NCT01226914

A Trial Comparing Wound Drainage and Post-operative Complications With and Without the Use of EVICEL™ Fibrin Sealant in Thyroidectomy

A Randomized, Double-Blind, Placebo-Controlled Trial Comparing Wound Drainage and Post-operative Complications With and Without the Use of EVICEL™ Fibrin Sealant in Thyroidectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Medical University of South Carolina · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Primary Objectives * To compare the amount of post-operative wound drainage between the group of patients in which EVICEL™ spray is utilized (Arm A), and the group of patients in which an EVICEL™ placebo is utilized (Arm B). * To compare the length of time to drain removal between Arm A and Arm B. Secondary objectives * To compare the incident or rates of seroma, hematoma, and post-operative edema between the two groups. * To compare the reported pain experienced in each group at selected time points using a standard numerical rating scale (NRS). * To compare the length of hospital stay between the two groups of patients.

Conditions

• Thyroid Neoplasm
• Goiter

Interventions

Type	Name	Description
DRUG	EVICEL	EVICEL

Timeline

• Start date: 2010-06-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2010-10-22
• Last updated: 2019-02-05
• Results posted: 2019-02-05