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Arista for ALT Donor Sites to Reduce Drain Output

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ClinicalTrials.gov Identifier: NCT02477774
Recruitment Status : Recruiting
First Posted : June 23, 2015
Last Update Posted : February 24, 2020
Sponsor:
Collaborator:
Davol Inc.
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:

This is a single-blinded multi-institutional 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 in anterolateral thigh (ALT) free flap donor sites. Increased drainage from donor sites 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 free flap donor sites may bear significant potential benefit.

Specific Aim 1: The main hypothesis of the study is that the use of Arista in anterolateral thigh (ALT) free flap donor sites prior to closure will reduce postoperative drain outputs and time to drain removal compared to ALT donor sites closed without Arista.

Specific Aim 2: This study will also evaluate the secondary hypotheses that Arista will reduce postoperative ALT donor site seromas and patient hospital length of stay.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Multi-Institutional Randomized Controlled Trial Evaluating Use of Arista Absorbable Surgical Hemostatic Powder in Anterolateral Thigh Donor Sites
Study Start Date : July 2016
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Arm Intervention/treatment
Experimental: Arista
Arista to ALT donor site
Device: ARISTA
According to the manufacturer, Arista uses Microporous Polysaccharide Hemospheres (MPH) technology to catalyze the clotting cascade and effectively dehydrate tissue to initiate hemostasis in broad areas. Major advantages of Arista are that it has been shown to be safe and effective across multiple surgical disciplines, is completely absorbed in 24-48 hours, and contains no human or animal components

No Intervention: Control
No Arista to ALT donor site



Primary Outcome Measures :
  1. total drain output [ Time Frame: 1-14 days after Surgery ]
    The primary outcome analyzed in this study will be total drain output (mL) in an effort to determine if the addition of Arista to the wound bed decreases overall wound drainage and drain output.

  2. Development of ALT donor site seroma. [ Time Frame: 30 days postoperative ]
    ALT donor site will be evaluated for seroma

  3. Timing to Drain Removal [ Time Frame: 30 days postoperative ]
    Given that drain output influences time of drain removal, assessment will be made to determine if timing of drain removal differs between groups.


Secondary Outcome Measures :
  1. Hospital Length of Stay [ Time Frame: 30 days postoperative ]
    Will eval hospital length of stay for both groups



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients undergoing ALT free tissue transfer for head and neck reconstruction
  • 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 entry.

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): NCT02477774


Locations
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United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94115
Contact: Rahul Seth, MD       Rahul.seth@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Davol Inc.
Investigators
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Principal Investigator: Rahul Seth, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02477774    
Other Study ID Numbers: ALT Arista
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Keywords provided by University of California, San Francisco:
Anterolateral Thigh
Additional relevant MeSH terms:
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Seroma
Inflammation
Pathologic Processes