Randomised controlled trial to evaluate the efficacy of TachoComb H patches in controlling PTFE suture-hole bleeding.

OBJECTIVE: Suture-hole bleeding is a considerable problem in vascular procedures using polytetrafluoroethylene (PTFE) grafts. This study aimed to study the efficacy of TachoComb H patches in controlling suture-hole bleeding. DESIGN: Prospective randomised controlled trial. Materials and methods. Patients undergoing femoral anastomosis and femoral or carotid patch angioplasty with PTFE grafts were prospectively randomised to TachoComb H patches or standard compression with surgical swabs. RESULTS: Twenty four patients were randomised (12 patients in each treatment group). The median time to haemostasis was 300 (range 180-600)s in patients treated with TachoComb H and 660 (range 180-1200)s in the control group. The log rank test of equality over treatments based on the 22 patients with assessment of time to haemostasis showed statistical significance (p=0.0134). There were no serious complications associated with use of TachoComb H patches. CONCLUSION: TachoComb H patches were found to be safe and effective for the control of suture-hole bleeding in patients undergoing vascular reconstruction with PTFE grafts.