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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborator: Ethicon, Inc.
• Treatments: Fibrin Tissue Adhesive

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