Clinical trial NCT02380612: ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries
Official title: Demonstration of the Safety and Effectiveness of ReCell® Combined With Meshed Skin Graft for Reduction of Donor Area in the Treatment of Acute Burn Injuries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Keywords: Second Degree Burn Injuries
Lead sponsor: Avita Medical
Sponsor class: INDUSTRY
Collaborators: name: MedDRA Assistance Inc
name: Advanced Clinical Research Services, LLC
First posted: 2015-03-05
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, within-subject controlled study to compare the clinical performance of the ReCell device when used as an adjunct to meshed skin graft in subjects requiring skin grafts for closure of burn injuries. Co-primary effectiveness endpoints include: (1) confirmed treatment area closure (i.e., healing) prior to or at 8 weeks as assessed by a blinded evaluator, and (2) a comparison of the actual expansion ratio, computed as the ratio of measured treated area to the measured donor site area, achieved for the ReCell-treated and control treatment areas. Safety will be evaluated in terms of long-term durability, scar outcomes and treatment-related adverse events.


Eligibility criteria: Inclusion Criteria:

1. The subject requires skin grafting as a result of an acute thermal burn injury (i.e. injuries caused by exposure of the skin to fire/flames, excessive heat, hot steam or water).
2. The area of total burn injury is 5-50% TBSA inclusive.
3. Two areas requiring skin grafting, each at least 300cm2 (or 600cm2 contiguous), excluding hand/face and joints.
4. The subject is at least 5 years of age.
5. The subject (or family, for those under 18 years of age) is willing and able to complete all followup evaluations required by the study protocol.
6. The subject is to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary.
7. The subject agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
8. The subject and/or guardian are able to read and understand instructions and give informed, voluntary, written consent.

Exclusion Criteria:

1. The subject's burn injuries were caused by chemicals, electricity, and/or radioactive substances.
2. The subject is unable to follow the protocol.
3. The subject has other concurrent conditions that in the opinion of the investigator may compromise patient safety or study objectives.
4. The subject has a known hypersensitivity to trypsin or compound sodium lactate for irrigation (Hartmann's) solution.
5. Life expectancy is less than 1 year.

Primary outcomes:
measure: Number of Participants With Confirmed Treatment Area Closure of RECELL-treated Wounds Compared to Control (Non-inferiority)
timeFrame: Prior to or at 8 weeks
measure: Actual Expansion Ratios (Treatment Area to Donor Site Area, Inclusive of Donor Skin Needed for Secondary Treatments)
timeFrame: Prior to or at 8 weeks
Secondary outcomes:
measure: Observer Overall Patient and Observer Scar Assessment Scale ( POSAS) Opinion Score
timeFrame: At 24 Week
measure: Patient's Satisfaction/Treatment Preference
timeFrame: At 24 Week
measure: Patient Overall Patient and Observer Scar Assessment Scale (POSAS) Opinion Score
timeFrame: Week 24
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Burn Center at Maricopa Medical Center
state: Arizona
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Chapel Hill
country: United States
facility: North Carolina Jaycee Burn Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
city: Fort Sam Houston
country: United States
facility: USAISR - US Army Institute of Surgical Research
state: Texas
Study officials:
affiliation: Wake Forest University Health Sciences
name: James H Holmes, IV, MD
role: PRINCIPAL_INVESTIGATOR
References: