Randomised Controlled Trial to Evaluate the Efficacy of TachoComb H Patches in Controlling PTFE Suture–hole Bleeding

• Published in: European journal of vascular and endovascular surgery Vol. 27; no. 5; pp. 549 - 552
• Main Authors: Joseph, T., Adeosun, A., Paes, T., Bahal, V.
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.05.2004
• Subjects: Aged; Aged, 80 and over; Anastomosis, Surgical; Animals; Coated Materials, Biocompatible; Collagen; Drug Delivery Systems; Efficacy; Female; Fibrinogen - administration & dosage; Haemostasis; Hemostasis, Surgical - instrumentation; Horses; Humans; Intraoperative Complications - therapy; Male; Middle Aged; Polytetrafluoroethylene; Polytetrafluoroethylene (PTFE); Prospective Studies; Surgical Sponges; Suture–hole bleeding; TachoComb ® H; Thrombin - administration & dosage; Vascular Surgical Procedures; Suture–hole bleeding; Efficacy; Polytetrafluoroethylene (PTFE); Haemostasis; TachoComb ® H
• ISSN: 1078-5884; 1532-2165
• DOI: 10.1016/j.ejvs.2004.01.018

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.