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A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness 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 and Split-thickness 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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Arizona Burn Center at Maricopa Integrated Health Systems
  • University of California Davis Regional Burn Center
  • The Burn Center at Washington Hospital Center
  • Shands Burn Center at University of Florida
  • Tampa General Hospital
  • Indiana University - Richard M. Fairbanks Burn Center at Wishard Memorial Hospital
  • NC Jaycee Burn Center at University of NC at Chapel Hill
  • Wake Forest University Health Sciences
  • University of Tennessee Medical Center
  • USAISR
  • Texas Tech University Health Sciences Center
  • Virginia Commonwealth University Health System- Evans Haynes Burn Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

all participants

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of RECELL-treated Area Closure Compared to Control at 4 Weeks (Non-inferiority)
Recipient site wound closure for both ReCell and STMSG will be defined as the presence of >=95% epithelialization with contiguous layer of viable epithelium without the need for secondary surgical intervention. Factors considered during the assessment included color, presence of granulation tissue, and whether or not the entire wound is covered with a contiguous layer of viable epithelium. Using this definition, some small degree of punctate blistering was acceptable as long as the wound was >=95% epithelialized.
Incidence of RECELL Donor Site Healing Compared to Control at 1 Week (Superiority)
Donor site healing will be considered as complete (100%) wound closure if the following criteria were met: an ability to separate the dressing from the wound bed with visible presence over the entirety of the wound of dry, opalescent-pink external surface representing the newly formed outer cornfield layer of the epidermis.

Secondary Outcome Measures

Percent of Epithelialization at Each Visit Through Week 16
The percent epithelialization of the RECELL and Control treated sites will be assessed using standardized planimetry/tracing procedures. The tracings were uploaded to a Central Reading Facility for calculation of percent epithelialization using a computerized measurement technique.
Wound Closure at Week 2 (Based on Investigators Assessment)
The proportion of recipient sites achieving wound closure at Week 2 was evaluated using the Investigators assessment of wound healing.
Mean Pain and Appearance Scores at RECELL and Control Recipient Sites (Subject Assessment)
Subject assessment of pain at the RECELL and Control recipient sites was performed at all study follow-up visits up to Week 16. Subjects also assessed the satisfaction with the appearance of the treatment sites at the Week 16, 24, and 52 study follow-up visits. The subject assessments were performed using VAS (visual analogue scale) style questionnaires. Pain VAS 0-100 where 0=non-existent pain and 100=severe pain. Appearance VAS 0-100 where 0=terrible and 100=exceptional
Mean Pain and Appearance Scores at Donor Sites (Subject Assessment)
Subject assessment of pain at the RECELL and Control donor sites was performed at all study follow-up visits up to Week 16. Subjects also assessed the satisfaction with the appearance of the donor sites at the Week 16, 24, and 52 study follow-up visits. The subject assessments were performed using VAS (visual analogue scale) style questionnaires. Pain VAS 0-100 where 0=non-existent pain and 100=severe pain. Appearance VAS 0-100 where 0=terrible and 100=exceptional.

Full Information

First Posted
June 3, 2010
Last Updated
May 9, 2019
Sponsor
Avita Medical
Collaborators
United States Department of Defense, Royal Perth Hospital, MedDRA Assistance Inc, BioStat International, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01138917
Brief Title
A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries
Official Title
A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 21, 2010 (Actual)
Primary Completion Date
August 29, 2014 (Actual)
Study Completion Date
August 26, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avita Medical
Collaborators
United States Department of Defense, Royal Perth Hospital, MedDRA Assistance Inc, BioStat International, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

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)
Allocation
Randomized
Enrollment
101 (Actual)

8. Arms, Groups, and Interventions

Arm Title
all participants
Arm Type
Experimental
Arm Description
All participants will receive both ReCell and split-thickness skin graft
Intervention Type
Device
Intervention Name(s)
ReCell and Split-thickness skin graft
Intervention Description
The surgeon will be required to select two similar non-contiguous injury areas with both areas being at least 100cm2 and second degree depth/severity. One area will be treated using ReCell and the second using Split-thickness Skin Graft.
Primary Outcome Measure Information:
Title
Incidence of RECELL-treated Area Closure Compared to Control at 4 Weeks (Non-inferiority)
Description
Recipient site wound closure for both ReCell and STMSG will be defined as the presence of >=95% epithelialization with contiguous layer of viable epithelium without the need for secondary surgical intervention. Factors considered during the assessment included color, presence of granulation tissue, and whether or not the entire wound is covered with a contiguous layer of viable epithelium. Using this definition, some small degree of punctate blistering was acceptable as long as the wound was >=95% epithelialized.
Time Frame
4 weeks
Title
Incidence of RECELL Donor Site Healing Compared to Control at 1 Week (Superiority)
Description
Donor site healing will be considered as complete (100%) wound closure if the following criteria were met: an ability to separate the dressing from the wound bed with visible presence over the entirety of the wound of dry, opalescent-pink external surface representing the newly formed outer cornfield layer of the epidermis.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Percent of Epithelialization at Each Visit Through Week 16
Description
The percent epithelialization of the RECELL and Control treated sites will be assessed using standardized planimetry/tracing procedures. The tracings were uploaded to a Central Reading Facility for calculation of percent epithelialization using a computerized measurement technique.
Time Frame
Each visit through Week 16
Title
Wound Closure at Week 2 (Based on Investigators Assessment)
Description
The proportion of recipient sites achieving wound closure at Week 2 was evaluated using the Investigators assessment of wound healing.
Time Frame
Week 2
Title
Mean Pain and Appearance Scores at RECELL and Control Recipient Sites (Subject Assessment)
Description
Subject assessment of pain at the RECELL and Control recipient sites was performed at all study follow-up visits up to Week 16. Subjects also assessed the satisfaction with the appearance of the treatment sites at the Week 16, 24, and 52 study follow-up visits. The subject assessments were performed using VAS (visual analogue scale) style questionnaires. Pain VAS 0-100 where 0=non-existent pain and 100=severe pain. Appearance VAS 0-100 where 0=terrible and 100=exceptional
Time Frame
Pain (Weeks 1-16) and Appearance (Weeks 16-52)
Title
Mean Pain and Appearance Scores at Donor Sites (Subject Assessment)
Description
Subject assessment of pain at the RECELL and Control donor sites was performed at all study follow-up visits up to Week 16. Subjects also assessed the satisfaction with the appearance of the donor sites at the Week 16, 24, and 52 study follow-up visits. The subject assessments were performed using VAS (visual analogue scale) style questionnaires. Pain VAS 0-100 where 0=non-existent pain and 100=severe pain. Appearance VAS 0-100 where 0=terrible and 100=exceptional.
Time Frame
Pain (Weeks 1-16) and Appearance (Weeks 16-52)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James H Holmes, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Burn Center at Maricopa Integrated Health Systems
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
University of California Davis Regional Burn Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
The Burn Center at Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Shands Burn Center at University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Indiana University - Richard M. Fairbanks Burn Center at Wishard Memorial Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
NC Jaycee Burn Center at University of NC at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Tennessee Medical Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
USAISR
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
Facility Name
Virginia Commonwealth University Health System- Evans Haynes Burn Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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