A Double-Blind, Randomized, Placebo-Controlled Clinical Trial Evaluating Fibrin Sealant in Thyroidectomy Closure

Objectives:Evaluate the advantages and disadvantages of Evicel fibrin sealant when used in thyroid surgery closure, taking into account the following endpoints: postoperative drain output, time to drain removal, length of admission, and adverse events.Methods:From June 2010 to January 2014, an institutional review board–approved prospective, randomized, double-blind study of Evicel versus a saline control was conducted on 70 subjects receiving total thyroidectomy or hemithyroidectomy. Twenty-eight received Evicel and 27 received saline; data from 15 subjects were eliminated due to protocol violations. The mean age was 50.3 (range, 21 to 73).Results:Comparisons of baseline characteristics, including age, sex, and type of surgery, revealed successful subject randomization. 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 = .334). Drain time (37.9 hours [25.2-48.7 hours] vs 43.6 hours [37.6-58.1...