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
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
Sponsor: Avita Medical

 
 
 
 
  
 
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 
 
Investigational Plan 
Study Number:  
 
CTP007 
Device:  
 
 
RECELL® Autologous Cell Harvesting Device 
Study Type:  
 
Pivotal Study 
IDE Reference Number: 
13053 
Date:  
 
October 30, 2020 / Revision 2 
Sponsor:  
 
 
AVITA Medical  
28159 Avenue Stanford, Suite 220 
Valencia, CA 91355 
 
 
 
 
 
 
 
 
PRINCIPAL INVESTIGATOR’S STATEMENT 
This statement is to certify that I have received the above-referenced investigational plan, which 
has been approved for initiation at my investigational site by the Institutional Review Board. As 
Principal Investigator, I will ensure that all personnel who have been delegated responsibilities for 
this study will be trained on the investigational plan and associated responsibilities prior to study 
participation.  I agree to conduct this clinical study in compliance with the investigational plan and 
applicable requirements of the U.S. Code of Federal Regulations (21 CFR Parts, 50, 54, 56, 812 
and 45 CFR Part 46). 
 
Print Name: _______________________________________ 
 
                 Principal Investigator                   
 
Signature: ____________________________________ 
Date: _______________ 
                                   Principal Investigator 

PROTOCOL SYNOPSIS 
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 Area in Soft Tissue Reconstruction 
Protocol No. 
CTP007 
Phase of Study 
Pivotal Study 
Intended Use 
The RECELL® Autologous Cell Harvesting Device is indicated for use in 
combination with meshed autografting for treatment of acute full-thickness skin 
defects such as degloving, crush, laceration (including pretibial), and surgical 
wounds (e.g., flap donor, skin cancer resection, post-debridement for cellulitis or 
infection). 
Primary Objective 
To evaluate the safety and effectiveness of the RECELL Device when used as an 
adjunct to meshed autografts in patients undergoing reconstruction of skin defects 
not associated with a burn injury.  
Planned Enrollment 
A minimum of 65 subjects will be enrolled and randomized in the study to evaluate 
the coprimary endpoints. 
This study utilizes an adaptive design with planned sample size re-estimation in 
order to maintain adequate conditional power. The maximum enrollment will be 
126 subjects. 
Number of Trial Centers 
Up to 20 trial centers in the United States (US) may participate. 
Clinical 
Justification/Benefit 
Use of RECELL as an adjunct to autografts meshed more widely than conventional 
meshed autografts will allow for reduction in donor skin harvesting required for 
autografting. Donor site morbidity, including pain, infection and delayed healing, 
are reduced for smaller donor areas; therefore, reduction of donor skin harvesting 
offers clinical benefit. 
Investigational 
Treatment 
Skin cell suspension prepared using the RECELL Device will be applied over 
autografts meshed more widely than a standardized comparator.  
Control Treatment 
Conventional autografting 
Study Design 
This is a prospective randomized within-subject, blinded evaluator, multicenter 
controlled study to compare the clinical performance of conventional autografting 
with and without skin cell suspension on acute nonburn full-thickness skin defects. 
 
Patients with a total body surface area (TBSA) acute skin defect up to 50% 
(inclusive) will be considered for participation in this study. An autografting plan for 
closure of the skin defect will be developed and documented in accordance with 
investigators’ standard of care. Two comparable contiguous or non-contiguous 
areas, each at least 80 cm2 in size will be identified as study treatment areas and 
labeled as Area A and Area B.  These areas will be randomly assigned to autografting 
treatment consistent with the Investigator’s pre-identified and documented autograft 
plan (Control) or to receive RECELL treatment in combination with an autograft 
meshed more widely than identified in the pre-specified autograft plan.  For example, 
if the autografting plan calls for a 2:1 meshed autograft, this will form the Control 
and will be compared to an area treated with 3:1 meshed autograft and RECELL. 
The donor site(s) for skin harvested for the RECELL and Control treatments will be 
measured (area, cm2) and documented.  The two study treatment areas will be 
compared with respect to healing characteristics, the amount of donor skin 
harvesting required and safety-related adverse events. 
 
Treatment-area healing will be evaluated via direct visualization by the treating 
investigator (unblinded) and by a qualified clinical study team member blinded to 

treatment allocation (i.e., Blinded Evaluator). The blinded assessment will serve as 
the primary healing assessment.   
 
Donor expansion associated with treatments, and incidence of healing, will be 
evaluated 8 weeks after treatment for the purposes of a regulatory application (PMA 
supplement) for market approval of RECELL for this clinical indication. During the 
regulatory phase of the study, there will be follow-up visits at 1, 2, 4, 6, 8, 10, 12 
and 26 weeks to evaluate the safety and effectiveness of RECELL for this indication, 
with durability confirmed at Week 26. Treatment-related and serious adverse events 
will be reported through Week 26. Participants will be seen for longer-term follow 
up at Weeks 36 and 52 to collect additional longer-term outcome data for 
publication.  
 
During the early assessments, the preferred method is in-person clinical visits, 
however (if necessary), the follow-up visits may be conducted remotely (e.g., via 
telemedicine) with the exception of Week 8 and the confirmation of healing visit. 
 
At all visits, subjects’ study treatment areas will be documented photographically 
using standardized digital photography.  Scar outcomes will be evaluated using the 
Patient and Observer Scar Assessment Scale (POSAS) questionnaire, which includes 
components for both the Blinded Evaluator and the subject. Subjects will be asked 
which treatment area they are more satisfied with (prior to unblinding), and then after 
unblinding, they will be told how much donor skin was associated with each 
treatment and the question of treatment preference will be asked again. 
 
Data from this clinical investigation will be summarized in a Clinical Study Report 
(CSR) and presented to the Food and Drug Administration (FDA) once all subjects 
have completed their Week 26 visit. All available data, including Week 52, for 
subjects who have completed the study at that time will be included in the report. 
The CSR will be amended once all subjects have completed the study 
Co-primary 
Effectiveness 
Endpoints 
x 
Healing at (or prior to) 8 weeks post-treatment.  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. 
x 
Ratio of actual expansion ratios. The 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. 
Safety Evaluations 
Safety will be evaluated in terms of long-term durability, scar outcomes and 
treatment-related adverse events. 
 
Safety variables that will be compared between the two treatments are: 
1. Delayed healing/non-healing 
2. Infection 
3. Allergic response to trypsin 
4. Treatment area durability  
5. Scar outcomes for which surgical intervention is determined to be medically 
necessary 
6. Pain 
7. Treatment-related and serious adverse events 

Additional Data 
Collection 
1. Investigator’s (unblinded) assessment of healing at study treatment areas and 
donor site(s) 
2. Scar outcomes reported by the Blinded Evaluator and patient (blinded) using the 
POSAS. 
3. Effectiveness of treatment blinding for the Blinded Evaluator at Week 8. 
4. Effectiveness of treatment blinding for the subject at Week 26. 
5. Subject (or parent/guardian) treatment preference at Week 52. 
6. Investigator treatment preference at Week 52. 
Inclusion Criteria 
Subjects must meet all the following criteria to be eligible for participation: 
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% TBSA. 
3. Two comparable areas requiring autografting, each at least 80 cm2 (or 160 
cm2 contiguous), excluding face and genitalia.  When hands, feet 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/foot. 
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 (or parent/guardian) agrees to abstain from any other treatment 
of the study areas for the duration of his/her participation in 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 in the study (1 year). 
8. In the opinion of the investigator, the patient and/or guardian must be able 
to: 
a) Understand the full nature and purpose of the study, including possible 
risks and adverse events, 
b) Understand instructions, and  
c) Provide voluntary written informed consent. 
Exclusion Criteria 
Subjects who meet any of the following criteria are not eligible for participation: 
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-specific procedure 
highlights 
x The study treatment areas will be prepared using standard surgical techniques. 
x The surgeon will identify and document an autografting plan for areas to be 
autografted [i.e., identifying areas to receive sheet graft, minimally perforated 
graft, and meshed graft (1:1, 2:1, 3:1)].  
x Subsequent to development of the autografting plan, two comparable treatment 
areas (with similar plans) will be identified as study treatment areas A and B by 
either bisecting one contiguous area or identifying two similar non-contiguous 
areas and photographed after appropriate demarcation with a surgical marker. 
x The randomization envelope is opened to identify which area (A or B) is Control 
and which is RECELL. 
x The autografting plan is followed as originally documented for the area assigned 
to Control 
x The originally documented autografting plan is amended as follows for the area 
assigned to RECELL: 
 Sheet, minimally perforated or 1:1 will instead be 2:1 mesh and 
RECELL 
 2:1 mesh will instead be 3:1 mesh and RECELL 
 3:1 mesh will instead be 4:1 mesh and RECELL 
x Donor site(s) for skin allocated to RECELL and Control study treatment areas 
will be measured (area, cm2) and documented. 
Statistical Considerations 
The sample size was determined so as to provide at least 80% probability that both 
co-primary endpoints will be met. Primary effectiveness will be assessed on the 
following two analysis sets: Intent to treat population (ITT) – All those enrolled into 
the study who are randomized; and Per protocol population (PP) – ITT subjects who 
receive both study treatments and have no major protocol deviations.  
 
The hypotheses to be tested for the co-primary endpoint of Confirmed Healing is the 
proportion of RECELLtreated autograft area healed prior to or at the 8-week visit is 
non-inferior to the standard of care Control treated graft area. 
 
For the co-primary effectiveness endpoint for confirmed treatment area closure, the 
hypothesis test of non-inferiority will be one-sided with a 2.5% significance level; 
for the endpoint of relative reduction in donor site area, the hypothesis test of 
superiority will be one-sided with a 2.5% significance level, all other statistical tests 
will be two-sided at the 5% significance level, unless otherwise noted. 
 
An unblinded conditional power calculation and sample size re-estimation will be 
conducted once approximately 50% of total enrollment has been evaluated for the 
primary effectiveness endpoint; i.e., 33 subjects have been randomized and reached 
the Week 8 visit (or healing confirmatory visit) or would have reached the Week 8 
visit had they not prematurely withdrawn. 
 
To account for missing data and/or loss of subjects from the PP analysis population, 
the sample size was increased to 65 patients which represents an attrition rate of 
approximately 10%.