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

Primary Purpose

Thyroid Neoplasm, Goiter

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EVICEL
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Thyroid Neoplasm focused on measuring EVICEL, Fibrin Sealant, Thyroidectomy

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo

    Evicel

    Arm Description

    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.

    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.

    Outcomes

    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).
    First 8 hours output (mL), Total output (mL), Drain time (hours), Hospital stay (hours), AEs

    Secondary Outcome Measures

    Full Information

    First Posted
    October 21, 2010
    Last Updated
    January 14, 2019
    Sponsor
    Medical University of South Carolina
    Collaborators
    Ethicon, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01226914
    Brief Title
    A Trial Comparing Wound Drainage and Post-operative Complications With and Without the Use of EVICEL™ Fibrin Sealant in Thyroidectomy
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2010 (undefined)
    Primary Completion Date
    July 2014 (Actual)
    Study Completion Date
    July 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Medical University of South Carolina
    Collaborators
    Ethicon, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Thyroid Neoplasm, Goiter
    Keywords
    EVICEL, Fibrin Sealant, Thyroidectomy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    prospective randomized placebo-controlled double-blind trial.
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    55 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Arm Title
    Evicel
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    EVICEL
    Intervention Description
    EVICEL
    Primary Outcome Measure Information:
    Title
    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).
    Description
    First 8 hours output (mL), Total output (mL), Drain time (hours), Hospital stay (hours), AEs
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joshua Hornig, MD
    Organizational Affiliation
    Medical University of South Carolina
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Shaun A Nguyen, M.D.,CPI
    Organizational Affiliation
    Medical University of South Carolina
    Official's Role
    Study Director

    12. IPD Sharing Statement

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

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