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NCT01138917 · ClinicalTrials.gov registry record · NA
A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries
A NA study of Burns, sponsored by Avita Medical.
- Completed
- Registry status
- NA
- Development phase
- 101
- Enrollment target
- 12
- Study locations
NCT01138917: Completed NA study of Burns, sponsored by Avita Medical.
NCT01138917 is a NA study of Burns that has completed, run by Avita Medical. The registered enrollment target is 101 participants, above the 80-participant average among 36 other Burns trials with a reported enrollment target (26% higher). The trial reports 12 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01138917, a NA study of Burns, has completed, sponsored by Avita Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 101 participants
- Enrollment target
- 12
- Study locations
Study Summary
This is a randomized, within-patient controlled study to compare the clinical performance of the ReCell Device with that of Split-thickness Meshed Skin Grafts for the treatment of second degree burns. The hypothesis to be supported are: 1) non-inferiority with the primary efficacy endpoint defined as recipient site wound closure at week 4 follow-up visit of the ReCell-treated area as compared to that of the STMSG-treated area, and 2)superiority in the healing of the ReCell donor site as compared to the STMSG donor site at week 1.
Primary Outcome
Recipient site wound closure for both ReCell and STMSG will be defined as the presence of \>=95% epithelialization with contiguous layer of viable epithelium without the need for secondary surgical intervention. Factors considered during the assessment included color, presence of granulation tissue, and whether or not the entire wound is covered with a contiguous layer of viable epithelium. Using this definition, some small degree of punctate blistering was acceptable as long as the wound was \>
Conditions Studied
Interventions
- DEVICE ReCell and Split-thickness skin graft
Study Locations (12)
Florida
- Shands Burn Center at University of Florida - Gainesville
- Tampa General Hospital - Tampa
North Carolina
- NC Jaycee Burn Center at University of NC at Chapel Hill - Chapel Hill
- Wake Forest University Health Sciences - Winston-Salem
Texas
- USAISR - Fort Sam Houston
- Texas Tech University Health Sciences Center - Lubbock
Arizona
- Arizona Burn Center at Maricopa Integrated Health Systems - Phoenix
California
- University of California Davis Regional Burn Center - Sacramento
District of Columbia
- The Burn Center at Washington Hospital Center - Washington D.C.
Indiana
- Indiana University - Richard M. Fairbanks Burn Center at Wishard Memorial Hospital - Indianapolis
Tennessee
- University of Tennessee Medical Center - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2010-05-21 |
| Est. Completion | 2015-08-26 |
| Phase | NA |
What the finished NCT01138917 record still lists
NCT01138917 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, above the 80-participant average among 36 other Burns trials with a reported enrollment target (26% higher).
The record links to 1 condition, with Burns appearing as the primary indexed condition, and to 1 intervention - of which ReCell and Split-thickness skin graft is the first listed.
NCT01138917 lists 12 locations in 9 states (Florida, North Carolina, Texas).
Frequently Asked Questions
What is clinical trial NCT01138917 about?
NCT01138917 is a clinical study titled "A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries". This is a randomized, within-patient controlled study to compare the clinical performance of the ReCell Device with that of Split-thickness Meshed Skin Grafts for the treatment of second degree burns. The hypothesis to be supported are: 1) non-inferiority with the primary efficacy endpoint defined a...
What is the current status of trial NCT01138917?
This trial is currently completed. It is a NA study. The enrollment target is 101 participants. The study started on 2010-05-21. Estimated completion is 2015-08-26.
What conditions does trial NCT01138917 study?
This clinical trial studies the following conditions: Burns.
What interventions are being tested in trial NCT01138917?
The interventions under investigation include: ReCell and Split-thickness skin graft (DEVICE).
Who is sponsoring clinical trial NCT01138917?
This trial is sponsored by Avita Medical, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01138917 being conducted?
This trial has 12 study locations across Arizona, California, District of Columbia, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Burns
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01138917's enrollment target sits among peer trials
101 8th of 36 higher than 29 of 36 other Burns trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Burns trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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