A Gelatin-Thrombin Matrix Topical Hemostatic Agent (Floseal) in Combination With Harmonic Scalpel Is Effective in Patients Undergoing Total Thyroidectomy: A Prospective, Multicenter, Single-Blind, Randomized Controlled Trial

Surg Innov. 2016 Feb;23(1):23-9. doi: 10.1177/1553350615596638. Epub 2015 Aug 3.

Abstract

Background: Hemostasis during thyroidectomy is essential; however, the safest, most efficient, and most cost-effective way to achieve this is unclear. This randomized, multicenter, single-blind, prospective study evaluated the efficacy and safety of using different hemostatic approaches in patients undergoing total thyroidectomy.

Methods: Patients aged ≥18 to 70 years were randomized to Floseal + a harmonic scalpel (HS), Floseal alone, HS alone, or standard total thyroidectomy. Primary endpoint was 24-hour drain output. Secondary endpoints included surgery duration and complications.

Results: Two hundred and six patients were randomized to Floseal + HS (n = 52), Floseal alone (n = 54), HS alone (n = 50), and standard total thyroidectomy (n = 50). The 24-hour drain output was lower in the Floseal + HS group compared with standard thyroidectomy. Floseal + HS also had a shorter surgery time (P < .0001) versus the other 3 treatments.

Conclusion: Floseal + HS can be effective at reducing postsurgical drain output and provides a complementary hemostatic approach in patients undergoing total thyroidectomy.

Keywords: Floseal; gelatin–thrombin matrix; harmonic scalpel; hemostatic agent; total thyroidectomy.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Female
  • Gelatin / therapeutic use
  • Gelatin Sponge, Absorbable / therapeutic use*
  • Hemostatics / therapeutic use*
  • Humans
  • Male
  • Middle Aged
  • Prospective Studies
  • Surgical Instruments*
  • Thrombin / therapeutic use
  • Thyroidectomy / adverse effects
  • Thyroidectomy / instrumentation*
  • Thyroidectomy / methods
  • Thyroidectomy / statistics & numerical data*
  • Treatment Outcome

Substances

  • FloSeal Matrix
  • Hemostatics
  • Gelatin
  • Thrombin