A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries
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|ClinicalTrials.gov Identifier: NCT01138917|
Recruitment Status : Completed
First Posted : June 8, 2010
Results First Posted : May 13, 2019
Last Update Posted : May 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Burns||Device: ReCell and Split-thickness skin graft||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries|
|Actual Study Start Date :||May 21, 2010|
|Actual Primary Completion Date :||August 29, 2014|
|Actual Study Completion Date :||August 26, 2015|
Experimental: all participants
All participants will receive both ReCell and split-thickness skin graft
Device: ReCell and Split-thickness skin graft
The surgeon will be required to select two similar non-contiguous injury areas with both areas being at least 100cm2 and second degree depth/severity. One area will be treated using ReCell and the second using Split-thickness Skin Graft.
- Incidence of RECELL-treated Area Closure Compared to Control at 4 Weeks (Non-inferiority) [ Time Frame: 4 weeks ]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 >=95% epithelialized.
- Incidence of RECELL Donor Site Healing Compared to Control at 1 Week (Superiority) [ Time Frame: 1 week ]Donor site healing will be considered as complete (100%) wound closure if the following criteria were met: an ability to separate the dressing from the wound bed with visible presence over the entirety of the wound of dry, opalescent-pink external surface representing the newly formed outer cornfield layer of the epidermis.
- Percent of Epithelialization at Each Visit Through Week 16 [ Time Frame: Each visit through Week 16 ]The percent epithelialization of the RECELL and Control treated sites will be assessed using standardized planimetry/tracing procedures. The tracings were uploaded to a Central Reading Facility for calculation of percent epithelialization using a computerized measurement technique.
- Wound Closure at Week 2 (Based on Investigators Assessment) [ Time Frame: Week 2 ]The proportion of recipient sites achieving wound closure at Week 2 was evaluated using the Investigators assessment of wound healing.
- Mean Pain and Appearance Scores at RECELL and Control Recipient Sites (Subject Assessment) [ Time Frame: Pain (Weeks 1-16) and Appearance (Weeks 16-52) ]
Subject assessment of pain at the RECELL and Control recipient sites was performed at all study follow-up visits up to Week 16.
Subjects also assessed the satisfaction with the appearance of the treatment sites at the Week 16, 24, and 52 study follow-up visits. The subject assessments were performed using VAS (visual analogue scale) style questionnaires.
Pain VAS 0-100 where 0=non-existent pain and 100=severe pain. Appearance VAS 0-100 where 0=terrible and 100=exceptional
- Mean Pain and Appearance Scores at Donor Sites (Subject Assessment) [ Time Frame: Pain (Weeks 1-16) and Appearance (Weeks 16-52) ]
Subject assessment of pain at the RECELL and Control donor sites was performed at all study follow-up visits up to Week 16.
Subjects also assessed the satisfaction with the appearance of the donor sites at the Week 16, 24, and 52 study follow-up visits. The subject assessments were performed using VAS (visual analogue scale) style questionnaires.
Pain VAS 0-100 where 0=non-existent pain and 100=severe pain. Appearance VAS 0-100 where 0=terrible and 100=exceptional.
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): NCT01138917
|United States, Arizona|
|Arizona Burn Center at Maricopa Integrated Health Systems|
|Phoenix, Arizona, United States, 85008|
|United States, California|
|University of California Davis Regional Burn Center|
|Sacramento, California, United States, 95817|
|United States, District of Columbia|
|The Burn Center at Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|United States, Florida|
|Shands Burn Center at University of Florida|
|Gainesville, Florida, United States, 32610|
|Tampa General Hospital|
|Tampa, Florida, United States, 33606|
|United States, Indiana|
|Indiana University - Richard M. Fairbanks Burn Center at Wishard Memorial Hospital|
|Indianapolis, Indiana, United States, 46202|
|United States, North Carolina|
|NC Jaycee Burn Center at University of NC at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Wake Forest University Health Sciences|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Tennessee|
|University of Tennessee Medical Center|
|Memphis, Tennessee, United States, 38163|
|United States, Texas|
|Fort Sam Houston, Texas, United States, 78234|
|Texas Tech University Health Sciences Center|
|Lubbock, Texas, United States, 79430|
|United States, Virginia|
|Virginia Commonwealth University Health System- Evans Haynes Burn Center|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||James H Holmes, MD||Wake Forest University Health Sciences|