A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries
Public ClinicalTrials.gov record NCT01138917. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01138917
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 101 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 21, 2010 (Actual)
- Primary completion
- Aug 29, 2014 (Actual)
- Completion
- Aug 26, 2015 (Actual)
- Last update posted
- May 13, 2019
2010 – 2015
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Burn Center at Maricopa Integrated Health Systems | Phoenix | Arizona | 85008 | — |
| University of California Davis Regional Burn Center | Sacramento | California | 95817 | — |
| The Burn Center at Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Shands Burn Center at University of Florida | Gainesville | Florida | 32610 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Indiana University - Richard M. Fairbanks Burn Center at Wishard Memorial Hospital | Indianapolis | Indiana | 46202 | — |
| NC Jaycee Burn Center at University of NC at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| University of Tennessee Medical Center | Memphis | Tennessee | 38163 | — |
| USAISR | Fort Sam Houston | Texas | 78234 | — |
| Texas Tech University Health Sciences Center | Lubbock | Texas | 79430 | — |
| Virginia Commonwealth University Health System- Evans Haynes Burn Center | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01138917, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 13, 2019 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01138917 live on ClinicalTrials.gov.