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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Burns
ReCell and Split-thickness skin graft
Wake Forest University Health Sciences
Winston-Salem
North Carolina
United States
27157
Recruiting
Avita Medical Americas, LLC
Published on BioPortfolio: 2014-08-27T03:13:08-0400
The application of Glyaderm for skin restoration intends to provide a more stable wound closure with enhanced pliability and function of the skin and a more favourable scar. The dermal sub...
The purpose of this investigation is to evaluate the safety, tolerability, preliminary and long-term effectiveness of utilizing the ReCell Autologous Cell Harvesting Device (ReCell) combin...
Dermal Substitute and Topical Negative Pressure in Burns
The purpose of this study is to determine whether a treatment of full thickness wounds by the dermal substitute Matriderm, split skin graft and VAC treatment will improve scar quality, dem...
This is a prospective uncontrolled observational study to evaluate clinical outcomes following use of the ReCell Autologous Cell Harvesting Device (ReCell) as an adjunct for closure (re-ep...
Evaluation of Opticell Ag on Split-Thickness Skin Graft Donor Sites in Adult Subjects
The purpose of this single center, prospective case series is to evaluate the effective management of split-thickness skin graft donor site wounds using Opticell Ag (Chitosan-based dressin...
Aloe vera has been used to treat wounds since ancient times. However, the efficacy of Aloe vera for burns and split-thickness skin graft (STSG) donor sites are inconclusive.
Split-thickness skin grafting: early outcomes of a clinical trial using different graft thickness.
In clinical practice, split-thickness skin graft (STSG) transplantation remains the gold standard for covering large skin defects. Currently, there is no consensus on the optimal thickness of skin gra...
Managing cutaneous substance loss after debridement is challenging, especially if it is secondary to necrotizing soft tissue infection, such as necrotizing fasciitis and Fournier gangrene. After skin ...
Despite overall advances in burn therapy, wound infection remains one of the leading causes of morbidity and mortality in patients with severe burn injuries. This prospective, multicenter, non-compara...
Full-thickness skin grafts for lower leg defects coverage: Interest of postoperative immobilization.
Full-thickness skin graft is an effective reconstruction method after excision of skin lesions on the lower limb that are not amenable to primary closure. The randomness of graft take is the major dra...
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.