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TerminatedNCT03624192Updated Jul 18, 2024Results posted

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

An interventional study of RECELL® Autologous Cell Harvesting Device and Telfa™ Clear and Xeroform™ dressings in Skin; Deformity, sponsored by Avita Medical. Terminated at 7 sites in United States. Open to participants aged 1 Year to 16 Years. Per ClinicalTrials.gov, last updated 2024-07-18.

Sponsored by Avita Medical · Not applicable, Interventional, and Treatment

Why this study was terminated
Study closed in response to COVID-19 and overall program objectives.
Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Randomized
Ages
1 Year to 16 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Skin; Deformity

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Keywords

  • Pediatric, Complex Skin Deformities
03

In context

Skin Abnormalities

39 studies on the registry are indexed under Skin Abnormalities; 7 are open to participants now.

This study's enrollment of 3 is below the median of 39 across 26 interventional studies indexed under Skin Abnormalities.

Browse Skin Abnormalities studies →

Lead sponsor

Avita Medical is the lead sponsor of 15 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 /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. greater than 52 weeks.

Exclusion criteria

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 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    RECELL® Autologous Cell Harvesting Device

    RECELL + Telfa™ Clear and Xeroform™ dressings

    Device: RECELL® Autologous Cell Harvesting Device

  • Active comparator
    Telfa™ Clear and Xeroform™ dressings

    Telfa™ Clear and Xeroform™ dressings

    Other: Telfa™ Clear and Xeroform™ dressings

Interventions

  • DeviceRECELL® 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

    Also known as: RES (Regenerative Epidermal Suspension)

  • OtherTelfa™ Clear and Xeroform™ dressings

    Telfa™ Clear and Xeroform™ dressings

    Also known as: Control

06

What researchers measure

Primary outcomes

  1. Time to Complete Closure

    The primary effectiveness endpoint is time, in days, to complete closure (≥95% epithelialization by blinded assessor) of study donor sites confirmed at two consecutive visits.

    Time frame: up to 4 weeks

Secondary outcomes

  1. Donor Site Treatment Preference (Site A or Site B) Reported by Subject

    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)

    Time frame: 4 weeks

  2. Donor Site Treatment Preference (Site A or Site B) Reported by Physician

    Physician will be asked which donor site (A or B) they prefer

    Time frame: 4 weeks

  3. Comparative Itching of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was Itchier After Treatment

    Comparative Itching of study donor sites during 1st week post treatment by asking which site was itchier after treatment

    Time frame: Day 7

  4. Comparative Pain of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was More Painful Since Treatment

    Comparative pain of study donor sites during 1st week post treatment by asking the child which site was more painful since treatment

    Time frame: Day 7 or 8

  5. Blinded Evaluator Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS)

    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.

    Time frame: Week 24

  6. Patient Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS)

    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.

    Time frame: Week 24

Other outcomes

  1. Investigator's (Unblinded) Assessment of Healing at All RECELL-treated Areas by Direct Observation

    Investigator's (unblinded) assessment of healing at all RECELL-treated areas including study donor sites by direct observation

    Time frame: Through Week 52

  2. Mean Subject Reported Pain Score Before and After Dressing Changes

    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.

    Time frame: Up to Week 4

  3. Mean Subject Reported Study Donor Site Itching Score Prior to Dressing Changes

    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

    Time frame: Up to Week 4

  4. Health Care Provider's Mean Pain Score Associated With Dressing Changes at Study Donor Sites

    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.

    Time frame: Up to Week 4

  5. Blinding Effectiveness by Asking the Blinded Evaluator Which Treatment They Think the Donor Sites (A and B) Received

    Blinding effectiveness by asking the Blinded Evaluator which treatment they think the donor sites (A and B) received

    Time frame: Week 4 and 24

07

Results

Posted Jul 28, 2021

Participant flow

Participant flow — Overall Study
MilestoneRECELLControl
Started33
Completed22
Not completed11
Withdrew: Lost to follow-up11

Outcome measures

PrimaryTime to Complete Closure

The primary effectiveness endpoint is time, in days, to complete closure (≥95% epithelialization by blinded assessor) of study donor sites confirmed at two consecutive visits.

Time frame:
up to 4 weeks
Reported as:
Number · Days
Time to Complete Closure
DaysRECELLControl
Subject 0011010
Subject 0031411
Subject 0041313
SecondaryDonor Site Treatment Preference (Site A or Site B) Reported by Subject

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)

Time frame:
4 weeks
Reported as:
Number · Participants
Donor Site Treatment Preference (Site A or Site B) Reported by Subject
ParticipantsAll Participants
RECELL1
Control1
No Response1
SecondaryDonor Site Treatment Preference (Site A or Site B) Reported by Physician

Physician will be asked which donor site (A or B) they prefer

Time frame:
4 weeks
Reported as:
Number · Physician Response
Donor Site Treatment Preference (Site A or Site B) Reported by Physician
Physician ResponseAll Participants
RECELL1
Control0
Unable to determine/no preference2
SecondaryComparative Itching of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was Itchier After Treatment

Comparative Itching of study donor sites during 1st week post treatment by asking which site was itchier after treatment

Time frame:
Day 7
Reported as:
Number · Participants
Comparative Itching of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was Itchier After Treatment
ParticipantsAll Participants
RECELL0
Control0
No difference/Can't tell3
SecondaryComparative Pain of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was More Painful Since Treatment

Comparative pain of study donor sites during 1st week post treatment by asking the child which site was more painful since treatment

Time frame:
Day 7 or 8
Reported as:
Number · Participants
Comparative Pain of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was More Painful Since Treatment
ParticipantsAll Participants
RECELL0
Control0
No Pain at Either Donor SIte1
No Difference/Can't Tell2
SecondaryBlinded Evaluator Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS)

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.

Time frame:
Week 24
Reported as:
Number · Score on a scale
Blinded Evaluator Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS)
Score on a scaleRECELLControl
Subject 00329
Subject 00423
SecondaryPatient Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS)

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.

Time frame:
Week 24
Reported as:
Number · Score on a scale
Patient Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS)
Score on a scaleRECELL® Autologous Cell Harvesting DeviceTelfa™ Clear and Xeroform™ Dressings
Subject 003510
Other pre-specifiedInvestigator's (Unblinded) Assessment of Healing at All RECELL-treated Areas by Direct Observation

Investigator's (unblinded) assessment of healing at all RECELL-treated areas including study donor sites by direct observation

Time frame:
Through Week 52

Results for this outcome have not been posted.

Other pre-specifiedMean Subject Reported Pain Score Before and After Dressing Changes

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.

Time frame:
Up to Week 4

Results for this outcome have not been posted.

Other pre-specifiedMean Subject Reported Study Donor Site Itching Score Prior to Dressing Changes

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

Time frame:
Up to Week 4

Results for this outcome have not been posted.

Other pre-specifiedHealth Care Provider's Mean Pain Score Associated With Dressing Changes at Study Donor Sites

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.

Time frame:
Up to Week 4

Results for this outcome have not been posted.

Other pre-specifiedBlinding Effectiveness by Asking the Blinded Evaluator Which Treatment They Think the Donor Sites (A and B) Received

Blinding effectiveness by asking the Blinded Evaluator which treatment they think the donor sites (A and B) received

Time frame:
Week 4 and 24

Results for this outcome have not been posted.

Adverse events

Collected over 52 Weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Experimental: All Participants (Within Patient Control)0/3 (0%)0/3 (0%)1/3 (33.3%)
Most frequent other events
Most frequent other events
EventExperimental: All Participants (Within Patient Control)
Graft Loss 135cm2Injury, poisoning and procedural complications1/3

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Experimental: All Participants (Within Patient Control)
<=18 years3
Between 18 and 65 years0
>=65 years0
Age, Continuous
Age, Continuous(Years)Experimental: All Participants (Within Patient Control)
Mean3.7 ± 2.08
Sex: Female, Male
Sex: Female, Male(Participants)Experimental: All Participants (Within Patient Control)
Female1
Male2
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Experimental: All Participants (Within Patient Control)
Hispanic or Latino1
Not Hispanic or Latino2
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Experimental: All Participants (Within Patient Control)
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American0
White3
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Experimental: All Participants (Within Patient Control)
United States3
08

Study locations

7 sites
  • Arizona Burn Center at Maricopa Intergrated Health Systems
    Phoenix, Arizona 85008, United States
  • Shriners Hospital for Children, Northern California
    Sacramento, California 95817, United States
  • University of California at San Diego
    San Diego, California 92103, United States
  • University of Iowa Hospitals and Clinics
    Iowa City, Iowa 52242, United States
  • Shriners Hospital for Children, Boston
    Boston, Massachusetts 02114, United States
  • Akron Children's Hospital
    Akron, Ohio 44308, United States
  • University of Washington Regional Burn Center at Harborview Medical Center
    Seattle, Washington 98104, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03624192
Lead sponsor
Avita Medical
Collaborators
Biomedical Advanced Research and Development Authority
Responsible party
Sponsor
First posted
Aug 10, 2018
Start date
Sep 19, 2018
Primary completion
Jan 13, 2020
Completion
Jan 13, 2020
Results posted
Jul 28, 2021
Last update
Jul 18, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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