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

• Sponsor: Avita Medical (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04091672
• Collaborator: (none)
• Enrollment: 65
• Locations: 18
• Arm: 1
• Anticipated Duration (Months): 35
• Patients Per Site: 3.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Full-thickness Skin Defects; Degloving Injuries; Crush Injuries; Laceration of Skin; Surgical Wound; Skin Cancer; Cellulitis; Infection; Necrotizing Fasciitis; Gun Shot Wound	Device: Autografting with RECELL overspray; Procedure: Conventional Autografting	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 65 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• 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).
• Primary Purpose: Treatment
• Official Title: A Prospective Multicenter Randomized Controlled Clinical Study to Investigate the Safety and Effectiveness of the RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction
• Actual Study Start Date: Mar 2, 2020
• Actual Primary Completion Date: Mar 7, 2022
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: All Participants (within patient control) All subjects will receive both RECELL and skin graft. Each patient serves as their own control. Their study treatment area will be divided into Area A and Area B. Investigational treatment (RECELL) will be randomly allocated to either Area A or Area B	Device: Autografting with RECELL overspray; Autografting more widely meshed than the pre-specified grafting plan with RECELL overspray, along with Telfa™ Clear and Xeroform™ wound dressings; Procedure: Conventional Autografting; Autografting according to the pre-specified grafting plan, along with Telfa™ Clear and Xeroform™ wound dressings

Outcome Measures

Primary Outcome Measures

1. Confirmed Healing [Prior to or at 8 weeks]

   Healing is defined as complete closure characterized by 100% skin re-epithelialization without drainage, confirmed at two consecutive study visits at least 2 weeks apart by direct visualization by a Blinded Evaluator. The incidence of healing is hypothesized to be non-inferior for RECELL-treated areas as compared to Control areas.

2. Actual Expansion Ratios [Prior to or at 8 weeks]

   Actual expansion ratio, computed as the ratio of measured treated area to the measured donor site area, will be calculated separately for RECELL and Control (including donor skin needed for secondary treatments). The actual expansion ratios will be compared as a new ratio (ratio of ratios). The actual expansion ratio achieved with the use of RECELL is hypothesized to be superior to the actual expansion ratio associated with the Control.

Other Outcome Measures

1. POSAS (Patient and Observer Scar Assessment Scale) [At weeks 26, 36 and 52]

   Blinded evaluator and subject overall opinion score (1-10), where 10 corresponds to the worst imaginable scar

2. Subject Treatment Preference [At week 52]

   Subjects will be asked to specify which treatment region they are more satisfied with (A or B)

3. Investigator Treatment Preference [At week 52]

   Investigators will be asked to specify which treatment region they are more satisfied with (A or B)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years and Older
• Sexes Eligible for Study: 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:

9. Understand the full nature and purpose of the study, including possible risks and adverse events,

10. Understand instructions, and

11. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Burn Center - Valleywise Health	Phoenix	Arizona	United States	85008
2	University of Arizona - Banner Health	Tucson	Arizona	United States	85719
3	UCI Medical Center	Orange	California	United States	92868
4	Lundquist Institute @Harbor UCLA	Torrance	California	United States	90502
5	MedStar Washington Hospital Center	Washington	District of Columbia	United States	20010
6	Kendall Regional Medical Center	Miami	Florida	United States	33175
7	Cook County Health	Chicago	Illinois	United States	60612
8	Carle Foundation Hospital	Urbana	Illinois	United States	61801
9	University Medical Center	New Orleans	Louisiana	United States	70112
10	University of Rochester Medical Center	New York	New York	United States	14642
11	Duke University Hospital	Durham	North Carolina	United States	27710
12	Wake Forest University Health Sciences	Winston-Salem	North Carolina	United States	27157
13	Ohio State University	Columbus	Ohio	United States	43210
14	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107
15	Temple University	Philadelphia	Pennsylvania	United States	19140
16	Rhode Island Hospital	Providence	Rhode Island	United States	02903
17	JPS Health Network	Fort Worth	Texas	United States	76104
18	Metis Foundation	San Antonio	Texas	United States	78216

Sponsors and Collaborators

• Avita Medical

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Avita Medical
• ClinicalTrials.gov Identifier: NCT04091672
• Other Study ID Numbers: CTP007
• First Posted: Sep 17, 2019
• Last Update Posted: Apr 8, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Cellulitis; Fasciitis; Fasciitis, Necrotizing; Wounds and Injuries; Surgical Wound; Lacerations; Crush Injuries; Degloving Injuries; Wounds, Gunshot

Study Results

No Results Posted as of Apr 8, 2022