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RES Prepared With RECELL® Compared to Conventional Care for Healing of Donor Sites in Ages 1-16 Years

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03624192
Recruitment Status : Terminated (Study closed in response to COVID-19 and overall program objectives.)
First Posted : August 10, 2018
Last Update Posted : May 20, 2020
Sponsor:
Collaborator:
Biomedical Advanced Research and Development Authority
Information provided by (Responsible Party):
Avita Medical

Brief Summary:
To evaluate whether the time to complete closure is superior for RECELL-treated split-thickness donor sites, compared with Control (standardized dressings only). The mean time for donor site healing will be compared between treatments.

Condition or disease Intervention/treatment Phase
Skin; Deformity Device: RECELL® Autologous Cell Harvesting Device Other: Telfa™ Clear and Xeroform™ dressings Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Each subject serves as their own control.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of RES (Regenerative Epidermal Suspension) Prepared With the RECELL® Device Compared to Conventional Care for Healing of Donor Sites in Infants, Children and Adolescents (Aged 1-16 Years)
Actual Study Start Date : September 19, 2018
Actual Primary Completion Date : January 13, 2020
Actual Study Completion Date : January 13, 2020

Arm Intervention/treatment
Experimental: RECELL® Autologous Cell Harvesting Device
RECELL + Telfa™ Clear and Xeroform™ dressings
Device: RECELL® Autologous Cell Harvesting Device
Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings
Other Name: RES (Regenerative Epidermal Suspension)

Active Comparator: Telfa™ Clear and Xeroform™ dressings
Telfa™ Clear and Xeroform™ dressings
Other: Telfa™ Clear and Xeroform™ dressings
Telfa™ Clear and Xeroform™ dressings
Other Name: Control




Primary Outcome Measures :
  1. Time to complete closure [ Time Frame: up to 4 weeks ]
    The primary effectiveness endpoint is time (in days) to complete closure of study donor sites confirmed at two consecutive visits.


Secondary Outcome Measures :
  1. Donor site treatment preference (site A or site B) reported by subject [ Time Frame: 4 weeks ]
    Subject will be asked which donor site (A or B) they prefer (if subject is less than 8 years of age parents will be asked)

  2. Donor site treatment preference (site A or site B) reported by physician [ Time Frame: 4 weeks ]
    Physician will be asked which donor site (A or B) they prefer

  3. Comparative itching of study donor sites performed by asking the child which donor site (A or B) was itchier after treatment [ Time Frame: Day 7 ]
    Comparative Itching of study donor sites during 1st week post treatment by asking which site was itchier after treatment

  4. Comparative pain of study donor sites performed by asking the child which donor site (A or B) was more painful since treatment [ Time Frame: Day 7 or 8 ]
    Comparative pain of study donor sites during 1st week post treatment by asking the child which site was more painful since treatment

  5. Blinded Evaluator Overall Opinion Score (1-10) using the Patient and Observer Scar Assessment Scale (POSAS) [ Time Frame: Week 24 ]
    Blinded Evaluator Overall Opinion POSAS Score of study donor sites. The Overall Opinion Score uses a 10-point scale where 10 corresponds to the worst imaginable scar.

  6. Patient Overall Opinion Score (1-10) using the Patient and Observer Scar Assessment Scale (POSAS) [ Time Frame: Week 24 ]
    Patient Overall Opinion POSAS Score of study donor sites(reported by subject 8 years of age or older, or by parent/guardian if subject less than 8 years of age). The Overall Opinion Score uses a 10-point scale where 10 corresponds to the worst imaginable scar.


Other Outcome Measures:
  1. Investigator's (unblinded) assessment of healing at all RECELL-treated areas by direct observation [ Time Frame: Through Week 52 ]
    Investigator's (unblinded) assessment of healing at all RECELL-treated areas including study donor sites by direct observation

  2. Mean subject reported pain score before and after dressing changes [ Time Frame: Up to Week 4 ]
    Mean subject (or parent/guardian) reported study donor site pain prior to and after dressing changes. Faces Pain Scale-Revised (FPS-R) or Numeric Rated Pain Scale will be used based on the child's age. Both scales use a 10-point scale where 10 is the worst pain imaginable or very much pain.

  3. Mean subject reported study donor site itching score prior to dressing changes [ Time Frame: Up to Week 4 ]
    Mean subject (or parent/guardian) reported study donor site itching score prior to dressing changes using the Itch Man Scale (0-4) where 4 represents itching most terribly

  4. Health care provider's mean pain score associated with dressing changes at study donor sites [ Time Frame: Up to Week 4 ]
    Mean pain score associated with dressing changes at study donor sites assessed by the health care provider performing the dressing change using the Face, Legs, Activity, Cry, Consolability (FLACC) scale. The scale is scored in a range of 0-10 with 0 representing no pain.

  5. Blinding effectiveness by asking the Blinded Evaluator which treatment they think the donor sites (A and B) received [ Time Frame: Week 4 and 24 ]
    Blinding effectiveness by asking the Blinded Evaluator which treatment they think the donor sites (A and B) received



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients aged 1 through 16 years (inclusive) with a skin defect for which autografting is indicated.
  2. The area of total injury or planned defect (excluding donor sites) is 5% to 25% Total Body Surface Area (TBSA), inclusive.
  3. Two discrete donor sites of similar size (± 25%) can be created in a similar non-articulating location (excluding the scalp) with each donor site representing a minimum of 1% TBSA.
  4. The patient and family member/parent/guardian are able to complete all follow-up evaluations required by the study protocol.
  5. In the opinion of the Investigator, the patient and/or parent/guardian must be able to:

    1. Understand the full nature and purpose of the study, including possible risks and adverse events, and
    2. Provide informed consent/assent as appropriate for study participation.
  6. The patient and/or parent/guardian agrees to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary and comply with all compulsory study procedures.
  7. The patient and/or parent/guardian agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
  8. The patient and/or parent/guardian can read and understand instructions and give informed, voluntary, written consent.
  9. Life expectancy greater than 52 weeks.

Exclusion Criteria:

  1. Prior autograft harvest at planned study donor sites.
  2. Patients with sepsis or hemodynamic instability.
  3. The patient has an infection under active management or other dermatologic condition at the planned donor sites or treatment areas.
  4. Patient (of reasonable age) or parent/guardian is unable to follow the protocol requirements.
  5. The patient has other concurrent conditions that in the opinion of the Investigator may compromise patient safety or study objectives.
  6. Patients with a known hypersensitivity to trypsin or compound sodium lactate for irrigation.
  7. In post-pubescent girls, pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements).
  8. Enrollment in a concurrent study in which the study treatment may confound the endpoints of this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624192


Locations
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United States, Arizona
Arizona Burn Center at Maricopa Intergrated Health Systems
Phoenix, Arizona, United States, 85008
United States, California
Shriners Hospital for Children, Northern California
Sacramento, California, United States, 95817
University of California at San Diego
San Diego, California, United States, 92103
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Massachusetts
Shriners Hospital for Children, Boston
Boston, Massachusetts, United States, 02114
United States, Ohio
Akron Children's Hospital
Akron, Ohio, United States, 44308
United States, Washington
University of Washington Regional Burn Center at Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Avita Medical
Biomedical Advanced Research and Development Authority
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Responsible Party: Avita Medical
ClinicalTrials.gov Identifier: NCT03624192    
Other Study ID Numbers: CTP006-1
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: May 20, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Avita Medical:
Pediatric, Complex Skin Deformities
Additional relevant MeSH terms:
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Congenital Abnormalities
Skin Abnormalities
Skin Diseases