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

AVITA Medical

Status: Terminated

Conditions: Skin; Deformity

Treatments: Device: RECELL® Autologous Cell Harvesting Device; Other: Telfa™ Clear and Xeroform™ dressings

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT03624192

CTP006-1

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 1 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3 participants in 2 patient groups

RECELL® Autologous Cell Harvesting Device

Experimental group

Description:

RECELL + Telfa™ Clear and Xeroform™ dressings

Treatment:

Device: RECELL® Autologous Cell Harvesting Device

Telfa™ Clear and Xeroform™ dressings

Active Comparator group

Description:

Telfa™ Clear and Xeroform™ dressings

Treatment:

Other: Telfa™ Clear and Xeroform™ dressings