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BurnsNCT01138917

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

A study testing ReCell and Split-thickness skin graft in people with Burns, run by Avita Medical at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Burns
What is being tested?
ReCell and Split-thickness skin graft
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
12 sitesUnited States
Study dates
21 May 2010to 26 Aug 2015
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • NC Jaycee Burn Center at University of NC at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • USAISR

    Fort Sam Houston, Texas, 78234

  • Shands Burn Center at University of Florida

    Gainesville, Florida, 32610

  • Indiana University - Richard M. Fairbanks Burn Center at Wishard Memorial Hospital

    Indianapolis, Indiana, 46202

  • Texas Tech University Health Sciences Center

    Lubbock, Texas, 79430

  • University of Tennessee Medical Center

    Memphis, Tennessee, 38163

  • Arizona Burn Center at Maricopa Integrated Health Systems

    Phoenix, Arizona, 85008

  • Virginia Commonwealth University Health System- Evans Haynes Burn Center

    Richmond, Virginia, 23298

  • University of California Davis Regional Burn Center

    Sacramento, California, 95817

  • Tampa General Hospital

    Tampa, Florida, 33606

  • The Burn Center at Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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.

Conditions
Burns
Being tested
ReCell and Split-thickness skin graft
Keywords
Second Degree Burn Injuries
Medical subject headings
Burns

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ReCell and Split-thickness skin graftDevice

    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.

Study groups in NCT01138917
Study groupRoleWhat they receive
all participantsExperimentalAll participants will receive both ReCell and split-thickness skin graft
Receives: Device: ReCell and Split-thickness skin graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 weeks

  2. 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.

    Measured: 1 week

Secondary outcomes (4)

  1. 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.

    Measured: Each visit through Week 16

  2. 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.

    Measured: Week 2

  3. 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

    Measured: Pain (Weeks 1-16) and Appearance (Weeks 16-52)

  4. 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.

    Measured: Pain (Weeks 1-16) and Appearance (Weeks 16-52)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2010 (estimated)
  2. Study start21 May 2010
  3. Primary completion29 Aug 2014
  4. Study completion26 Aug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01138917
Sponsor's protocol ID
CTP001-5
Status last verified
May 2019
First submitted
3 Jun 2010
Last updated
13 May 2019
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing ReCell and Split-thickness skin graft in people with Burns, run by Avita Medical at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of RECELL-treated Area Closure Compared to Control at 4 Weeks (Non-inferiority) (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01138917.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2019.

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