Clinical trial NCT03624192: RES Prepared With RECELL® Compared to Conventional Care for Healing of Donor Sites in Ages 1-16 Years
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Skin; Deformity
Keywords: Pediatric, Complex Skin Deformities
Lead sponsor: Avita Medical
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
First posted: 2018-08-10
Enrollment: 3
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each subject serves as their own control.
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Time to Complete Closure
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Donor Site Treatment Preference (Site A or Site B) Reported by Subject
timeFrame: 4 weeks
measure: Donor Site Treatment Preference (Site A or Site B) Reported by Physician
timeFrame: 4 weeks
measure: Comparative Itching of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was Itchier After Treatment
timeFrame: Day 7
measure: Comparative Pain of Study Donor Sites Performed by Asking the Child Which Donor Site (A or B) Was More Painful Since Treatment
timeFrame: Day 7 or 8
measure: Blinded Evaluator Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: Week 24
measure: Patient Overall Opinion Score (1-10) Using the Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: Week 24
Other outcomes:
measure: Investigator's (Unblinded) Assessment of Healing at All RECELL-treated Areas by Direct Observation
timeFrame: Through Week 52
measure: Mean Subject Reported Pain Score Before and After Dressing Changes
timeFrame: Up to Week 4
measure: Mean Subject Reported Study Donor Site Itching Score Prior to Dressing Changes
timeFrame: Up to Week 4
measure: Health Care Provider's Mean Pain Score Associated With Dressing Changes at Study Donor Sites
timeFrame: Up to Week 4
measure: Blinding Effectiveness by Asking the Blinded Evaluator Which Treatment They Think the Donor Sites (A and B) Received
timeFrame: Week 4 and 24
Locations:
city: Phoenix
country: United States
facility: Arizona Burn Center at Maricopa Intergrated Health Systems
state: Arizona
city: Sacramento
country: United States
facility: Shriners Hospital for Children, Northern California
state: California
city: San Diego
country: United States
facility: University of California at San Diego
state: California
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Boston
country: United States
facility: Shriners Hospital for Children, Boston
state: Massachusetts
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
city: Seattle
country: United States
facility: University of Washington Regional Burn Center at Harborview Medical Center
state: Washington
Study officials:
References: