Feasibility study of sutureless distal coronary anastomoses with degradable Y-shunt and tissue adhesives in a porcine off-pump model.

Interact Cardiovasc Thorac Surg. 2006 Dec;5(6):676-9

Authors: Wippermann J, Konstas C, Wahlers T, Albes JM

The purpose of this study was to examine the feasibility of the combined use of intraluminal biodegradable shunts and surgical adhesives for sutureless distal coronary anastomosis. Eighteen LITA-LAD anastomoses were created in a porcine beating heart model. In group I (n=9) a custom-made silicone Y-shunt provided internal stability, while three different adhesives, N-butyl-2-cyanoacrylate-glue (CYAC); albumin-glutaraldehyde-glue (AG); fibrin-glue (FIB), were applied externally. In group II (n=9) biodegradable polydioxanone (PDS) shunts were used. All anastomoses were examined intraoperatively by flow measurement, blood leakage was quantified and physical strength was tested. In all pigs anastomoses could be created successfully at first attempt, but anastomotic leaks requiring additional sutures occurred in 6 animals. LITA-flow significantly decreased in both groups. A patency rate of 89.9% (8/9) was found in group I while it was 66.6% (5/9) in group II. The lowest amount of blood-loss was measured when CYAC adhesive was used while tensile strength was lowest in the FIB-anastomoses. Preliminarily we could demonstrate the feasibility of performing sutureless distal coronary anastomosis by means of a combination of adhesives and temporary intraluminal shunts. PDS-shunts, however, resulted in a high graft-occlusion rate, so that potentially less thrombotic materials need to be investigated.

PMID: 17670681 [PubMed]

Use of spider silk fibres as an innovative material in a biocompatible artificial nerve conduit.

J Cell Mol Med. 2006 Jul-Sep;10(3):770-7

Authors: Allmeling C, Jokuszies A, Reimers K, Kall S, Vogt PM

Defects of peripheral nerves still represent a challenge for surgical nerve reconstruction. Recent studies concentrated on replacement by artificial nerve conduits from different synthetic or biological materials. In our study, we describe for the first time the use of spider silk fibres as a new material in nerve tissue engineering. Schwann cells (SC) were cultivated on spider silk fibres. Cells adhered quickly on the fibres compared to polydioxanone monofilaments (PDS). SC survival and proliferation was normal in Live/Dead assays. The silk fibres were ensheathed completely with cells. We developed composite nerve grafts of acellularized veins, spider silk fibres and SC diluted in matrigel. These artificial nerve grafts could be cultivated in vitro for one week. Histological analysis showed that the cells were vital and formed distinct columns along the silk fibres. In conclusion, our results show that artificial nerve grafts can be constructed successfully from spider silk, acellularized veins and SC mixed with matrigel.

PMID: 16989736 [PubMed - indexed for MEDLINE]

[Tendon holding capacities of the suture materials used in repairing Achilles tendon rupture]

Acta Orthop Traumatol Turc. 2006;40(2):164-8

Authors: Yildirim Y, Saygi B, Kara H, Cabukoğlu C, Esemenli T

OBJECTIVES: We evaluated tendon holding capacities of suture materials that are commonly used in repair of Achilles tendon ruptures. METHODS: Achilles tendons of 60 sheep were removed by incisions 2-cm proximal to the calcaneal insertion and 1-cm distal to the musculotendinous junction. The tendons were randomly divided into six groups and sutures were placed with the Kessler technique at the distal end of the tendons using one of the following suture materials: 2 polydioxanone (PDS), 1 PDS, 2 Vicryl, 1 Vicryl, 2 Ethibond, and 1 Prolene. The distal end of the suture material was left free. Each specimen was mounted in an Instron machine, with the tendon being placed proximally and the suture material distally. The system was loaded with a displacement rate of 20 mm/min. RESULTS: Failure of all the specimens was due to pull-out of the suture material through the tendon. There were no failures due to suture breakage. The highest and the lowest tendon holding capacities were found with 2 PDS and 2 Ethibond sutures, respectively. CONCLUSION: Following Achilles tendon repair, the healing period, in particular the first three weeks, is precarious for pull-out of the suture material through the tendon. Thus, tendon holding capacity of the suture material is an important factor for the strength of the repair. Among the tested suture materials, 2 PDS was found to have the highest tendon holding capacity.

PMID: 16757935 [PubMed - indexed for MEDLINE]

[Randomized clinical study of polydioxanone and nylon sutures for laparotomy clousure in high-risk patients]

Cir Esp. 2006 May;79(5):305-9

Authors: Docobo-Durantez F, Sacristán-Pérez C, Flor-Civera B, Lledó-Matoses S, Kreisler E, Biondo S

INTRODUCTION: The complications of surgical wound closure in patients with risk factors significantly increases morbidity and mortality. The aim of the present study was to evaluate differences in abdominal wall closure in patients with risk factors with the same closure technique and slow-absorbable or non-absorbable sutures. MATERIAL AND METHODS: We performed a prospective, multicenter, comparative study of polydioxanone versus nylon sutures. Laparotomies performed for intestinal diseases and hepatobiliopancreatic procedures in patients with at least one risk factor were included. Exclusions criteria were eventrations, interventions for obesity, the need for reinforcement sutures, uncommon incisions, life expectancy of less than 1.5 years and deaths unrelated to the wound. Closure was performed with monoplane, extracutaneous, continuous, en bloc, loop sutures. Infection, evisceration, dehiscence, extrusion, sinus, eventration, intolerance, and pain were evaluated. Postoperative follow-up was performed at 10 and 30 days, 3 and 6 months, and at 1 and 1.5 years. RESULTS: A total of 770 patients were included (451 in the polydioxanone group and 319 in the nylon group). A total of 78.05% were midline incisions, with a mean length of 23.3 cm. Caliber 1 sutures were most frequently used (85.45%), and 1.7 sutures were used per patient. No complications occurred in 94.03% with no differences between groups (94.7% polydioxanone and 93.1% nylon). The results were similar throughout follow-up. The surgical infection rate was 10%. No differences were found in any of the follow-up assessments in any of the variables analyzed. CONCLUSIONS: Abdominal wall closure should be performed with continuous slow-absorption sutures such as polydioxanone since this type of suture has a similar complication rate to reabsorbable sutures and presents greater biocompatibility.

PMID: 16753121 [PubMed - indexed for MEDLINE]

Ventral laparoscopic abomasopexy on adult cows.

Can Vet J. 2006 Apr;47(4):343-8

Authors: Babkine M, Desrochers A, Bouré L, Hélie P

Displacement of the abomasum is frequently diagnosed by veterinarians in bovine practice and numerous surgical techniques have been developed to treat and prevent this condition. Complications secondary to those techniques are related to their degree of invasiveness and the development of postoperative wound infections. The objectives of this study were to describe a safe and reliable abomasopexy technique by laparoscopy and to assess postoperative adhesion formation. A ventral laparoscopic abomasopexy was performed on 10 adult dry cows. The abomasum was fixed with 4 simple interrupted sutures using USP 2 polydioxanone suture material. No major complications were encountered during the surgery. Abomasal adhesions were visually evaluated by laparoscopy 3 mo postoperatively. This technique proved to be simple and safe, and it provided adequate abomasum fixation in healthy dry cows. It could be used to surgically correct left displaced abomasum.

PMID: 16642872 [PubMed - indexed for MEDLINE]

[Polypropylene and polydioxanone show similar biomechanical efficacy in midline closure]

Cir Esp. 2005 Dec;78(6):377-81

Authors: Bellón JM, Rodríguez M, Serrano N, García-Honduvilla N, Gómez V, Buján J

INTRODUCTION: After laparotomy, the incidence of incisional hernia is high, especially when the abdomen in opened along the linea alba, a weak structure of the abdominal wall. This study was designed to evaluate the biomechanical resistance of midline closure using the same surgical technique but two different types of suture material, a long-lasting absorbable material and a non-absorbable material. MATERIAL AND METHODS: A 7.5 cm midline laparotomy was performed in 48 New Zealand White rabbits. The surgical wound was then repaired with an en masse running suture using polypropylene 4/0 or polydioxanone 4/0. Animals not subjected to surgery were used as controls. Morphological, immunohistochemical and biomechanical tests were undertaken 3 weeks, 6 weeks and 6 months after surgery. RESULTS: Both types of suture gave rise to scar tissue composed of collagen fibers concentrically arranged around the suture filaments. Six months after surgery, the polydioxanone suture had almost completely degraded. The macrophage response steadily diminished over time, although it was significantly greater in wounds closed by polydioxanone suture. No significant differences were found in the biomechanical strength provided by the two types of suture. CONCLUSIONS: After laparotomy closure at the linea alba, both suture materials showed optimal biological behavior. The composition of the suture material did not affect the tensile strength of the repair zone.

PMID: 16420865 [PubMed - indexed for MEDLINE]

An in vivo microfabricated scaffold for tendon repair.

Eur Cell Mater. 2005;9:50-7; discussion 57

Authors: Curtis AS, Wilkinson CD, Crossan J, Broadley C, Darmani H, Johal KK, Jorgensen H, Monaghan W

A new type of in vivo tissue engineering system for tendon repair in situ after cut or crush of a flexor tendon is described. The system is based on the topographical reaction, alignment, migration and perhaps proliferation of tendon cells on micrometrically grooved substrates made in a biodegradable polymer. Macrophage trapping in the structure may also help to prevent inflammation. Tendon damage including crush and section injury is a fairly frequent occurrence. The conventional treatment is surgical repair, however frequently this leads, especially in hand wounds, to attachment of the tendon surface to the surrounding synovium, which is very undesirable. We present an approach based on using a biodegradable device to ensure that the healing of severed or crushed flexor tendons is aided, synovial adhesion prevented and the final result anatomically correct. The biodegradable sheath carries microgrooves fabricated into the polymer by embossing that orient and guide the cells towards each other from either side of the region of damage. After six weeks an apparently normal functional tendon is reformed.

PMID: 15887094 [PubMed - indexed for MEDLINE]

Safety of donor right hepatectomy without abdominal drainage: a prospective evaluation in 100 consecutive liver donors.

Liver Transpl. 2005 Mar;11(3):314-9

Authors: Liu CL, Fan ST, Lo CM, Chan SC, Yong BH, Wong J

Although the role of routine abdominal drainage after liver resection for tumors has been questioned, abdominal drainage after donor right hepatectomy for live donor liver transplantation (LDLT) has been a routine practice in most transplant centers. The present study aimed to evaluate the safety of the procedure without abdominal drainage. A prospective study was performed on 100 consecutive liver donors who underwent right hepatectomy for LDLT from July 2000 to September 2003. Biliary anatomy was carefully studied with intraoperative cholangiography using fluoroscopy. The middle hepatic vein was included in the graft in all except 1 patient. Parenchymal transection was performed using an ultrasonic dissector. The right hepatic duct was transected at the hilum and the stump was closed with 6-O polydioxanone continuous suture. Absence of bile leakage was confirmed with methylene blue solution instilled through the cystic duct stump. The abdomen was closed after careful hemostasis without drainage in all donors. The median age of the donors was 36 years (range 18-56 years). Median operative blood loss and operating time were 350 mL (range 42-1,400 mL) and 7.5 hours (range 5.2-10.7 hours), respectively. None of the donors required any blood or blood product transfusion. There was no operative mortality. The median postoperative hospital stay was 8 days (range 5-30 days). Postoperative morbidity occurred in 19 patients (19%), most of which were minor complications. No donor experienced bile leakage, intraabdominal bleeding, or collection. None required surgical, radiologic, or endoscopic intervention for postoperative complications, except for 1 donor who developed late biliary stricture that required endoscopic dilatation. All donors were well with a median follow-up of 32 months (range 11-50 months). In conclusion, with detailed study of the biliary anatomy and meticulous surgical technique, donor right hepatectomy can be safely performed without abdominal drainage. Abdominal drainage is not a mandatory procedure after donor hepatectomy in LDLT.

PMID: 15719390 [PubMed - indexed for MEDLINE]

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

Arch Facial Plast Surg. 2003 Jul-Aug;5(4):316-9

Authors: Boenisch M, Tamás H, Nolst Trenité GJ

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.

PMID: 12873869 [PubMed - indexed for MEDLINE]

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

Fed Regist. 2002 Dec 19;67(244):77675-7

Authors:

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.

PMID: 12492104 [PubMed - indexed for MEDLINE]

Repair of flexor tendon defects of rabbit with tissue engineering method.

Chin J Traumatol. 2002 Aug;5(4):200-8

Authors: He Q, Li Q, Chen B, Wang Z

OBJECTIVE: To repair rabbit tendon defects with tissue engineering method. METHODS: The third passage of fetal skin fibroblast cells was labeled with 5-bromo-2' deoxyuridine (Brdu) and then seeded on human amnion extracellular matrix (HA-ECM). Using 1 cm-long-Achilles tendon defects as repairing models in the experimental group, tendon defects were core bridged with polydioxanone (PDS) and then capsulated with the complex of fibroblasts-HA-ECM. In the control group I, defective tendons were sutured with PDS following the former procedure and capsulated with HA-ECM (without fibroblasts). In the control group II, only PDS was applied to connect the defective tendons. Gross examination, light microscopy, scanning electronmicroscopy and biomechanical measurement of the repaired tendons were respectively performed at postoperative 1, 2, 3 month as well as immunohistochemical examination. RESULTS: The optimal cell concentration for seeding fibroblasts was 3.5 x 10(6) cells/ml. Cells grew well and radiated or paralleled on HA-ECM. Immunohistochemistry showed that the labeled seed fibroblasts played an important role in tendonization. The results of light microscopy, electron microscopy, and biomechanical assessment suggested that the rate and quality of tendonization in the experimental group was superior to those of the control group I and II. The tensile strength in the experimental group was the greatest, the next was in the control group I, and the worst in the control group II (P<0.05). CONCLUSIONS: HA-ECM is the excellent carrier for fibroblasts. Fibroblasts-HA-ECM complex has the capability to repair tendon defect and to tendonize with rapid rate and good performance three months after operation. Its tensile strength is 81.8% of that of normal tendon.

PMID: 12162896 [PubMed - indexed for MEDLINE]

Saphenous vein harvesting by 'stripping' technique and 'W'-shaped patch covering after plaque incision in treatment of Peyronie's disease.

Int J Impot Res. 2000 Dec;12(6):299-301

Authors: De Stefani S, Savoca G, Ciampalini S, Gattuccio I, Scieri F, Belgrano E

Harvesting of the saphenous vein tract by means of leg stripping is proposed in the treatment of Peyronie's disease. The technique of W-shaped saphenous vein after plaque incision to correct severe penile deformity associated with Peyronie's disease is described. Graft material was obtained from the lower saphenous vein by means of distal 'leg short stripping' technique. The size and number of tunical incisions depended on the size of the plaque. A 15 cm venous segment is generally sufficient to cover the defect. The venous segment used was W-shaped, assembled with 6/0 polydioxanone (PDS) uninterrupted sutures and then sutured to the albuginea defect. In our preliminary series of eight patients, penile shortening and erectile dysfunction is absent. Complete correction of penile deformity was achieved in seven patients (87.5%). One patient had minimal residual curvature (<20 degrees ) which did not result in difficulty with intromission. Saphenous harvesting by the stripping technique is not an invasive procedure and is quick and simple to perform. The W-shaped assembling technique is safe because the piece of saphena is kept intact and may be suited properly to the albuginea defect.

PMID: 11416831 [PubMed - indexed for MEDLINE]

Polydioxanone biodegradable pins in the knee: MR imaging.

AJR Am J Roentgenol. 2001 Jan;176(1):83-90

Authors: Sirlin CB, Boutin RD, Brossmann J, Pathria MN, Convery FR, Bugbee W, Resnick D

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.

PMID: 11133543 [PubMed - indexed for MEDLINE]

Clinical and histological results of septoplasty with a resorbable implant.

Arch Otolaryngol Head Neck Surg. 2000 Nov;126(11):1373-7

Authors: Boenisch M, Mink A

BACKGROUND: The use of a resorbable implant connected with septal cartilage would facilitate external septoplasty, offering mechanical stability until the cartilage fragments heal. OBJECTIVE: To study the histological and clinical results of septoplasty with a resorbable implant (polydioxanone [PDS; Ethicon, Norderstedt, Germany]) in conjunction with cartilage. DESIGN: To provide histological information in 5 rabbits, PDS foil was implanted into the outer ear in conjunction with an artificial cartilage defect. Observations were made at 2, 5, 10, 15, and 25 weeks. Resorption of the implant was investigated, including the time to complete elimination. In addition, septoplasty with PDS foil was performed on 71 patients with severe septal deformities. Surgery consisted of excision of the quadrilateral cartilage and division into straight fragments, which were sutured to the PDS foil and replaced as a free graft. SETTING: Ear, nose, and throat department of the General District Hospital Steyr, Steyr, Austria. RESULTS: Histological examination showed that the foil remained unchanged for at least 10 weeks and was completely resorbed after 25 weeks with minimal remaining scar tissue. Newly formed cartilage developed bordering the cartilage defect. In the clinical study, all patients experienced varying degrees of improvement in nasal blockage. No immediate or long-term complications occurred. CONCLUSIONS: The use of PDS foil in connection with cartilage facilitates surgical correction of severe septal deformities, additionally providing support for the nasal dorsum. The histological examination showed that no inflammatory or foreign body reaction occurred. Cartilage regeneration was even found. The foil was completely resorbed within 25 weeks, avoiding the long-term complications that occur with other artificial implants.

PMID: 11074836 [PubMed - indexed for MEDLINE]

Ligating clips for three-dimensional MR angiography at 1.5 T: in vitro evaluation.

Radiology. 2000 Mar;214(3):902-7

Authors: Weishaupt D, Quick HH, Nanz D, Schmidt M, Cassina PC, Debatin JF

Artifact size on three-dimensional (3D) magnetic resonance (MR) angiograms and safety of various vascular clips (15 titanium and three absorbable polydioxanone clips) were assessed. All evaluated clips were completely safe. Biodegradable clips rendered no artifacts; titanium clips were associated with susceptibility effects. Artifact size was dependent on clip size, clip orientation, echo time, and degree of k-space coverage. In the presence of titanium vascular clips, fast 3D MR angiography should be performed with the shortest echo time and full k-space coverage.

PMID: 10715066 [PubMed - indexed for MEDLINE]

The search for an ideal method of abdominal fascial closure: a meta-analysis.

Ann Surg. 2000 Mar;231(3):436-42

Authors: Hodgson NC, Malthaner RA, Ostbye T

BACKGROUND AND OBJECTIVE: The ideal suture for abdominal fascial closure has yet to be determined. Surgical practice continues to rely largely on tradition rather than high-quality level I evidence. The authors conducted a systematic review and meta-analysis of randomized controlled trials to determine which suture material and technique reduces the odds of incisional hernia. METHODS: MEDLINE and Cochrane Library databases were searched for articles in English published from 1966 to 1998 using the keywords "suture", "abdomen/surgery", and "randomized controlled trials". Randomized controlled trials, trials of adult patients, and trials with a Jadad Quality Score of more than 3, comparing suture materials, technique, or both, were included. Two independent reviewers critically appraised study quality and extracted data. The reviewers were masked to the study site, authors, journal, and date to minimize bias. The primary outcome was postoperative incisional hernia. Secondary outcomes included wound dehiscence, infection, wound pain, and suture sinus formation. RESULTS: The occurrence of incisional hernia was significantly lower when nonabsorbable sutures were used. Suture technique favored nonabsorbable continuous closure. Suture sinuses and wound pain were significantly lower when absorbable sutures were used. There were no differences in the incidence of wound dehiscence or wound infection with respect to suture material or method of closure. Subgroup analyses of individual sutures showed no significant difference in incisional hernia rates between polydioxanone and polypropylene. Polyglactin showed an increased wound failure rate. CONCLUSIONS: Abdominal fascial closure with a continuous nonabsorbable suture had a significantly lower rate of incisional hernia. The ideal suture is nonabsorbable, and the ideal technique is continuous.

PMID: 10714638 [PubMed - indexed for MEDLINE]

Prevention of Frey syndrome during parotidectomy.

Arch Otolaryngol Head Neck Surg. 1999 Aug;125(8):833-9

Authors: Dulguerov P, Quinodoz D, Cosendai G, Piletta P, Marchal F, Lehmann W

OBJECTIVE: To evaluate the incidence of Frey syndrome (auriculotemporal nerve syndrome) after parotidectomy with and without placement of a subcutaneous implant and to examine the relationship between different implants and postoperative wound complications (hematoma, seroma, salivary fistula). DESIGN: A prospective nonrandomized controlled trial. SETTING: A primary care and referral university hospital center. PATIENTS: All patients scheduled for parotidectomy from April 1994 through August 1998 were eligible. Seventy patients were enrolled (2 refused). All 70 patients were evaluated for wound complications. Sixty patients with a follow-up of more than 1 year were evaluated for Frey syndrome. INTERVENTION: The choice of implant was left to the individual surgeon: 24 patients had no implant; 7, lyophilized dura implant; 7, polyglactin 910-polydioxanone (Ethisorb) implant; and 32, expanded polytetrafluoroethylene (e-PTFE) implant. OUTCOME MEASURES: The incidence of Frey syndrome was evaluated (1) subjectively by history (clinical Frey syndrome) and (2) objectively by using 2 newly developed tests. Both hemifaces were tested, with the normal side being used as a control. RESULTS: Clinical Frey syndrome was present in 12 patients: 11 without implants (11/24 [53%]) and 1 with an implant (1/46 [2%]) (P<.001). Objective tests were positive in 24 patients: 16 (76%) of 21 without implants and 8 (20%) of 39 with implants (P<.001). In the implanted patients, the objective tests were positive in 71% (5/7) of those with lyophilized dura, 14% (1/7) of those with Ethisorb, and 8% (2/29) of those with e-PTFE implants (P<.001). Wound complications included hematoma in 5 patients (7%), seroma in 4 patients (6%), and salivary fistula in 15 (21%). Salivary fistula occurred more frequently with Ethisorb (57%) and e-PTFE (25%) implants (P = .04). CONCLUSIONS: In patients without an implant, the incidence of Frey syndrome is 50% for subjective and 80% for objective evaluation. In patients with an implant, these incidences are 3% and 10%, respectively. Some implants are associated with a higher incidence of salivary fistula.

PMID: 10448728 [PubMed - indexed for MEDLINE]

Mechanical strength of repairs of the rotator cuff.

J Bone Joint Surg Br. 1994 May;76(3):371-80

Authors: Gerber C, Schneeberger AG, Beck M, Schlegel U

We have studied the mechanical properties of several current techniques of tendon-to-bone suture employed in rotator-cuff repair. Non-absorbable braided polyester and absorbable polyglactin and polyglycolic acid sutures best combined ultimate tensile strength and stiffness. Polyglyconate and polydioxanone sutures failed only at high loads, but elongated considerably under moderate loads. We then compared the mechanical properties of nine different techniques of tendon grasping, using 159 normal infraspinatus tendons from sheep. The most commonly used simple stitch was mechanically poor: repairs with two or four such stitches failed at 184 N and 208 N respectively. A new modification of the Mason-Allen suture technique improved the ultimate tensile strength to 359 N for two stitches. Finally, we studied the mechanical properties of several methods of anchorage to bone using typically osteoporotic specimens. Single and even double transosseous sutures and suture anchor fixation both failed at low tensile loads (about 140 N). The use of a 2 mm thick, plate-like augmentation device improved the failure strength to 329 N. The mechanical properties of many current repair techniques are poor and can be greatly improved by using good materials, an improved tendon-grasping suture, and augmentation at the bone attachment.

PMID: 8175836 [PubMed - indexed for MEDLINE]

Formation of skeletal muscle in vivo from the mouse C2 cell line.

J Cell Sci. 1992 Aug;102 ( Pt 4):779-87

Authors: Morgan JE, Moore SE, Walsh FS, Partridge TA

The C2 muscle cell line is myogenic in vitro and has been extensively used in studies of muscle cell differentiation. Here, we have investigated the myogenicity in vivo of C2 cells implanted into suitable sites in the mouse. Large amounts of new muscle were formed when C2 cells were implanted into sites in nude mice which were undergoing regeneration following whole muscle grafting and in scaffolding of freeze-killed muscle or vicryl suture in the anterior tibial compartment. When implanted into regenerating muscle, C2 cells fused with the host muscle to form mosaic fibres; when implanted into inert sites, they formed muscle of largely donor origin. C2-derived muscle fibres appeared to become innervated, but the progression of N-CAM (neural cell adhesion molecule) isoform changes in such regenerates indicated that they did not become fully mature. Proliferating, undifferentiated cells of C2 origin form tumours in older grafts; however, this was more pronounced in the absence of competition from host muscle cells. In the short term, C2 cells can form large amounts of muscle in vivo for biochemical analysis. In addition, C2 cells are easily manipulable in vitro; genes of interest may be transfected into them prior to implantation of the cells into skeletal muscle and the effects of these genes in vivo may thus be examined.

PMID: 1429891 [PubMed - indexed for MEDLINE]

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

J Bone Joint Surg Br. 1992 Mar;74(2):292-6

Authors: Plaga BR, Royster RM, Donigian AM, Wright GB, Caskey PM

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.

PMID: 1544972 [PubMed - indexed for MEDLINE]

Stabilisation of refraction following extracapsular cataract extraction.

Br J Ophthalmol. 1990 Aug;74(8):486-9

Authors: Baranyovits P

Regular serial refraction was used to determine the rate of stabilisation of refraction following routine extracapsular cataract surgery in 85 eyes. Patients were divided into four groups depending on wound closure technique: limbal section closed by interrupted 8-0 virgin silk, 9-0 polydioxanone or 10-0 nylon sutures, and corneal section closed by continuous 10-0 nylon suture. Stabilisation of refraction, sufficient to prescribe satisfactory glasses, occurred at three months except in the interrupted 10-0 nylon group, when stabilisation was delayed to between four and five months. The factors affecting stabilisation and the causes of the differences observed are discussed.

PMID: 2202435 [PubMed - indexed for MEDLINE]

Use of absorbable sutures in canine carotid arteries.

Tex Heart Inst J. 1990;17(2):99-102

Authors: Rey AR, Carrillo-Farga J, Velasco CO, Valencia MO

To study the functional and microstructural characteristics of polydioxanone sutures in vascular surgery, we created 48 vascular anastomoses in the right and left common carotid arteries of 24 mongrel dogs. In each animal, polydioxanone sutures were used in 1 carotid artery, and polypropylene sutures were used in the contralateral carotid artery. Twelve groups of 2 animals each were then formed. The 1st group was observed for 1 month, the 2nd for 2 months, the 3rd for 3 months, and so on until the 12th group, which was observed for 12 months. At the end of each observation period, reoperation was undertaken to evaluate the vascular anastomoses by means of angiography and microscopy. The polypropylene anastomoses showed a marked deformity, with tissue retraction and a foreign body reaction. In contrast, the polydioxanone anastomoses exhibited satisfactory healing, without deformity, and were well tolerated histologically. We believe that polydioxanone may be a useful, alternative vascular suture material.

PMID: 15227391 [PubMed]

Surgical ligation clip artifacts on CT scans.

Radiology. 1985 Sep;156(3):831-2

Authors: Gross SC, Kowalski JB, Lee SH, Terry B, Honickman SJ

Surgical ligation clips of various materials were scanned in a water-filled phantom to determine what artifacts would be produced. Tantalum clips produced severe image degradation, while stainless steel clips produced less severe degradation. Minimal artifacts were observed with titanium clips. Clips molded from an absorbable polymeric material, polydioxanone, were visible on computed tomography (CT) scans and had the least effect on the CT image.

PMID: 4023253 [PubMed - indexed for MEDLINE]

Assessment of sutures for use in colonic surgery: an experimental study.

J R Soc Med. 1984 Jun;77(6):472-7

Authors: Durdey P, Bucknall TE

Following injury, normal colon takes approximately 30 days to regain full breaking strength. This healing period can be lengthened by local infection. Colonic anastomoses are likely to be contaminated by intraluminal organisms, and suture material in such a situation is known to potentiate the development of sepsis. Experiments were designed to evaluate six suture materials used in colonic surgery to determine which retained adequate tensile strength and which excited least inflammatory response. The results indicate that absorbable sutures, with the exception of polydioxanone, lose strength too rapidly for use alone. Braided materials, notably silk, produce a prolonged tissue response and harbour bacteria. Monofilament materials are unreactive and appear least likely to delay healing. Polydioxanone, which is monofilament and absorbable, is recommended for use in the colon.

PMID: 6429330 [PubMed - indexed for MEDLINE]

New absorbable explants using gelatin and synthetic materials.

Trans Am Ophthalmol Soc. 1983;81:966-1033

Authors: Wilson RS

PMID: 6328720 [PubMed - indexed for MEDLINE]