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

AVITA Medical

Status: Completed

Conditions: Burns

Treatments: Device: ReCell and Split-thickness skin graft

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT01138917

CTP001-5

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The subject requires primary skin grafting as a result of an acute thermal burn injury
• The area of the burn injury is at least 200cm2 (1% TBSA in adults) if a contiguous wound, or at least 100cm2 for each of 2 noon-contiguous wounds
• The area of total burn injury is 1-20% TBSA
• The burn injured area can be divided into two treatment areas ( control and treatment) with 100-320cm2 area for each treatment type
• The study treatment area is a second degree burn injury
• The subject is between 18-65 years of age
• The subject is willing to complete all follow-up evaluations required by the study protocol
• The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary
• The subject agrees to abstain from enrollment in any other clinical trial for the duration of the study
• The subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent
• The subject is able and willing to follow the protocol requirements

Exclusion criteria

• The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances
• The total subject burn injury is less than 1% or more than 20% TBSA
• The subject has a microbiologically proven pre-existing local or systemic bacterial infection
• The subject has been receiving a systemic antibiotic for more than 48 hours prior to grafting
• The subject is known to have a pre-existing condition that may interfere with wound healing ( e.g. malignancy, diabetes, or autoimmune disease)
• The subject is unable to follow the protocol
• The subject is taking medication known to have an effect on wound healing or skin pigmentation ( e.g. systemic corticosteroids, retinoids, etc)
• The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives
• The subject has a known hypersensitivity to Trypsin or Compound sodium Lactate for Irrigation (Hartmann's) solution

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 1 patient group

all participants

Experimental group

Description:

All participants will receive both ReCell and split-thickness skin graft

Treatment:

Device: ReCell and Split-thickness skin graft