Clinical trial NCT04091672: RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Full-thickness Skin Defects
Degloving Injuries
Crush Injuries
Laceration of Skin
Surgical Wound
Skin Cancer
Cellulitis
Infection
Necrotizing Fasciitis
Gun Shot Wound
Lead sponsor: Avita Medical
Sponsor class: INDUSTRY
First posted: 2019-09-17
Enrollment: 65
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Treatment Area Healing
timeFrame: Prior to or at 8 weeks
measure: Donor Skin Area to Treatment Area Expansion Ratio
timeFrame: Treatment Day
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Burn Center - Valleywise Health
state: Arizona
city: Tucson
country: United States
facility: University of Arizona - Banner Health
state: Arizona
city: Orange
country: United States
facility: UCI Medical Center
state: California
city: Torrance
country: United States
facility: Lundquist Institute @Harbor UCLA
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Miami
country: United States
facility: Kendall Regional Medical Center
state: Florida
city: Chicago
country: United States
facility: Cook County Health
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: New Orleans
country: United States
facility: University Medical Center
state: Louisiana
city: New York
country: United States
facility: University of Rochester Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Fort Worth
country: United States
facility: JPS Health Network
state: Texas
city: San Antonio
country: United States
facility: Metis Foundation
state: Texas
Study officials:
References: