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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Goiter, Thyroid Neoplasm

Intervention / Treatment
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* Drug: EVICEL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomized placebo-controlled double-blind trial.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>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<br>* EVICEL<br>|
| Experimental: Evicel<br>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<br>* EVICEL<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EVICEL, Fibrin Sealant, Thyroidectomy