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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Ethicon, Inc.
Information provided by (Responsible Party):
Shaun A. Nguyen, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01226914
First received: October 21, 2010
Last updated: May 20, 2013
Last verified: May 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 120
Study Start Date: June 2010
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EVICEL Drug: EVICEL
EVICEL

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 21, 2010
Last Updated: May 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
EVICEL, Fibrin Sealant, Thyroidectomy

Additional relevant MeSH terms:
Neoplasms
Thyroid Neoplasms
Goiter
Postoperative Complications
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Pathologic Processes
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014