Evaluation of TLC-NOSF dressing with poly-absorbent fibres in exuding leg ulcers: two multicentric, single-arm, prospective, open-label clinical trials.

OBJECTIVE: To assess the efficacy, safety and acceptability of a new TLC-NOSF dressing with poly-absorbent fibres in the management of exuding leg ulcers, at the different stages of healing. METHOD: This work presents the results of two prospective, multicentric clinical studies: NEREIDES and CASSIOPEE. Patients with a non-infected, moderate-to-strongly exudating leg ulcer of venous or mixed origin, were treated with the dressing and an appropriate compression system for 12 weeks. The wounds included in NEREIDES had to be in debridement stage, and those in CASSIOPEE at granulation stage. In both studies, the primary outcome was the relative wound area reduction (RWAR) at week 12. Main secondary outcomes included healing rate, time-to-reach wound closure, adverse events and acceptability of the dressing by patients and health professionals. RESULTS: There were 37 patients included in NEREIDES and 51 in CASSIOPEE. The two cohorts presented similar patient and wound characteristics, except from the percentage of sloughy tissue on wound bed at baseline (median: 75% NEREIDES and 30% CASSIOPEE). At week 12, the RWAR (60% NEREIDES and 81% CASSIOPEE), wound closure rates (18% NEREIDES and 20% CASSIOPEE) and mean times-to-reach wound closure (58±27 days NEREIDES and 55±23 days CASSIOPEE) supported the beneficial outcomes of the treatment in both cohorts. In patients with a wound duration ≤6 months, the wound area reduction reached 85% in NEREIDES and 81% in CASSIOPEE, highlighting the importance to initiate adequate treatment as soon as possible. The nature and frequency of the local adverse events were similar in both studies and consistent with the good safety profiles of the poly-absorbent fibres and of the TLC-NOSF dressings. The acceptability of the dressing (easy to apply, conformable and non-adherent to the wound bed at removal, with no pain or bleeding at removal) has been judged 'very good' or 'good' at each stage of the healing process, by both nursing staff and patients. CONCLUSION: These clinical results establish the new TLC-NOSF dressing with poly-absorbent fibres (UrgoStart Plus, Laboratoires Urgo) as an effective, safe and simple treatment for the local management of leg ulcers, at the different stages of healing and until wound closure.

Long-term outcome of femoral above-knee popliteal artery bypass using autologous saphenous vein versus expanded polytetrafluoroethylene grafts.

Despite a recent flurry of publications on preferred techniques for femoral above-knee popliteal artery bypass, controversy persists over the use of autologous saphenous vein and expanded polytetrafluoroethylene (ePTFE) grafts. The purpose of this study was to compare our long-term results using these two bypass materials. In a series of 474 infrainguinal bypasses performed between January 1993 and December 1998, we performed a total of 75 femoral above-knee popliteal artery bypass using an autologous saphenous vein graft in 48 cases (64%) and an ePTFE graft in 27 cases (36%). Prosthetic grafts were used by choice in 17 cases and by necessity due to the absence of useable vein in 10 cases. There were 55 men and 18 women with a mean age of 70 years. The indication for bypass was lower extremity arterial occlusive disease at stage II in 17 cases (22.7%), stage III in 9 cases (12%), and stage IV in 36 cases (48%); subacute ischemia in 8 cases (10.7%); and femoropopliteal aneurysm in 5 cases (6.7%). Preoperative arteriography demonstrated three patent leg arteries in 15.5% of cases, two patent leg arteries in 43.5%, and one patent leg artery in 41%. There was no significance difference between the vein graft and ePTFE graft groups with regard to indications and arteriographic findings. No patient died during the immediate postoperative period. The mean duration of follow-up was 25.5 months (range, 3 to 108 months). The primary patency rate at 4 years was 82.2 +/- 8% for venous bypass vs. 80.6 +/- 11.8% for ePTFE bypass (p = 0.42). The secondary patency rate at 4 years was 84.7 +/- 7.4% for vein bypasses and 79.5 +/- 12% for ePTFE bypasses (p = 0.26). In our experience, there was no statistically significant difference in long-term outcome of femoral above-knee popliteal artery bypass using autologous vein grafts or prosthetic ePTFE grafts.

Importance of a arteriography for intraoperative quality control during carotid artery surgery.

The purpose of this study was to determine the impact of intraoperative quality control using arteriography on the conduct and immediate outcome of carotid artery surgery. This retrospective study included 623 carotid artery repair procedures performed between January 1993 and January 2000. There were 427 men and 159 women (37 bilateral procedures) with a mean age of 71.6 years. The repair technique consisted of conventional endarterectomy alone in 353 cases, conventional endarterectomy with patch closure in 95 cases, eversion in 44 cases, and vein (n = 105) or prosthetic (n = 26) grafting in 131 cases. Findings of intraoperative arteriography, which is used routinely in our department, were reviewed and analyzed in all cases. Our findings indicate that intraoperative quality control with arteriography is an important part of carotid artery surgery. In 11.7% of cases in this study, intraoperative arteriography revealed significant defects that are the main cause of postoperative neurological complications.

Outcome of common iliac arteries after aortoaortic graft placement during elective repair of infrarenal abdominal aortic aneurysms.

PURPOSE: The purpose of this study was determination of the expansion rates relative to the size of the common iliac artery (CIA) after elective placement of a straight aortic tube graft for an infrarenal abdominal aortic aneurysm (AAA). METHODS: Between January 1993 and December 1997, 74 men (mean age, 69 years) with AAA underwent surgical repair with a straight tube graft. All patients underwent preoperative and postoperative computed tomography (CT) scans. The mean follow-up period was 68.3 months. The preoperative CT scan revealed a dilatation of at least one of the two CIAs in 32 patients (43.2%; group A). Within this group, the CIA was ectatic (12 mm < diameter < 18 mm) in 13 patients (subgroup A1) and aneurysmal (diameter >/=18 mm) in 19 patients (subgroup A2). The diameters of both CIAs were normal (diameter