Arista for ALT Donor Sites to Reduce Drain Output

NCT02477774 | Completed Results

• 1 other identifier: ALT Arista
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Seroma

Keywords

Anterolateral Thigh

Outcome Measures

Primary Outcomes (3)

• Total Drain Output

  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.

  1-14 days after Surgery

• Number of Participants With the Development of ALT Donor Site Seroma

  ALT donor site will be evaluated for seroma

  30 days postoperative

• Timing to Drain Removal

  Given that drain output influences time of drain removal, assessment will be made to determine if timing of drain removal differs between groups.

  30 days postoperative

Secondary Outcomes (1)

• Hospital Length of Stay

  30 days postoperative

Study Arms (2)

Arista

EXPERIMENTAL

Arista to ALT donor site

Device: ARISTA

Control

NO INTERVENTION

No Arista to ALT donor site

Interventions

ARISTA DEVICE

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

Arista

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Davol Inc.: collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Seroma

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Rahul Seth, MD
• Organization: University of California, San Francisco

Rahul.Seth@ucsf.edu

415-353-9500

Study Officials

• Rahul Seth, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

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: June 18, 2015
• First Posted: June 23, 2015
• Study Start: July 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 22, 2022
• Results First Posted: September 22, 2022

Record last verified: 2022-08

Locations

US (1)