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

Goiter Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01226914
• Other study ID #: EVICEL
• Status: Completed
• Phase: N/A
• Start date: June 2010
• Est. completion date: July 2014

Study information

• Verified date: January 2019
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Goiter
• Postoperative Complications
• Thyroid Neoplasm
• Thyroid Neoplasms

Intervention

Drug:
• EVICEL
EVICEL

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	Ethicon, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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