To evaluate the efficacy of an acellular Flowable matrix in comparison with a wet dressing for the treatment of patients with diabetic foot ulcers: a randomized clinical trial.

The authors aimed to evaluate the efficacy of an advanced wound matrix (Integra Flowable Wound Matrix, Integra LifeScience Corp, Plainsboro, NJ, USA) for treating wounds with irregular geometries versus a wet dressing in patients with diabetic foot ulcers. Sixty patients with diabetic foot ulcers (Grades 3 Wagner) were included in this randomized clinical trial. The study was conducted in the General Surgery Unit and Geriatric of the Second University of Naples, Italy, in the last 12 months. Forty-six cases of diabetic foot ulcers were equally and randomly divided into control and test groups. The first group treated with Integra Flowable Wound Matrix, while the control group with a wet dressing. Both groups were evaluated once a week for 6 weeks to value the degree of epithelialization and granulation tissue of the wound. The complete healing rate in the whole study population was 69.56% (Integra Flowable Wound Matrix group, 86.95%, control group, 52.17%; p = 0.001). Amputation and rehospitalization rates were higher in the control group compared to the first group, therefore, the difference was statistically significant (p = 0.0019; p = 0.028, respectively). The Integra Flowable Wound Matrix, was significantly superior, compared to the wet dressing, by promoting the complete healing of diabetic foot ulcers. Ease of use, absence of adverse effects, and a facilitated wound healing process are among the properties of the matrix. These characteristics make it appropriate in the management of diabetic foot ulcers. Additional research will shed more light on the promising advantages of this material in healing diabetic foot ulcers.

Enzymatic debridement: is HA-collagenase the right synergy? Randomized double-blind controlled clinical trial in venous leg ulcers.

OBJECTIVE: The aim of this study is to evaluate the efficacy and safety of a new ointment containing Hyaluronic Acid and collagenase from non-pathogenic Vibrio alginolyticus. PATIENTS AND METHODS: Double blind, multicenter, controlled clinical trial (no. ISRCTN71239043) conducted to demonstrate the superiority of Hyaluronic Acid-Collagenase applied once a day over placebo in mean reduction of devitalized/fibrinous/slough tissue after 15 days of treatment. 113 patients with venous ulcers were enrolled and randomized to receive active treatment therapy or vehicle preparation. Both arms also received compression therapy. Subjects were assessed at baseline and at 4 different clinical study visits up to a maximum of 30 days. Outcome measures included mean percentage debridement evaluated by digital planimetry, pain during change of dressing measured on a visual analogue scale and adverse event assessment for tolerance. RESULTS: After 15 days the debridement rate in the active group was 67.5% compared to 59% in the placebo group (p = 0.0436). A significantly higher number of patients in the treatment group achieved 100% debridement by day 15 (p = 0.0025) than in the control group, and a higher percentage also demonstrated complete debridement at every other time point. Pain perception was similar in both groups with low levels during medication. No differences in tolerance were observed between groups. CONCLUSIONS: Chronic venous ulcers treated with this novel compound of Hyaluronic Acid and collagenase resulted in a significantly higher debridement rate at Day 15 vs. the control group. Hyaluronic Acid-Collagenase was well tolerated and a low degree of pain was perceived during dressing change. The preparation of 0.2% of Hyaluronic acid-collagenase shows significant benefits in the management of chronic ulcers.

Mesh fixation with human fibrin glue (Tissucol) in open tension-free inguinal hernia repair: a preliminary report.

BACKGROUND: The Lichtenstein technique for inguinal hernia repair is easy to learn and associated with few complications. However, recent studies have suggested that this technique is inferior to some 'sutureless' repair systems in terms of perceived difficulty, operating time, surgeon satisfaction, etc. METHODS: We employed a sutureless Lichtenstein technique in 80 consecutive patients with primary unilateral inguinal hernia, to assess patient and trainee surgeon outcomes. Human fibrin glue was used in place of conventional sutures. RESULTS: The mean operating time was 36 min and all patients were discharged 5-6 h after the operation. On a 100-point visual analogue scale, the surgeons rated the difficulty of the operation as low (mean score, 31), and perceived satisfaction as high (mean score, 84). No complications were observed at 12-month follow-up. CONCLUSION: This study confirms the efficacy of mesh fixation with human fibrin glue, and supports the viability of a sutureless Lichtenstein procedure.

[Blood coagulation changes in patients with post-splenectomy persistent thrombocytosis]. / Le alterazioni emocoagulative nei pazienti con trombocitosi persistente post-splenectomia.

To clarify the possible role of persistent thrombocytosis after splenectomy as being a predisposing factor causing thromboembolism. Blood coagulation profiles were studied in 35 patients (20 M and 15 F, mean age 42 +/- 17.5) suffering from thrombocytosis (> 500,000/dl) who underwent splenectomy for non-malignant and non-traumatic diseases. Seventy healthy subjects acted as a control group. Tests were performed 6 months after the operation and for both groups (patients and controls) blood samples were collected for: platelets, fibrinogen, PT, APTT, AT III, plasminogen, F1 + 2, t-PA and DNA analysis for F V, F II and MTHFR. After one year all subjects were controlled for thrombocytosis, genomic abnormalities and venous thrombosis. All the analyses were performed according to the Statistical Package for Social Science. The significance of the differences in means was evaluated by non-parametric tests, differences with a P value < 0.05 being considered significant. Increased plasma levels of fibrinogen, D-dimer, F1 + 2 and PAI-1 were found in the patients compared with the control group. TPA was significantly lower in the patients than in the controls. At the one year follow-up, two patients with genetic polymorphism had suffered deep venous thrombosis. Our findings indicate that splenectomy contributes to abnormal platelet aggregation and endothelial cell activation with hypercoagulability.

Sutureless skin closure in varicose vein surgery: preliminary results.

OBJECTIVE: To describe the preliminary results of a special method of wound closure in varicose vein surgery using the tissue adhesive butyl-2-cyanoacrylate. METHODS: Eighteen consecutive young women (mean age 23 years) underwent partial stripping of the greater saphenous vein for varicose veins of the lower limbs by an external phleboextractor. Their wounds were closed without sutures by means of the adhesive butyl-2-cyanoacrylate. The cutaneous edges were drawn together by linear traction between forceps and the adhesive was applied and allowed to set. Less than 0.5 ml of adhesive was required to complete the entire procedure. Wounds were evaluated at 7 days for infection, dehiscence, and tissue reactions. At 6 months all wounds were rated for cosmesis using a validated visual analog scale, that is, a 100 mm line with "worst scar" at the right end of the line and "best scar" at the left end. All patients were interviewed about their acceptance of tissue adhesive skin closure. RESULTS: The mean time required to close the epidermis with the adhesive was 117 seconds. All patients were followed up for 6 months. At 7 days no adverse outcomes had occurred. Results of wound evaluation at 6 months by the visual analog scale showed scores of 22.2 +/- 13.8 mm (optimal). The percentage of optimal scores was 94.4%, and only one patient (5.6%) had a suboptimal score. Inquiry into the patient's opinions suggested that this procedure was very acceptable. CONCLUSION: Preliminary results with sutureless skin closure in varicose vein surgery have been very encouraging. This fast and cosmetic method of wound repair can replace the need for skin sutures in varicose vein surgery.

Diagnostic and surgical approaches to recurrent varicose veins of lower limbs.

A consecutive series of 82 patients (98 legs) suffering from recurrent varicose veins underwent surgical treatment. In all patients clinical and hand-held US Doppler preoperative examinations were performed, but a phlebography was necessary in 33 legs to certainly visualize the anatomy of venous system and the potential sites of recurrent deep to superficial reflux. The causes of recurrence were: incompetent saphenofemoral junction in 59 legs, saphenopopliteal reflux in 6 legs, incompetence of perforator veins in 18 legs, both insufficiencies of great saphena and perforators in 15 legs. Seventy-four legs with saphenofemoral reflux underwent groin redissections through transversal (44 legs) or vertical (30 legs) incisions; the approach to the saphenopopliteal junction was vertical in two legs and transversal in four legs; the interruption of incompetent perforator veins was performed through incisions in 29 legs and according to Linton's technique in 4 legs. Clinical and US Doppler follow-up was performed every 6 months and no recurrent reflux was demonstrated; seven patients were affected from new small varices that were treated by injection sclerotherapy. This study indicates that more than 1/3 of recurrent varices need phlebography to be clearly studied: only diagnostic accuracy may assure a correct surgical approach, but the strategy of treatment must be adapted to the single patient.