RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction

AVITA Medical

Status: Completed

Conditions: Infection; Cellulitis; Full-thickness Skin Defects; Surgical Wound; Skin Cancer; Laceration of Skin; Necrotizing Fasciitis; Crush Injuries; Degloving Injuries; Gun Shot Wound

Treatments: Procedure: Control Intervention (Conventional Autograft); Device: Investigational Intervention (RECELL + more widely meshed autograft)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04091672

CTP007

Details and patient eligibility

About

A prospective randomized within-subject controlled study to compare the clinical performance of conventional autografting with and without the RECELL system on acute non-burn full-thickness skin defects.

Enrollment: 65 patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patient requires autografting for treatment of an acute full-thickness skin defect (e.g., trauma- or surgery-related).

2. The maximum area requiring autografting is 50% Total Body Surface Area (TBSA).

3. Two comparable areas requiring autografting, each at least 160 cm2 (or 320 cm2 contiguous), excluding face and genitalia. When hands or joints are included in the treatment areas, comparability of treatment areas means that each area (RECELL and Control) must include the same contralateral joint and/or hand.

4. The patient is at least 5 years of age.

5. The patient (or parent/guardian) is willing and able to comply with all compulsory study procedures and visit schedule.

6. The patient agrees to abstain from any other treatment (e.g., external fixation) of the study treatment areas for the duration of his/her participation the study (1 year).

7. The patient agrees to abstain from enrollment in any other interventional clinical trial for the duration of his/her participation the study (1 year).

8. In the opinion of the investigator, the patient and/or guardian must be able to:

   1. Understand the full nature and purpose of the study, including possible risks and adverse events,
   2. Understand instructions, and
   3. Provide voluntary informed written consent.

Exclusion criteria

1. Not able to understand English or Spanish.
2. The area requiring autografting sustained a burn injury.
3. The treatment area has previously failed to heal subsequent to surgical intervention for closure.
4. The patient is unable to follow the protocol requirements.
5. The patient has a condition that in the investigator's opinion may compromise patient safety or trial objectives.
6. Current use of medications that in the investigator's opinion may compromise patient safety or trial objectives.
7. The patient has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
8. The patient is pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements).
9. Life expectancy is less than 1 year.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

All Participants (within patient control)

Experimental group

Description:

Each participant will serve as their own Control, receiving both Control and Investigational Interventions randomly allocated to treatment of a portion of a full-thickness skin defect.

Treatment:

Device: Investigational Intervention (RECELL + more widely meshed autograft)

Procedure: Control Intervention (Conventional Autograft)