Advertisement

Topics

A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries

2014-08-27 03:13:08 | BioPortfolio

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)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:08-0400

Clinical Trials [1632 Associated Clinical Trials listed on BioPortfolio]

Glyaderm + Split Thickness Skin Graft Versus Split Thickness Skin Graft Alone in Full Thickness Skin Defects

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...

Epidermal Coverage of Traumatic Wound Injuries Via Use of Autologous Spray Skin Applied Over Bilayered Wound Matrix

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...

Prospective Evaluation of the ReCell® Autologous Cell Harvesting Device For Specific Compassionate Use Cases

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...

PubMed Articles [6092 Associated PubMed Articles listed on BioPortfolio]

Topical Aloe Vera Gel for Accelerated Wound Healing of Split-Thickness Skin Graft Donor Sites: A Double-Blind, Randomized, Controlled Trial and Systematic Review."

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...

Deepening Fornix Technique Using Central Split-Medium Thickness Skin Graft to Treat Contracted Anophthalmic Sockets.

The aim of thhis study was to present the outcomes of postauricular split-medium thickness skin graft (SMTSG) to treat anophthalmic sockets with contracted fornices.

Efficacy of a gel containing polihexanide and betaine in deep partial and full thickness burns requiring split-thickness skin grafts: A non-comparative clinical study.

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...

New onset squamous cell carcinoma in previous split-thickness skin graft donor site.

Marjolin' s ulcer, an aggressive ulcerating squamous cell carcinoma, is a well-known phenomenon that occurs in chronically inflamed or scarred tissue; however, squamous cell carcinoma arising in the a...

Medical and Biotech [MESH] Definitions

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.

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)

Injuries to tissues caused by contact with heat, steam, chemicals (BURNS, CHEMICAL), electricity (BURNS, ELECTRIC), or the like.

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)

The immune responses of a host to a graft. A specific response is GRAFT REJECTION.

More From BioPortfolio on "A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Wound management
Anything that breaks the skin is a wound because when the skin is broken, there's a risk of germs getting into the body and causing an infection. Follow and track Wound Care News on BioPortfolio: Wound Car...

Dermatology
Acne Dermatology Eczema Psoriasis Wound Care Dermatology is the medical specialty concerned with the diagnosis and treatment of skin disorders (Oxford Medical Dictionary). As well as studying how the skin works, dermatology covers...


Searches Linking to this Trial