Randomized Controlled Trial Evaluating Use of Arista Absorbable Surgical Hemostatic Powder in Total Thyroidectomy With and Without Neck Dissections

This is a single-blinded randomized controlled trial to evaluate the effectiveness of Arista hemostatic matrix powder in reducing drainage output after total thyroidectomy with and without lateral neck dissections. Increased drainage in total thyroidectomy and neck dissection wound beds can lead to seroma formation with possible secondary infection, delayed hospital discharge, and additional home care needs for drain care. Arista is an inert plant based absorbable surgical hemostatic powder that can be easily applied to broad surgical fields to reduce bleeding and seroma rates. Therefore, its application to thyroidectomy and neck dissection wound beds may bear significant potential benefit.

Specific Aim 1: The main hypothesis of the study is that the use of Arista in total thyroidectomy with and without lateral neck dissections prior to closure will reduce postoperative drain outputs and time to drain removal compared to total thyroidectomy with and without lateral neck dissection closed without Arista.

Specific Aim 2: This study will also evaluate the secondary hypotheses that Arista will reduce postoperative hematoma and seroma rates and hospital length of stay in total thyroidectomies with and without lateral neck dissections.

INTRODUCTION

Total thyroidectomy is an increasingly common procedure performed where the entire thyroid gland is removed for either benign or malignant disease. Common indications include multinodular goiter, Graves disease, and thyroid carcinoma. Between 2006 and 2011 the number of total thyroidectomies performed in the United States increased by 12% per year, from 45,558 to 72,344 according the to the American Cancer Society. In 2011 48,000 total thyroidectomies were performed for malignant disease which often requires additional lateral neck dissection.