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Trial Evaluating Use of Arista in Total Thyroidectomy

NCT02568085 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-08-14

No results posted yet for this study

Summary

This is a single-blinded randomized controlled trial to evaluate the effectiveness of Arista hemostatic matrix powder (Arista® AH, C. R. Bard, Inc. Davol, Warwick, RI) 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.

Conditions

  • Thyroidectomy
  • Seroma

Interventions

DEVICE

Arista

Arista™ AH is a medical device intended for application to surgical wound sites as an absorbable hemostat. The device is a fine, dry, sterilized white powder that is biocompatible, non-pyrogenic, and is typically absorbed within 24 to 48 hours.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2017-03-31
Completion
2017-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02568085 on ClinicalTrials.gov