Overview

This trial is active, not recruiting.

Condition burns
Treatments recell treatment, skin graft
Sponsor Avita Medical
Collaborator MedDRA Assistance Inc
Start date January 2015
End date April 2016
Trial size 30 participants
Trial identifier NCT02380612, CTP001-6

Summary

This is a randomized, within-subject controlled study to compare the clinical performance of the ReCell device when used as an adjunct to meshed skin graft in subjects requiring skin grafts for closure of burn injuries. Co-primary effectiveness endpoints include: (1) confirmed treatment area closure (i.e., healing) prior to or at 8 weeks as assessed by a blinded evaluator, and (2) a comparison of the actual expansion ratio, computed as the ratio of measured treated area to the measured donor site area, achieved for the ReCell-treated and control treatment areas. Safety will be evaluated in terms of long-term durability, scar outcomes and treatment-related adverse events.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B
recell treatment
skin graft
(Experimental)
All subjects will receive both ReCell and skin graft. Each patient serves as their own control. Their study treatment area (burn injury) will be divided into Area A and Area B. Investigational treatment will be randomly allocated to either Area A or Area B
recell treatment
skin graft

Primary Outcomes

Measure
Confirmed Treatment Area Closure
time frame: Prior to or at 8 weeks
The actual expansion ratios (treatment area to donor site area, inclusive of donor skin needed for secondary treatments) will be calculated separately for the ReCell and control treatments.
time frame: Prior to or at 8 weeks

Secondary Outcomes

Measure
POSAS
time frame: At 24 Week
Patient Preference (between ReCell versus control)
time frame: At 24 Week

Eligibility Criteria

Male or female participants at least 5 years old.

Inclusion Criteria: 1. The subject requires skin grafting as a result of an acute thermal burn injury (i.e. injuries caused by exposure of the skin to fire/flames, excessive heat, hot steam or water). 2. The area of total burn injury is 5-50% TBSA inclusive. 3. Two areas requiring skin grafting, each at least 300cm2 (or 600cm2 contiguous), excluding hand/face and joints. 4. The subject is at least 5 years of age. 5. The subject (or family, for those under 18 years of age) is willing and able to complete all followup evaluations required by the study protocol. 6. The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary. 7. The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study. 8. The subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent. Exclusion Criteria: 1. The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances. 2. The subject is unable to follow the protocol. 3. The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives. 4. The subject has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution. 5. Life expectancy is less than 1 year.

Additional Information

Official title Demonstration of the Safety and Effectiveness of ReCell® Combined With Meshed Skin Graft for Reduction of Donor Area in the Treatment of Acute Burn Injuries
Principal investigator James H Holmes, IV, MD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Avita Medical.