A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries
This study is currently recruiting participants.
Verified November 2012 by Avita Medical
Sponsor:
Avita Medical
Collaborators:
Royal Perth Hospital
MedDRA Assistance Inc
BioStat International, Inc.
Information provided by (Responsible Party):
Avita Medical
ClinicalTrials.gov Identifier:
NCT01138917
First received: June 3, 2010
Last updated: November 28, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Burns |
Device: ReCell and Split-thickness skin graft |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries |
Resource links provided by NLM:
Further study details as provided by Avita Medical:
Primary Outcome Measures:
- Recipient site wound closure for both ReCell and STMSG [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]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. The outcomes of the recipient site wound closure will be documented photographically using standardized digital photographic techniques and will be transferred to a Central Reading Facility to be reviewed by qualified Independent Clinical Experts. Avita Medical expects that the wound closure of the ReCell treated recipient sites will be no worse than that obtained using STMSG.
- Superiority of the ReCell donor site healing as compared to STMSG donor site [ Time Frame: 1 week ] [ Designated as safety issue: No ]Donor site healing will be considered as complete (100%) wound closure, defined as the ability to separate the dressing from the wound bed and the visible presence over the entirety of the wound of dry, opalescent-pink external surface of the newly formed outer layer of the epidermis. The outcomes of wound closure will be documented using standardized photographic techniques and will be transferred to a Central Reading Facility to be reviewed by qualified Independent Clinical Experts. Avita Medical expects the wound closure of the ReCell donor sites will be superior to the STMSG donor site.
Secondary Outcome Measures:
- Percent of epithelialization of the ReCell and STMSG treated areas [ Time Frame: all follow-up visits up to week 16 ] [ Designated as safety issue: No ]The percent epithelialization of the ReCell and STMSG treated areas will be assessed using standardized planimetry/tracing procedures and will be forwarded to the Central Reading Facility for calculation using a computerized measurement technique.
- recipient site wound closure [ Time Frame: week 2 ] [ Designated as safety issue: No ]The recipient site wound closure at week 2 will be evaluated using Investigators assessment of wound healing
- Pain and appearance at the ReCell and STMSG treatment areas and at donor sites [ Time Frame: all follow up visits up to week 16 ] [ Designated as safety issue: No ]Subject assessment of pain at the ReCell and STMSG treatment and donor sites will be performed at all study follow-up visits up to week 16. The subject assessments will be performed using VAS ( visual analogue scale) style questionnaires.
| Estimated Enrollment: | 106 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: all participants
All participants will receive both ReCell and split-thickness skin graft
|
Device: 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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138917
Contacts
| Contact: Drina Aldana | 818 3569400 | daldana@avitamedical.com |
| Contact: Andrew Quick | 818 3569400 | aquick@avitamedical.com |
Locations
| United States, Arizona | |
| Arizona Burn Center at Maricopa Integrated Health Systems | Recruiting |
| Phoenix, Arizona, United States, 85008 | |
| Contact: Karen Richey, RN 602-344-5125 karen.richey@hcs.maricopa.gov | |
| Principal Investigator: Kevin Foster, MD, MBA,FACS | |
| United States, California | |
| University of California Davis Regional Burn Center | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Carol Kinkennon, RN 916-453-2136 carol.kinkennon@ucdmc.ucdavis.edu | |
| Principal Investigator: Tina L. Palmieri, MD | |
| United States, District of Columbia | |
| The Burn Center at Washington Hospital Center | Active, not recruiting |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Shands Burn Center at University of Florida | Active, not recruiting |
| Gainesville, Florida, United States, 32610 | |
| Orlando Regional Medical Center | Withdrawn |
| Orlando, Florida, United States, 32806 | |
| Tampa General Hospital | Active, not recruiting |
| Tampa, Florida, United States, 33606 | |
| United States, Illinois | |
| Loyola University Medical Center | Withdrawn |
| Maywood, Illinois, United States, 60153 | |
| United States, Indiana | |
| Indiana University - Richard M. Fairbanks Burn Center at Wishard Memorial Hospital | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: David Roggy 317-630-6399 david.roggy@wishard.edu | |
| Principal Investigator: Rajiv Sood, MD | |
| United States, North Carolina | |
| NC Jaycee Burn Center at University of NC at Chapel Hill | Recruiting |
| Chapel Hill, North Carolina, United States, 27599 | |
| Contact: Carrie Nielsen 919-843-8842 carrie.nielsen@med.unc.edu | |
| Principal Investigator: Bruce A Cairns, MD | |
| Wake Forest University Health Sciences | Active, not recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Tennessee | |
| University of Tennessee Medical Center | Recruiting |
| Memphis, Tennessee, United States, 38163 | |
| Contact: Angela Arnold-Ross, RN 901-834-5834 aarnoldr@uthsc.edu | |
| Principal Investigator: William Hickerson, MD, FACS | |
| United States, Texas | |
| USAISR | Recruiting |
| Fort Sam Houston, Texas, United States, 78234 | |
| Contact: Bryan Jordan 210-916-7154 Bryan.Stephen.Jordan@us.army.mil | |
| Principal Investigator: Booker King, M.D. | |
| Texas Tech University Health Sciences Center | Active, not recruiting |
| Lubbock, Texas, United States, 79430 | |
| United States, Virginia | |
| Virginia Commonwealth University Health System- Evans Haynes Burn Center | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Valentina Lucas, ANP 804-828-3049 | |
| Contact: , MD | |
| Principal Investigator: Feldman Michael, MD | |
| Principal Investigator: Andrea Pozez, MD | |
| United States, Washington | |
| UW Regional Burn Center at Harborview Medical Center | Withdrawn |
| Seattle, Washington, United States, 359796 | |
| Canada, Ontario | |
| Sunnybrook Health Sciences Centre (Ross Tilley Burn Ctr) | Not yet recruiting |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Contact: Marjorie Burnett 416-480-6100 ext 88021 marjorie.burnett@sunnybrook.ca | |
| Principal Investigator: Marc Jeschke, MD | |
Sponsors and Collaborators
Avita Medical
Royal Perth Hospital
MedDRA Assistance Inc
BioStat International, Inc.
Investigators
| Principal Investigator: | James H Holmes, MD | Wake Forest University |
More Information
No publications provided
| Responsible Party: | Avita Medical |
| ClinicalTrials.gov Identifier: | NCT01138917 History of Changes |
| Other Study ID Numbers: | CTP001-5 |
| Study First Received: | June 3, 2010 |
| Last Updated: | November 28, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Avita Medical:
|
Second Degree Burn Injuries |
Additional relevant MeSH terms:
|
Burns Wounds and Injuries |
ClinicalTrials.gov processed this record on May 19, 2013