Fibrin sealant use in thyroidectomy: A prospective, randomized, placebo-controlled double blind trial using EVICEL

Joshua D. Hornig, M. Boyd Gillespie, Eric J. Lentsch, Colin W. Fuller, Jackson Condrey, Shaun A. Nguyen
2016 Otorhinolaryngology-Head and Neck Surgery  
Objectives: To evaluate EVICEL fibrin sealant used in thyroid surgery closure. Primary endpoints were post-operative drain output, time to drain removal, length of admission and adverse events. Study design: A prospective, randomized, double-blind, placebo-controlled study. Settings: Subjects seen in the , an IRB-approved prospective, randomized, double-blind study of EVICEL versus a saline control was conducted on 70 subjects receiving total thyroidectomy or hemithyroidectomy. 28 received
more » ... l and 27 received saline; data from fifteen subjects were eliminated due to protocol violations. The mean age was 50.3 (range 21 to 73). Results : There was no significant difference in drain output between Evicel (median[interquartile range]: 96.3 mL [73.3-139.3 mL]) and placebo (120.0 mL [68.8-161.5 mL], p=0.334). Drain time (37.9 hrs [25.2-48.7 hrs] vs. 43.6 hrs [37.6-58.1 hrs]) and hospital stay (45.5 hrs[33.4-53.8 hrs] vs. 50.9 hrs[44.1-69.4 hrs]) were also shorter for Evicel, but again these differences were not significant (p=0.101 and 0.526 respectively). For total thyroidectomy subgroup there was a significant reduction in drain output (103.5 mL [80.0-138.6 mL] vs. 150.0 mL[120.0-188.5 mL], p=0.035) and drain time (40.3 hrs [26.2-49.1 hrs] vs. 47.1 hrs [42.0-67.8], p=0.035) with Evicel. Hospital stay in this subgroup was shorter with Evicel (50.3 hrs [43.6-54.9 hrs] vs. 59.4hrs [48.4-70.6 hrs]), but this result was not significant (p=0.246). No outcomes were significant in the hemithryoidectomy subgroup. Nine adverse events occurred in the Evicel group compared to three for placebo (p=0.101). Conclusion : Evicel sealant appears to be a safe, effective method to reduce serous drain output following total thyroidectomy, but has a limited role in hemithyroidectomy due to low levels of baseline drain output. Hornig JD (2016) Fibrin sealant use in thyroidectomy: A prospective, randomized, placebo-controlled double blind trial using EVICEL Volume 1(1): 21-24
doi:10.15761/ohns.1000106 fatcat:6jacjkjcv5dnlcg44x2nqgkyuu