A Double‐Blind, Randomized, Placebo‐Controlled Clinical Trial Evaluating Fibrin Sealant in Thyroidectomy Closure. (2nd September 2014)

• Record Type: Journal Article
• Authors: Fuller, Colin W.; Gillespie, M. Boyd; Nguyen, Shaun A.; Jones, Taylor; Hornig, Joshua D.
• Is Part Of: Otolaryngology--head and neck surgery. Volume 151(2014)Supplement 1
• Page Start: P160
• Page End: P161
• Publication Date: 2014-09-02
• Subjects: Head -- Surgery -- Periodicals; Neck -- Surgery -- Periodicals; Otolaryngology -- Periodicals; 617.51
• DOI: 10.1177/0194599814541629a75
• Languages: English
• ISSNs: 0194-5998

Abstract

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.