BACKGROUND:ePTFE patch reconstruction has superior flow characteristics in preventing early thrombus formation during carotid endarterectomy. However prolonged bleeding at the suture line of the patch reconstruction is a problem. The aim of this study was to investigate whether the application of gelatine-resorcine-formol (GRF) glue at the suture line can improve local haemostasis. METHODS: A prospective randomised trial of 40 consecutive patients undergoingcarotid endarterectomy was undertaken. Patients were randomised to receive GRF glue as a topical haemostatic agent or to act as controls. Statistical analysis was performed using the Mann-Whitney test. RESULTS: Although the patch size was significantly smaller in the control group (3.0 cm2 vs 4.3 cm2, p<0.001), local haemostasis was achieved in half the time when the glue was used (11 min vs 22, p<0.004). In the follow-up period ranging from 12 to 24 months, there have been no adverse effects related to the glue. Two patients died during the follow-up period. These deaths were neither related to the patch nor to the glue. CONCLUSIONS: This study has shown that GRF glue is an effective sealant of ePTFE patch suture line. GRF glue does not compromise the patch's characteristics.
RCT Entities:
BACKGROUND: ePTFE patch reconstruction has superior flow characteristics in preventing early thrombus formation during carotid endarterectomy. However prolonged bleeding at the suture line of the patch reconstruction is a problem. The aim of this study was to investigate whether the application of gelatine-resorcine-formol (GRF) glue at the suture line can improve local haemostasis. METHODS: A prospective randomised trial of 40 consecutive patients undergoing carotid endarterectomy was undertaken. Patients were randomised to receive GRF glue as a topical haemostatic agent or to act as controls. Statistical analysis was performed using the Mann-Whitney test. RESULTS: Although the patch size was significantly smaller in the control group (3.0 cm2 vs 4.3 cm2, p<0.001), local haemostasis was achieved in half the time when the glue was used (11 min vs 22, p<0.004). In the follow-up period ranging from 12 to 24 months, there have been no adverse effects related to the glue. Two patients died during the follow-up period. These deaths were neither related to the patch nor to the glue. CONCLUSIONS: This study has shown that GRF glue is an effective sealant of ePTFE patch suture line. GRF glue does not compromise the patch's characteristics.