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

NCT01226914 | Completed Results

• 1 other identifier: EVICEL
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

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

Keywords

EVICEL, Fibrin Sealant, Thyroidectomy

Outcome Measures

Primary Outcomes (1)

• 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

  90 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Drug: EVICEL

Evicel

EXPERIMENTAL

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.

Drug: EVICEL

Interventions

EVICEL DRUG

EVICEL

Evicel; Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Ethicon, Inc.: collaborator

MeSH Terms

Conditions

Thyroid Neoplasms; Goiter

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Results Point of Contact

• Title: Shaun A. Nguyen, MD, FAPCR
• Organization: Medical University of South Carolina - Department of Otolaryngology - Head and Neck Surgery

nguyensh@musc.edu

8437921356

Study Officials

• Joshua Hornig, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Shaun A Nguyen, M.D.,CPI

  Medical University of South Carolina

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Director of Clinical Research

Model Details: prospective randomized placebo-controlled double-blind trial.

Study Record Dates

• First Submitted: October 21, 2010
• First Posted: October 22, 2010
• Study Start: June 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: February 5, 2019
• Results First Posted: February 5, 2019

Record last verified: 2019-01