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

Primary Purpose

Skin; Deformity

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

RECELL® Autologous Cell Harvesting Device

Telfa™ Clear and Xeroform™ dressings

About this trial

This is an interventional treatment trial for Skin; Deformity focused on measuring Pediatric, Complex Skin Deformities

Eligibility Criteria

1 Year - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female patients aged 1 through 16 years (inclusive) with a skin defect for which autografting is indicated.
The area of total injury or planned defect (excluding donor sites) is 5% to 25% Total Body Surface Area (TBSA), inclusive.
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.
The patient and family member/parent/guardian are able to complete all follow-up evaluations required by the study protocol.
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.
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.
The patient and/or parent/guardian agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
The patient and/or parent/guardian can read and understand instructions and give informed, voluntary, written consent.
Life expectancy greater than 52 weeks.

Exclusion Criteria:

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

Sites / Locations

Arizona Burn Center at Maricopa Intergrated Health Systems
Shriners Hospital for Children, Northern California
University of California at San Diego
University of Iowa Hospitals and Clinics
Shriners Hospital for Children, Boston
Akron Children's Hospital
University of Washington Regional Burn Center at Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RECELL® Autologous Cell Harvesting Device

Telfa™ Clear and Xeroform™ dressings

Arm Description

RECELL + Telfa™ Clear and Xeroform™ dressings

Telfa™ Clear and Xeroform™ dressings

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

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

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

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

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

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.

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.

Full Information

NCT ID

NCT03624192

First Posted

July 20, 2018

Last Updated

July 7, 2021

Sponsor

Avita Medical

Collaborators

Biomedical Advanced Research and Development Authority

1. Study Identification

Unique Protocol Identification Number

NCT03624192

Brief Title

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

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Terminated

Why Stopped

Study closed in response to COVID-19 and overall program objectives.

Study Start Date

September 19, 2018 (Actual)

Primary Completion Date

January 13, 2020 (Actual)

Study Completion Date

January 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Avita Medical

Collaborators

Biomedical Advanced Research and Development Authority

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Skin; Deformity

Keywords

Pediatric, Complex Skin Deformities

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Each subject serves as their own control.

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RECELL® Autologous Cell Harvesting Device

Arm Type

Experimental

Arm Description

RECELL + Telfa™ Clear and Xeroform™ dressings

Arm Title

Telfa™ Clear and Xeroform™ dressings

Arm Type

Active Comparator

Arm Description

Telfa™ Clear and Xeroform™ dressings

Intervention Type

Device

Intervention Name(s)

RECELL® Autologous Cell Harvesting Device

Other Intervention Name(s)

RES (Regenerative Epidermal Suspension)

Intervention Description

Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings

Intervention Type

Other

Intervention Name(s)

Telfa™ Clear and Xeroform™ dressings

Other Intervention Name(s)

Control

Intervention Description

Telfa™ Clear and Xeroform™ dressings

Primary Outcome Measure Information:

Title

Time to Complete Closure

Description

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 Outcome Measure Information:

Title

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

Description

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

Title

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

Description

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

Time Frame

4 weeks

Title

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

Description

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

Time Frame

Day 7

Title

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

Description

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

Title

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

Description

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

Title

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

Description

Time Frame

Week 24

Other Pre-specified Outcome Measures:

Title

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

Description

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

Time Frame

Through Week 52

Title

Mean Subject Reported Pain Score Before and After Dressing Changes

Description

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

Title

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

Description

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

Title

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

Description

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

Title

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

Description

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

Time Frame

Week 4 and 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patients aged 1 through 16 years (inclusive) with a skin defect for which autografting is indicated. The area of total injury or planned defect (excluding donor sites) is 5% to 25% Total Body Surface Area (TBSA), inclusive. 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. The patient and family member/parent/guardian are able to complete all follow-up evaluations required by the study protocol. In the opinion of the Investigator, the patient and/or parent/guardian must be able to: Understand the full nature and purpose of the study, including possible risks and adverse events, and Provide informed consent/assent as appropriate for study participation. 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. The patient and/or parent/guardian agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study. The patient and/or parent/guardian can read and understand instructions and give informed, voluntary, written consent. Life expectancy greater than 52 weeks. Exclusion Criteria: Prior autograft harvest at planned study donor sites. Patients with sepsis or hemodynamic instability. The patient has an infection under active management or other dermatologic condition at the planned donor sites or treatment areas. Patient (of reasonable age) or parent/guardian is unable to follow the protocol requirements. The patient has other concurrent conditions that in the opinion of the Investigator may compromise patient safety or study objectives. Patients with a known hypersensitivity to trypsin or compound sodium lactate for irrigation. In post-pubescent girls, pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements). Enrollment in a concurrent study in which the study treatment may confound the endpoints of this study.

Facility Information:

Facility Name

Arizona Burn Center at Maricopa Intergrated Health Systems

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85008

Country

United States

Facility Name

Shriners Hospital for Children, Northern California

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

Country

United States

Facility Name

University of California at San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

University of Iowa Hospitals and Clinics

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

Shriners Hospital for Children, Boston

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Akron Children's Hospital

City

Akron

State/Province

Ohio

ZIP/Postal Code

44308

Country

United States

Facility Name

University of Washington Regional Burn Center at Harborview Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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