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

January 14, 2019 updated by: Shaun A. Nguyen, Medical University of South Carolina

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Patients must have an initial diagnosis of thyroid neoplasmcarcinoma or goiter that requires total or hemithyroidectomy.
  • Patients must have an ECOG performance status of 0-2

  • Laboratory values must be within the following ranges:

    • Platelet count > 100 k/mm3
    • Hemoglobin > 10.0 g/dL
    • WBCs > 3.0 k/mm3
    • Total bilirubin < 2.6
    • Serum Creatinine < 2.0
    • PTT and PT/INR within institutional normal limits
  • Patients must sign informed consent for study participation

Exclusion Criteria

  • Evidence of distant metastasis of thyroid carcinoma
  • Recurrent thyroid cancer
  • Prior thyroid surgery or surgery to the neck.
  • Patients with diagnosed coagulation disorders
  • Prior irradiation to the neck area
  • Prior chemotherapy for the current diagnosis
  • Patients on therapeutic warfarin
  • Patients with psychological or cognitive issues that, in the opinion of the investigator, will make them unable to adequately report pain levels
  • Patients in an immune deficient state

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
For subjects in the placebo group, saline was drawn into the applicator and aerosolized in a similar fashion; it was allowed to remain in the wound during closure.
Drug: EVICEL
EVICEL
Experimental: Evicel
For subjects in the treatment group, Evicel was applied in the usual manner by study personnel, with 5mL of each component drawn into a two-barrel syringe device and aerosolized using a pedal-controlled inert gas supply.
Drug: EVICEL
EVICEL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 90 days
First 8 hours output (mL), Total output (mL), Drain time (hours), Hospital stay (hours), AEs
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

Ethicon, Inc.

Investigators

  • Principal Investigator: Joshua Hornig, MD, Medical University of South Carolina
  • Study Director: Shaun A Nguyen, M.D.,CPI, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

October 21, 2010

First Submitted That Met QC Criteria

October 21, 2010

First Posted (Estimate)

October 22, 2010

Study Record Updates

Last Update Posted (Actual)

February 5, 2019

Last Update Submitted That Met QC Criteria

January 14, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVICEL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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