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

Medical University of South Carolina55 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Thyroid Neoplasm Goiter

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 90 days