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

Primary Purpose

Burns

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ReCell Treatment
Skin Graft
Sponsored by
Avita Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring Second Degree Burn Injuries

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona Burn Center at Maricopa Medical Center
  • MedStar Washington Hospital Center
  • Tampa General Hospital
  • North Carolina Jaycee Burn Center
  • Wake Forest Baptist Medical Center
  • University of Tennessee Health Science Center
  • USAISR - US Army Institute of Surgical Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All Participants (within patient control)

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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).
Patient's Satisfaction/Treatment Preference
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

Full Information

First Posted
February 17, 2015
Last Updated
February 22, 2021
Sponsor
Avita Medical
Collaborators
MedDRA Assistance Inc, Advanced Clinical Research Services, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02380612
Brief Title
ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 26, 2015 (Actual)
Primary Completion Date
January 21, 2016 (Actual)
Study Completion Date
February 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avita Medical
Collaborators
MedDRA Assistance Inc, Advanced Clinical Research Services, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Second Degree Burn Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
The participant and blinded evaluator will be not be told which treatment area received which treatment (RECELL or Control).
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All Participants (within patient control)
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
ReCell Treatment
Intervention Type
Procedure
Intervention Name(s)
Skin Graft
Primary Outcome Measure Information:
Title
Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)
Description
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.
Time Frame
Prior to or at 8 weeks
Title
Actual Expansion Ratios (Treatment Area to Donor Site Area, Inclusive of Donor Skin Needed for Secondary Treatments)
Description
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.
Time Frame
Prior to or at 8 weeks
Secondary Outcome Measure Information:
Title
Observer Overall Patient and Observer Scar Assessment Scale ( POSAS) Opinion Score
Description
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).
Time Frame
At 24 Week
Title
Patient's Satisfaction/Treatment Preference
Time Frame
At 24 Week
Title
Patient Overall Patient and Observer Scar Assessment Scale (POSAS) Opinion Score
Description
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
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James H Holmes, IV, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Burn Center at Maricopa Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
North Carolina Jaycee Burn Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103-3409
Country
United States
Facility Name
USAISR - US Army Institute of Surgical Research
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States

12. IPD Sharing Statement

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

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