Trial Evaluating Use of Arista in Total Thyroidectomy
Randomized Controlled Trial Evaluating Use of Arista Absorbable Surgical Hemostatic Powder in Total Thyroidectomy With and Without Neck Dissections
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
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Started Mar 2016
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2015
CompletedFirst Posted
Study publicly available on registry
October 5, 2015
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedAugust 14, 2019
August 1, 2019
1 year
September 29, 2015
August 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Drain output
Measured output from closed suction drain in ml. This will be recorded every 12 hrs until drain is removed.
1-14 days after Surgery
Secondary Outcomes (1)
Seroma (Rate of clinically relevant seroma complications)
1-14 days after surgery
Study Arms (4)
1
EXPERIMENTALthyroidectomy + Arista
2
NO INTERVENTIONThyroidectomy
3
EXPERIMENTALThyroidectomy with neck + Arista
4
NO INTERVENTIONThyroidectomy with neck
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCSF Mission Bay
San Francisco, California, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2015
First Posted
October 5, 2015
Study Start
March 1, 2016
Primary Completion
March 1, 2017
Study Completion
June 1, 2017
Last Updated
August 14, 2019
Record last verified: 2019-08