ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries

Burns Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02380612
• Other study ID #: CTP001-6
• Status: Completed
• Phase: N/A
• Start date: January 26, 2015
• Est. completion date: February 1, 2017

Study information

• Verified date: February 2021
• Source: Avita Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 1, 2017
• Est. primary completion date: January 21, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Burns

Intervention

Device:
• ReCell Treatment

Procedure:
• Skin Graft

Locations

Country	Name	City	State
United States	North Carolina Jaycee Burn Center	Chapel Hill	North Carolina
United States	USAISR - US Army Institute of Surgical Research	Fort Sam Houston	Texas
United States	University of Tennessee Health Science Center	Memphis	Tennessee
United States	Arizona Burn Center at Maricopa Medical Center	Phoenix	Arizona
United States	Tampa General Hospital	Tampa	Florida
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Avita Medical	Advanced Clinical Research Services, LLC, MedDRA Assistance Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)	Complete wound closure is defined as skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a qualified clinician blinded to treatment assignment. The incidence of complete wound closure is hypothesized to be non-inferior for RECELL-treated areas as compared to control areas.	Prior to or at 8 weeks
Primary	Actual Expansion Ratios (Treatment Area to Donor Site Area, Inclusive of Donor Skin Needed for Secondary Treatments)	For this second co-primary endpoint, it is hypothesized that the expansion ratio associated with the RECELL treatment area will be superior to that of the control, i.e. less donor skin will be required for RECELL-treated areas compared with the control areas.	Prior to or at 8 weeks
Secondary	Observer Overall Patient and Observer Scar Assessment Scale ( POSAS) Opinion Score	The observer component of the Patient and Observer Scar Assessment Scale (POSAS) questionnaire required the blinded evaluator to provide an overall opinion of the treatment area compared to normal skin, scored from 1 (normal skin) to 10 (worst imaginable scar).	At 24 Week
Secondary	Patient's Satisfaction/Treatment Preference		At 24 Week
Secondary	Patient Overall Patient and Observer Scar Assessment Scale (POSAS) Opinion Score	The patient component of the Patient Overall Patient and Observer Scar Assessment Scale (POSAS) questionnaire required the patient to provide an overall opinion of the treatment area compared to normal skin, scored from 1 (normal skin) to 10 (worst imaginable scar). T	Week 24