- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01138917
A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Arizona
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Phoenix, Arizona, United States, 85008
- Arizona Burn Center at Maricopa Integrated Health Systems
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California
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Sacramento, California, United States, 95817
- University of California Davis Regional Burn Center
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District of Columbia
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Washington, District of Columbia, United States, 20010
- The Burn Center at Washington Hospital Center
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Florida
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Gainesville, Florida, United States, 32610
- Shands Burn Center at University of Florida
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Tampa, Florida, United States, 33606
- Tampa General Hospital
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University - Richard M. Fairbanks Burn Center at Wishard Memorial Hospital
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- NC Jaycee Burn Center at University of NC at Chapel Hill
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest University Health Sciences
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Tennessee
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Memphis, Tennessee, United States, 38163
- University of Tennessee Medical Center
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Texas
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Fort Sam Houston, Texas, United States, 78234
- USAISR
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Lubbock, Texas, United States, 79430
- Texas Tech University Health Sciences Center
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Virginia
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Richmond, Virginia, United States, 23298
- Virginia Commonwealth University Health System- Evans Haynes Burn Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: all participants
All participants will receive both ReCell and split-thickness skin graft
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of RECELL-treated Area Closure Compared to Control at 4 Weeks (Non-inferiority)
Time Frame: 4 weeks
|
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.
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4 weeks
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Incidence of RECELL Donor Site Healing Compared to Control at 1 Week (Superiority)
Time Frame: 1 week
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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.
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1 week
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent of Epithelialization at Each Visit Through Week 16
Time Frame: Each visit through Week 16
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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.
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Each visit through Week 16
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Wound Closure at Week 2 (Based on Investigators Assessment)
Time Frame: Week 2
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The proportion of recipient sites achieving wound closure at Week 2 was evaluated using the Investigators assessment of wound healing.
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Week 2
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Mean Pain and Appearance Scores at RECELL and Control Recipient Sites (Subject Assessment)
Time Frame: Pain (Weeks 1-16) and Appearance (Weeks 16-52)
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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 |
Pain (Weeks 1-16) and Appearance (Weeks 16-52)
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Mean Pain and Appearance Scores at Donor Sites (Subject Assessment)
Time Frame: Pain (Weeks 1-16) and Appearance (Weeks 16-52)
|
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. |
Pain (Weeks 1-16) and Appearance (Weeks 16-52)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: James H Holmes, MD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTP001-5
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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