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

NCT ID: NCT01226914

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2014-07-31

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.

Conditions

Thyroid Neoplasm; Goiter

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

EVICEL

Intervention Type: DRUG

EVICEL

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.

Group Type: EXPERIMENTAL

EVICEL

Intervention Type: DRUG

EVICEL

Interventions

EVICEL

EVICEL

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon, Inc.

INDUSTRY

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Shaun A. Nguyen

Associate Professor - Director of Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joshua Hornig, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Shaun A Nguyen, M.D.,CPI

Role: STUDY_DIRECTOR

Medical University of South Carolina

Other Identifiers

EVICEL

Identifier Type: -

Identifier Source: org_study_id