutures began to lose breaking strength at 3 weeks, retained only 40% of their original strength 6 weeks after implantation, and had no measurable strength at 9 weeks. Polycaprolactone (LTS) sutures showed a slow reduction in strength and retained approximately 90% of their original breaking strength after 18 weeks of implantation. Green braided polyester (Mersiline) sutures showed no loss of breaking strength over the testing period. Measurements of inherent viscosity were made to give an indirect indication of the decline in molecular weight of these sutures. These data paralleled the breaking strength decline in every case. The surgeon selecting an absorbable suture must consider the length of time the suture will hold the target tissue. This information should be helpful to surgeons considering an absorbable suture for procedures such as meniscus repair and shoulder stabilization.

Absorption↗
PubMed1990

Sternal fixation with resorbable suture material.

The applicability of absorbable sutures for sternal closure was investigated. Heavy braided Polydioxanon (PDS Ethicon) sutures were tested in a routine fashion, as were steel wire and braided polyester. In a pilot study, 2 patients (20%) had a complete sternal dehiscence. These results forced us to abandon the project.

Bone Wires↗
PubMed2006

Meniscal repair for anterior horn tear of the lateral meniscus.

This technical note describes all-inside meniscal repair for anterior horn tears of the lateral meniscus. A modified anteromedial portal is created for use in visualizing the anterior horn of the lateral meniscus. A crescent-shaped suture hook loaded with a polydioxanone suture (PDS) is inserted through an anterolateral portal. The hook tip penetrates the meniscal peripheral rim and advances across the tear. The suture hook penetrates the mobile central fragment. A leading limb of the PDS is advanced into the knee joint. Then, the leading limb of the suture is retrieved back to the anterolateral portal. With 2 limbs of PDS, endoscopic knot tying is done. With this simple technique, vertically oriented all-inside meniscal repair of an anterior horn tear of the lateral meniscus with the use of absorbable suture materials is easily performed.

Absorbable Implants↗
PubMed2004

Sternal closure with reabsorbable pin and cord in pediatric-less invasive cardiac surgery.

In pediatric less invasive cardiac surgery, we recently closed a patient's sternum using reabsorbable radiolucent poly-(L-lactide) acid sternal pins together with multifilament polydioxanone cord after a lower partial median sternotomy. This combination completely prevents postoperative sternal deformity, and leaves no radiopaque material identifiable radiographically, which is a significant cosmetic benefit.

Bone Nails↗
PubMed1999

Examination of the safety and efficacy of an absorbable dura mater substitute (Dura Patch) in normal applications in neurosurgery.

BACKGROUND: The possibility of the transmission of Creutzfeldt-Jakob disease and slow virus infection (HIV) by cadaveric dura implants makes it necessary to find synthetic, absorbable substitute materials for plastic reconstruction of the dura mater. Dura-Patch is a bilayered composite of a dyed polydioxanone (PDS) foil and an undyed fleece of Polyglactin 910 (Vicryl) and PDS threads, known to be completely resorbable. METHODS: The Dura-Patch was tested prospectively in 101 patients undergoing 75 supratentorial, 20 infratentorial, and 6 spinal operations in seven different neurosurgical departments. Fixation of the substitute was either by suturing, gluing, or both. The specific tissue properties were investigated considering biocompatibility, form, size, adaptability, fixation, scarring, and resistance to CSF tearing with the aid of hematologic and neurological parameters, CCT, and/or MRI scanning up to 6 months postoperatively. RESULTS: A total of 76 of 101 patients completed the study (75%). The biocompatibility of the Dura-Patch with timely absorption of the implant material was excellent without exception. There was no notable local scarring and no infections. Transient CSF cushioning in 12.9% of the patients was in keeping with the normal range. The elasticity and flexibility of the Dura-Patch was rated as "good" in 90% and was still better when the size of the implant increased, with an overall rating of handling as "good" or "excellent" in 97% of all operations. CONCLUSIONS: The new absorbable Dura-Patch showed itself to be suitable for both plastic dura reconstruction and plastic extension of the subdural space with primary, watertight, germproof closure in routine intracranial and spinal tumor removal.

Brain Diseases↗
PubMed2001

Augmentation of a ruptured posterior cruciate ligament provides normal knee joint stability during ligament healing.

OBJECTIVE: To identify an augmentation technique which would provide mechanical protection for the healing posterior cruciate ligament. DESIGN: Six human knee specimens were tested in vitro for posterior knee joint stability after augmenting the cut posterior cruciate ligament by six different techniques using a resorbable double strand Polydioxanone augmentation device. BACKGROUND: A fresh isolated rupture of the posterior cruciate ligament is often treated conservatively. Results have shown that it can heal, but ligament elongations occur frequently. Therefore a method is needed to provide posterior knee joint stability during ligament healing. METHODS: The effect of different femoral augmentation insertions on posterior knee stability was tested by recording the antero-posterior (AP) position of the tibia and the augmentation force. Testing was performed during flexion--extension cycles and under posterior shear loads. RESULTS: The insertion combination that proved to stabilize the joints best consisted of one augmentation strand leading along the antero-lateral posterior cruciate ligament fibres and inserting at the distal end of the Blumensaat line and one strand leading along the posteriormedial fibres and inserting in the middle of the Blumensaat line. AP translations similar to those occurring in healthy knee joints could be achieved. CONCLUSIONS: It is possible to restore normal posterior knee joint stability by implanting a double strand augmentation device. This can help a posterior cruciate ligament to heal under non-elongated conditions.

Absorbable Implants↗
PubMed1999

A new strategy for the surgical treatment of aortic coarctation associated with ventricular septal defect in infants using an absorbable pulmonary artery band.

OBJECTIVES: We propose a new strategy using coarctation repair together with a polidioxanone absorbable pulmonary artery banding to limit operative risk and to spare infants with aortic coarctation subsequent operations. BACKGROUND: The alternative for the surgical management of aortic coarctation associated with ventricular septal defect (VSD) is single-stage repair versus coarctation repair with or without banding of the pulmonary artery. METHODS: Eleven infants (mean weight 2,560 +/- 1,750 g, range 1,320 to 3,800 g) underwent a coarctation repair with a polydioxanone banding. Seven had a trabecular and four a perimembranous VSD. The mean size of the VSD was 5 +/- 0.7 mm (range 4 to 7 mm). The systolic pulmonary pressure was >80% of the aortic pressure in all. The pulmonary band was tightened until the systolic pulmonary pressure fell below 50% of the aortic pressure. RESULTS: There were no hospital deaths. The reabsorption of the banding was complete after 5.7 months in all patients (3 to 6.5 months). The VSD closed completely in four infants and partially in six, in whom the pulmonary artery pressure was normal without evidence for significant left-to-right shunt. One patient with a large trabecular VSD underwent surgical closure of his defect after four months. Finally, a subsequent open-heart surgery could be avoided in 91% (10/11) of patients. CONCLUSIONS: Provided the VSD belongs to types prone to close spontaneously, this policy may reduce the number of surgical procedures per infant as well as in-hospital mortality and morbidity rates. It should be proposed as an alternative to more complex procedures.

Absorbable Implants↗
PubMed2000

Knot security in simple sliding knots and its relationship to rotator cuff repair: how secure must the knot be?

We sought to determine which simple sliding knot configurations would have adequate strength for rotator cuff repair. Four knot configurations were tied with both No. 1 polydioxanone suture and No. 2 Ethibond suture (Ethicon, Somerville, NJ) using 3 different tying techniques: hand-tie, standard knot pusher, and cannulated double-diameter knot pusher. The knots were then tested to failure on a materials testing system. The weakest standard knot configuration was S=S=S=S. The other 3 knot configurations (S//S//S//S, SxSxSxS, and S//xS//xS//xS) generally failed in the 35 to 50 N range. Ultimate strength in this range can be shown to be adequate to withstand, without suture failure, a maximal contraction of a repaired rotator cuff tear within the rotator crescent, assuming certain conditions are met (suture anchors placed 1 cm apart, 2 sutures per anchor). More complex knots are not necessary for adequate knot security. However, the same configuration with only 1 suture per anchor will not be strong enough because the suture will fail under maximum physiological load. This study shows that we can predict the adequacy of a given knot configuration under maximum physiological loading conditions.

Arthroscopy↗
PubMed1999

Scanning electron microscopy study including maceration techniques of an absorbable alloplastic implant designed for the reconstruction of ventral abdominal wall defects.

The interposition of synthetic material represents the most generally acknowledged method for achieving a tension-free surgical repair of major abdominal wall defects. As permanent materials are frequently associated with severe complications (rejection, peritonitis, enterocutaneous fistula, erosive invasion into the intestine), a newly designed absorbable prosthetic (polydioxanone, PDS) has been developed. The ellipsoid implant is composed of a knitted envelope and a filling of loosely arranged filaments. Interpositioning of the implant into an artificial circular abdominal wall defect was carried out on 30 Wistar rats. Explantation was performed 21 days post implantationem (p.i.), 42 days p.i. and 180 days p.i. The aim of the study was to evaluate the use of scanning electron microscopy (SEM) combined with maceration techniques (2 N NaOH for 1, 3 and 5 days) for a spatial assessment of the interactions between the implanted material and the ingrowing tissue components. Application of 2 N NaOH caused the complete dissolution of the PDS-material and a concomitant gradual disappearance of cellular and amorphous tissue components, thereby unmasking the remaining collageneous network. SEM of non-macerated specimens demonstrated that 21 days p.i. the entire implant has been filled with connective tissue components. Additionally, the ventral and dorsal surfaces of the implant were covered by a collageneous layer (neo-fascia). 21 days p.i. the PDS-filaments had developed minor clefts, which increased in number and depth 42 days p.i., and were transformed into small remnants 180 days p.i. Alkali treatment revealed the three-dimensional arrangement of collagen fibers, which ensheathed the PDS-filaments and formed interconnecting networks between them. At the ventral portion of the implant the fibrous network was more elaborate and densely distributed. 180 days p.i. the implant has been transformed into a membranous structure (neo-membrane) composed of the ventral and dorsal neofascia, remnants of PDS-filaments and a continuous connective tissue layer containing wave-like collagenous structures. Whereas 21 and 42 days p.i. no herniation was observed, 130 days p.i. the implant began to bulge out of the ventral abdominal wall. It is therefore concluded that inspite of the advantages of absorbable materials, longer resorption times may be required to allow a sufficient consolidation of the ingrowing connective tissue to resist the tensile forces of the abdominal muscle coat. SEM combined with 2N NaOH maceration proved to be a usefull tool in addition to conventional histological techniques for a three-dimensional assessment of fibrous connective tissue components ingrowing into alloplastic implants.

Abdominal Muscles↗
PubMed1995

Laparoscopic repair of bladder injury and laceration.

The management of bladder injuries at laparoscopy is controversial. Some endoscopists believe in mandatory open repair, whereas others recommend laparoscopic cystotomy repair. We performed laparoscopy to treat two women with bladder injury, one with excision of a transmural nodule of bladder endometriosis, and the other with incidental cystotomy during adenexectomy in the presence of obliterative adhesions. After localizing the injury to the dome of the bladder remote from ureters, the edges of the injury were cleaned of damaged tissue and apposed in two layers using interrupted 4-0 polydioxanone endocorporeal sutures. The patients had an uneventful postoperative course, and neither experienced bladder function problems. We conclude that applying the already established tenets of bladder injury repair by laparotomy to laparoscopic procedures is acceptable in most endoscopic settings.

Adnexal Diseases↗
PubMed1988

A prospective randomized trial of suture material in aural wound closure.

The aim of the study was to compare synthetic monofilament suture materials with chromic catgut and silk in aural wound closure. Forty patients undergoing mastoidectomy or tympanoplasty were randomized to closure with either 3o PDS (Polydioxanone) to fascia plus 3o Prolene to skin, or 2o chromic catgut to fascia plus 3o silk to skin. Known or suspected factors affecting wound healing were recorded. Nine patients had post-operative wound infections. The infection rate was significantly lower in wounds closed with PDS and Prolene (chi 2 = 6.05, p less than .05), and in tympanoplasty operations (chi 2 = 4.42, p less than .05). Four patients suffered wound dehiscence, all four had been closed with catgut and silk. No other complication of wound healing was noted in the trial. In conclusion, PDS and Prolene are superior suture materials to catgut and silk in the closure of aural wounds.

Adult↗
PubMedDate not supplied

Use of a simple suture to stabilize the chevron osteotomy: a prospective study.

A clinical and radiographic review was undertaken in 27 patients (30 feet) who underwent a chevron osteotomy stabilized with a double loop of polydioxanone suture. The mean patient age at the time of surgery was 40 years (range, 16 to 66 years). At 6 weeks postoperatively, all patients showed clinical and radiographic union at the osteotomy site. In 1 foot, the initial correction was lost with radiographic evidence of an angulated distal fragment with no medial translation. There were no cases of wound infection, sinus formation, or avascular necrosis of the metatarsal head. No patients required further surgery. This method of stabilizing a chevron osteotomy is technically straight forward, with a predictable outcome, and provides a valid low cost alternative to screw, bioabsorbable implant, or Kirschner wire.

Adolescent↗
PubMed2000

[Osteosynthesis with resorbable hemi-cerclage in metacarpal fractures].

The use and results of biodegradable hemicerclages for metacarpal fracture fixation were reviewed retrospectively. A total of 92 metacarpal fractures in 78 patients were treated with polyglycolic or polydioxanon sutures. Study parameters included time for bony union, duration of immobilisation, total active range of motion, and complications. The hemicerclage achieved rigid fracture fixation and permitted early mobilisation exercises without jeopardizing bony union. Immobilization of metacarpals was performed for a median of 3.4 (1.5 to 6) weeks. There were no complications of wound healing. Adequate bony union was achieved after a median of 4.5 weeks (3.5 to 7 weeks). In one case, premature loading of the fracture led to displacement and delayed union. At the end of treatment (6.1 [4 to 7.5] weeks), total active range of motion was 98 (85 to 100)%. Ideal indications are oblique or torsion fractures of the metacarpals. In these cases, immobilisation up to wound healing is sufficient.

Adolescent↗
PubMed2003

Urothelial mesh--a new technique of cell culture on biomaterials.

INTRODUCTION: Urogenital malformations, trauma or tumours may demand surgical reconstruction in children. Cell culture is an important technology in biomaterial research and tissue engineering. Tissue-engineering of urothelial organs is of interest in children, because the number of complications and re-operations may be reduced. Actually, monolayer cultures of urothelium are used for tissue engineering and biocompatibility testing. A culture system that more closely mimics the physiologic environment of the urothelium would be of interest. The aim of this study was to determine the biological and mechanical characteristics of urothelial mesh cultured in vitro. METHODS: Meshes containing urothelium, lamina propria, and submucosal tissue were generated using a skin mesh graft cutter. Meshes were cultured in 6-well plates, on collagen I/III, polydioxanone/polylactic acid and silicone matrices. Cell morphology was examined by inversion microscopy, histology, and scanning electron microscopy. It was compared to urothelium cultured by methods reported in the literature. To define the basic mechanical properties, meshes were extended longitudinally by a servohydraulic testing machine and strain diagrams generated. RESULTS: Urothelium was reproducibly cultured from meshes. Cell growth could be induced onto fibrillary collagen, polydioxanone-polylactic acid matrices and shaped polyurethane surfaces. Cells formed confluent layers of flat cells, resembling native urothelium. The meshes have unique mechanical properties, allowing for stable fixation, surgical handling and mechanical stimulation. CONCLUSIONS: Meshes can be used for cell culture on biomaterials. They maintain epithelial-stromal integrity and mechanic stability. The small size of tissue bridges allows in vitro culture for long periods with many potential advantages for tissue engineering and biologic research. Applications are possible both in vitro and in vivo.

Biocompatible Materials↗
PubMed2006

Reconstructive septal surgery.

To attain without compromise the surgical goal, a straight and concurrently solid septum, especially in cases of marked deviations or severe post-traumatic deformities (sometimes combined with external deformities), an excellent proven and well-known technique is extracorporal or external septoplasty. Surgery consists of excision of the quadrilateral cartilage and its division into straight fragments. To avoid postoperative sequelae such as saddling, the pieces of cartilage must be reconnected meticulously to form a straight and at the same time solid plate. This difficult and time-consuming procedure can be assisted by the use of a connecting material. Since 1996 we have been using a polydioxanone foil (PDS, Ethicon Norderstedt Germany) as the supporting material for this purpose. The PDS as well as the suture material is completely resorbed within 5 months, excluding long-term complications of other artificial implants.

Absorbable Implants↗
PubMed1996

A method to reduce tension at the suture site.

Moderate-sized defects following injuries of peripheral nerves, like the median or ulnar, can be bridged instead of undergoing secondary repair with grafting, by primary or early secondary suturing using polydioxanon microbands (20 mm in length, 1 mm in width). Attached to the epineurium on both sides of the suture site, the bands help to reduce tension, thus reinforcing tensile strength. Early mobilization is possible. Primary or early secondary suturing is favored also in cases with defects up to 25 or even 30 mm, if the elasticity of the stumps permits sufficient elongation without hazard to the blood supply. Gaps of more than 30 mm require nerve grafting.

Adolescent↗
PubMed1990

A comparative study of the use of 9-0 PDS and 9-0 prolene in microvascular anastomosis.

9-0 absorbable polydioxanone (PDS) has been compared to 9-0 nonabsorbable Prolene in order to evaluate any advantages of either suture in microvascular surgery. In each of 29 rats, one carotid artery was anastomosed end-to-end with PDS and the other with Prolene. Specimens were harvested 48 hr, 14 days, and three, and five months postoperatively. Histologic examination of the carotids followed postmortem using 4.5 x magnification angiography. Histologic analysis of inflammation, fibrosis, and medical necrosis of the anastomoses revealed no significant differences between the two materials. There was no difference as regards stenosis and aneurysm formation, when evaluated independently by the two methods. It was observed that saccular aneurysms formed as a result of medial necrosis and could develop at any time. Fusiform aneurysms formed where the media was replaced by bulging fibrosis and they appeared late. External support of adherent skeletal muscle prevented aneurysm formation. It can be concluded that the amount of inflammation and fibrosis leading to stenosis is related to the amount of trauma at the time of surgery and not to the type of suturing material used.

Anastomosis, Surgical↗