N/A
N=55
Arista for ALT Donor Sites to Reduce Drain Output
Seroma
Bottom Line
View on ClinicalTrials.gov: NCT02477774 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Total Drain Output — 284; 317 ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ARISTA (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Drain Output |
284; 317 | — |
| PRIMARY Number of Participants With the Development of ALT Donor Site Seroma |
6; 4 | — |
| PRIMARY Timing to Drain Removal |
5.9; 6.5 | — |
| SECONDARY Hospital Length of Stay |
— | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02477774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.