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Trial Evaluating Use of Arista in Total Thyroidectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02568085
Recruitment Status : Withdrawn
First Posted : October 5, 2015
Last Update Posted : August 14, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease Intervention/treatment Phase
Thyroidectomy Seroma Device: Arista Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Randomized Controlled Trial Evaluating Use of Arista Absorbable Surgical Hemostatic Powder in Total Thyroidectomy With and Without Neck Dissections
Study Start Date : March 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: 1
thyroidectomy + Arista
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.

No Intervention: 2
Thyroidectomy
Experimental: 3
Thyroidectomy with neck + Arista
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.

No Intervention: 4
Thyroidectomy with neck



Primary Outcome Measures :
  1. Drain output [ Time Frame: 1-14 days after Surgery ]
    Measured output from closed suction drain in ml. This will be recorded every 12 hrs until drain is removed.


Secondary Outcome Measures :
  1. Seroma (Rate of clinically relevant seroma complications) [ Time Frame: 1-14 days after surgery ]
    The rate of clinically relevant seroma complications will be evaluated for each group. Relevant seromas are those requiring intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing Total Thyroidectomy with or without lateral neck dissection
  • Patient must be 18 years of age or older.
  • The patient must have capacity to be able to sign a study-specific informed consent prior to study

Exclusion Criteria:

  • Pregnancy (for female patients).
  • Patients who will require anticoagulant medications other than routine DVT prophylaxis within 8 days postoperatively.
  • Presence of clotting or bleeding disorder.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568085


Locations
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United States, California
UCSF Mission Bay
San Francisco, California, United States
Sponsors and Collaborators
University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02568085    
Other Study ID Numbers: Arista for Thyroids
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Seroma
Inflammation
Pathologic Processes