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

Abstract

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 hours]) and hospital stay (45.5 hours [33.4-53.8 hours] vs 50.9 hours [44.1-69.4 hours]) were also shorter for Evicel, but again these differences were not significant (P = .101 and .526, respectively). For the subjects undergoing total thyroidectomy, 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 = .035) and drain time (40.3 hours [26.2-49.1 hours] vs 47.1 hours [42.0-67.8 hours], P = .035) with Evicel. Hospital stay in this subgroup was shorter with Evicel (50.3 hours [43.6-54.9 hours] vs 59.4 hours [48.4-70.6 hours]), but this result was not significant (P = .246). No outcomes were significant in the hemithryoidectomy subgroup. Nine adverse events occurred in the Evicel group compared to 3 for placebo (P = .101).

Conclusions:

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.