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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01226914
First Posted: October 22, 2010
Last Update Posted: August 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ethicon, Inc.
Information provided by (Responsible Party):
Shaun A. Nguyen, Medical University of South Carolina
  Purpose

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.

Condition Intervention
Thyroid Neoplasm Goiter Drug: EVICEL

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official 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

Resource links provided by NLM:


Further study details as provided by Shaun A. Nguyen, Medical University of South Carolina:

Primary Outcome Measures:
  • 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: one year ]

Secondary Outcome Measures:
  • To compare the length of time to drain removal between Arm A and Arm B. [ Time Frame: one year ]

Estimated Enrollment: 120
Study Start Date: June 2010
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EVICEL Drug: EVICEL
EVICEL

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01226914


Sponsors and Collaborators
Medical University of South Carolina
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
  More Information

Responsible Party: Shaun A. Nguyen, Associate Professor - Director of Clinical Research, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01226914     History of Changes
Other Study ID Numbers: EVICEL
First Submitted: October 21, 2010
First Posted: October 22, 2010
Last Update Posted: August 20, 2014
Last Verified: August 2014

Keywords provided by Shaun A. Nguyen, Medical University of South Carolina:
EVICEL, Fibrin Sealant, Thyroidectomy

Additional relevant MeSH terms:
Thyroid Neoplasms
Postoperative Complications
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Pathologic Processes
Fibrin Tissue Adhesive
Hemostatics
Coagulants