A 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.

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Key information

Conditions

Thyroid Neoplasm Endocrine Gland Neoplasms Endocrine System Diseases Goiter Head and Neck Neoplasms Neoplasms Neoplasms by Site Thyroid Diseases Thyroid Neoplasms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EVICEL

Drug

EVICEL

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

Ethicon, Inc.

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2014
First posted: Oct 22, 2010
Registry last updated: Feb 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed