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

Skin; Deformity Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03624192
• Other study ID #: CTP006-1
• Status: Terminated
• Phase: N/A
• Start date: September 19, 2018
• Est. completion date: January 13, 2020

Study information

• Verified date: July 2021
• Source: Avita Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 13, 2020
• Est. primary completion date: January 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Skin Abnormalities
• Skin; Deformity

Intervention

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:
• Telfa™ Clear and Xeroform™ dressings
Telfa™ Clear and Xeroform™ dressings

Locations

Country	Name	City	State
United States	Akron Children's Hospital	Akron	Ohio
United States	Shriners Hospital for Children, Boston	Boston	Massachusetts
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Arizona Burn Center at Maricopa Intergrated Health Systems	Phoenix	Arizona
United States	Shriners Hospital for Children, Northern California	Sacramento	California
United States	University of California at San Diego	San Diego	California
United States	University of Washington Regional Burn Center at Harborview Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Avita Medical	Biomedical Advanced Research and Development Authority

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Through Week 52
Other	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.	Up to Week 4
Other	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	Up to Week 4
Other	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.	Up to Week 4
Other	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	Week 4 and 24
Primary	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.	up to 4 weeks
Secondary	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)	4 weeks
Secondary	Donor Site Treatment Preference (Site A or Site B) Reported by Physician	Physician will be asked which donor site (A or B) they prefer	4 weeks
Secondary	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	Day 7
Secondary	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	Day 7 or 8
Secondary	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.	Week 24
Secondary	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.	Week 24