Protein-based tissue adhesive reduces time to haemostasis in peripheral vascular surgery.

ABSTRACT

OBJECTIVES: The aim of this study was to evaluate the effectiveness of protein-based tissue adhesive (Bioglue®) in reducing time to haemostasis in patients undergoing peripheral vascular surgery. METHODS: From January to December 2021, 100 consecutive patients from 4 centres have been treated with open peripheral vascular surgery including upper and lower limb interventions. Patients have been allocated in each centre into control with no use of Bioglue® (Group no-Bio, 50 patients) or use of Bioglue® (Group Bio, 50 patients) by a block randomization method 1010 until the required sample size was reached. Perioperative parameters including time to haemostasis, number of adjunctive stitches, and in-hospital bleeding have been analysed and compared in the two groups by means of mean independent-samples tT -test and Gehan-Breslow-Wilcoxon test. RESULTS: Both groups were homogeneous in terms of demographic data, preoperative risk factors, and preoperative medical therapy except for a higher percentage of active smokers in Group Bio (52% vs. 24%, p = 0.004). Femoral endarterectomy was most common in Group Bio (44% vs. 24%, p = 0.03), whilst the percentage of lower limb vein bypasses was higher in Group no-Bio (50% vs. 36%, p = 0.03). Bovine pericardium was the preferred material in Group Bio (20 cases, 40%), whilst autologous vein is mostly used in Group no-Bio (26 cases, 52%) (p = 0.01). Time to haemostasis was faster in Group Bio (4.4 vs. 9.6 minutes, p < 0.001). The need for adjunctive stitches was higher in Group no-Bio (8 cases, 16%, Group Bio vs. 25 cases, 50%, Group no-Bio; p < 0.001). The overall rate of in-hospital bleeding, including those requiring reintervention, was not different between the two groups (9 cases, 18%, Group Bio vs. 7 cases, 14%, Group no-Bio; p = 0.39). CONCLUSIONS: The protein-based tissue adhesive Bioglue® reduced time to haemostasis and need for adjunctive stitches in peripheral vascular surgery. However, it did not affect the overall rate of perioperative bleedings. Further studies with larger sample sizes are needed to validate these outcomes.