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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 5 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
The participant and blinded evaluator will be not be told which treatment area received which treatment (RECELL or Control).

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
All Participants (within patient control) 		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.
  • Procedure: Control Intervention (Conventional Autograft)
    Meshed split-thickness skin graft, with standardized wound dressings (Telfa™ Clear and Xeroform™)
    Other names:
    • meshed split-thickness skin graft
  • Device: Investigational Intervention (RECELL + more widely meshed autograft)
    More widely meshed split-thickness skin graft, Spray-on Skin™ Cells prepared using RECELL, and standardized wound dressings (Telfa™ Clear and Xeroform™)

More Details

Status
Completed
Sponsor
Avita Medical

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.