OBJECTIVES: To determine whether topical fibrin sealant reduced suture line bleeding during carotid endarterectomy with polytetrafluoroethylene (PTFE) patch closure. DESIGN: Prospective randomised non-blinded control trial. SETTING: Regional vascular surgery unit. MATERIALS: Seventeen patients undergoing carotid endarterectomy were randomised either to receive fibrin sealant as a topical haemostatic agent at the arteriotomy suture line or to act as control. OUTCOME MEASURES: Time taken to achieve haemostasis at the suture line. Intraoperative blood loss. Total operative time. RESULTS: The median time to achieve haemostasis was 5.5 min (range 4-31 min) in the treatment group and 19 min (range 10-47 min) in the control group. This difference was statistically significant p < 0.005 by Mann-Whitney test. There was no statistical difference in total operative time. Operative blood loss was lower in the treatment group (median 420ml, range 300-500ml) than in the control group (median 550ml, range 350-1200ml) but this difference was not statistically significant. One patient in the control group suffered a perioperative thrombo-embolic event. CONCLUSION:Fibrin sealant is an effective topical haemostatic agent for arteriotomy suture lines involving PTFE material.
RCT Entities:
OBJECTIVES: To determine whether topical fibrin sealant reduced suture line bleeding during carotid endarterectomy with polytetrafluoroethylene (PTFE) patch closure. DESIGN: Prospective randomised non-blinded control trial. SETTING: Regional vascular surgery unit. MATERIALS: Seventeen patients undergoing carotid endarterectomy were randomised either to receive fibrin sealant as a topical haemostatic agent at the arteriotomy suture line or to act as control. OUTCOME MEASURES: Time taken to achieve haemostasis at the suture line. Intraoperative blood loss. Total operative time. RESULTS: The median time to achieve haemostasis was 5.5 min (range 4-31 min) in the treatment group and 19 min (range 10-47 min) in the control group. This difference was statistically significant p < 0.005 by Mann-Whitney test. There was no statistical difference in total operative time. Operative blood loss was lower in the treatment group (median 420ml, range 300-500ml) than in the control group (median 550ml, range 350-1200ml) but this difference was not statistically significant. One patient in the control group suffered a perioperative thrombo-embolic event. CONCLUSION: Fibrin sealant is an effective topical haemostatic agent for arteriotomy suture lines involving PTFE material.
Authors: Hamidreza Fonouni; Arash Kashfi; Ali Majlesara; Oliver Stahlheber; Lukas Konstantinidis; Thomas W Kraus; Arianeb Mehrabi; Hani Oweira Journal: J Mater Sci Mater Med Date: 2017-07-28 Impact factor: 3.896