A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries
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.
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Burns
Intervention
ReCell and Split-thickness skin graft
Location
Wake Forest University Health Sciences
Winston-Salem
North Carolina
United States
27157
Status
Recruiting
Source
Avita Medical Americas, LLC
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01138917
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:13:08-0400
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Medical and Biotech [MESH] Definitions
Skin, Artificial
Synthetic material used for the treatment of burns and other conditions involving large-scale loss of skin. It often consists of an outer (epidermal) layer of silicone and an inner (dermal) layer of collagen and chondroitin 6-sulfate. The dermal layer elicits new growth and vascular invasion and the outer layer is later removed and replaced by a graft.
Skinfold Thickness
The measurement of subcutaneous fat located directly beneath the skin by grasping a fold of skin and subcutaneous fat between the thumb and forefinger and pulling it away from the underlying muscle tissue. The thickness of the double layer of skin and subcutaneous tissue is then read with a caliper. The five most frequently measured sites are the upper arm, below the scapula, above the hip bone, the abdomen, and the thigh. Its application is the determination of relative fatness, of changes in physical conditioning programs, and of the percentage of body fat in desirable body weight. (From McArdle, et al., Exercise Physiology, 2d ed, p496-8)
Burns
Injuries to tissues caused by contact with heat, steam, chemicals (BURNS, CHEMICAL), electricity (BURNS, ELECTRIC), or the like.
Nuchal Translucency Measurement
A prenatal ultrasonic measurement of the thickness or translucent area below the SKIN in the back of the fetal NECK, or nape of the neck, during the first 11-14 weeks of gestation (PREGNANCY TRIMESTER, FIRST). Abnormal thickness or nuchal translucent measurements resulting from fluid collection, is associated with increased risks of CHROMOSOME ABNORMALITIES. (Nicolaides et al., 1992)
Host Vs Graft Reaction
The immune responses of a host to a graft. A specific response is GRAFT REJECTION.
