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Completed

NCT Number: NCT02380612

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

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.

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Key information

Conditions

Burns Wounds and Injuries

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Burn Center at Maricopa Medical Center, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).
  • The area of total burn injury is 5-50% TBSA inclusive.
  • Two areas requiring skin grafting, each at least 300cm2 (or 600cm2 contiguous), excluding hand/face and joints.
  • The subject is at least 5 years of age.
  • 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.
  • 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 interventional 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.

Exclusion criteria

  • The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances.
  • The subject is unable to follow the protocol.
  • 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.
  • Life expectancy is less than 1 year.

Treatment and study plan

ReCell Treatment

Device

Skin Graft

Procedure

Primary outcomes

  1. Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)

    Time frame: Prior to or at 8 weeks

    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.

  2. Actual Expansion Ratios (Treatment Area to Donor Site Area, Inclusive of Donor Skin Needed for Secondary Treatments)

    Time frame: Prior to or at 8 weeks

    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.

Secondary outcomes

  1. Observer Overall Patient and Observer Scar Assessment Scale ( POSAS) Opinion Score

    Time frame: At 24 Week

    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).

  2. Patient's Satisfaction/Treatment Preference

    Time frame: At 24 Week

  3. Patient Overall Patient and Observer Scar Assessment Scale (POSAS) Opinion Score

    Time frame: Week 24

    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

Sponsors and collaborators

Lead sponsor

Avita Medical

Industry

Collaborators

  • Advanced Clinical Research Services, LLC
  • MedDRA Assistance Inc

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Mar 5, 2015
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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