CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 55 enrolled
Drug / intervention
EVICELdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01226914
NCT01226914N/ACompleted

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

Medical University of South Carolina·interventional·Posted Oct 22, 2010·Updated Feb 5, 2019

In Brief

A clinical study evaluating EVICEL for Thyroid Neoplasm and Goiter. Completed, enrolled 55 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
CollaboratorsEthicon, Inc.

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 22, 2010
Enrollment StartJun 1, 2010
Primary CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 15.7 years ago

Interventions

EVICELdrug

EVICEL