CONTINUED ACCESS PROTOCOL: 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
Phase: NA
Conditions: Burns
Sponsor: Avita Medical

 
 
 
 
 
 
CONTINUED ACCESS PROTOCOL: 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 
 
Investigational Plan 
Study Number: 
CTP001-7 
Device: 
ReCell Autologous Cell Harvesting Device 
 
Study Type: 
IDE Study (IDE 13053) 
Date: 
August 25, 2016 
Sponsor: 
Avita Medical Americas, LLC 
9221 Corbin Ave 
Suite 220 
Northridge, CA 91324-2494 
 
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 on the date of 
 
. 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). 
Signature:   
 
Principal Investigator 
Date:  
 

 
 
PROTOCOL SYNOPSIS  
 
Title 
CONTINUED ACCESS PROTOCOL: 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 
Purpose 
The overall purpose of this is study to provide continued access to the ReCell 
device following completion of protocol CTP001-6, and to allow for collection of 
supplementary clinical outcome data for the ReCell device when used as an 
adjunct to meshed grafts in subjects with acute thermal burn injuries requiring skin 
grafting for closure of burn injuries 
Design 
This is a prospective, randomized, multicenter, evaluator blinded, within-subject 
controlled study. Patients 5 years or older with a total body surface area (TBSA) 
thermal burn injury between 5 and 50% (inclusive) will be considered for 
participation in this study. Following burn excision and confirmation of eligibility, 
a grafting plan will be developed and documented in accordance with 
investigators’ standard of care. Among the excision sites, two comparable 
contiguous or non-contiguous areas (i.e., similar in burn injury depth, graft plan 
and size) at least 300 cm2 in size will be identified and labeled as Area A and Area 
B. The wound regions will be randomly assigned to receive grafting consistent 
with the Investigator’s pre-identified graft plan (control) or to receive application 
of the ReCell- generated cell suspension applied over a graft more widely meshed 
than identified in the pre-specified graft plan (ReCell-treated). For example, if the 
graft plan called for a 2:1 mesh graft, for the ReCell-treated wounds, the area will 
be treated with 3:1 mesh graft and over-sprayed with the ReCell-generated cell 
suspension. The donor area for skin allocated to ReCell and control treatment areas 
will be measured and documented. The two treatment areas will be compared with 
respect to healing characteristics and the amount of donor skin harvesting required. 
Follow-up visits will be performed at 1, 2, 4, 6, 8, 10, 12, 24, 36 and 52 weeks 
post treatment. Acute healing and pain outcomes will be evaluated in the early 
post-operative period (i.e., through 12 weeks). Pain, healing durability and scar 
outcomes will be evaluated in the longer-term follow-up visits (i.e., 24, 36 and 52 
week visits). Treatment-related and serious adverse events will be captured 
throughout the duration of the study. 
Treatment-area closure will be evaluated via direct visualization by the treating 
investigator and by a qualified clinical investigator blinded to treatment allocation 
(i.e., Blinded Evaluator). The blinded assessment will serve as the primary healing 
assessment. 
At all visits, all subjects’ study treatment areas will be documented 
photographically using standardized digital photography. Scar outcomes will be 
measured using the Patient and Observer Scar Assessment Scale (POSAS) 
questionnaire which includes components for both the Blinded Evaluator and the 
patient. 

 
 
Co-Primary 
Effectiveness 
Endpoints 
1.Confirmed treatment area closure at (or prior to) the Week 8 visit. Complete 
wound closure is defined as skin re-epithelialization without drainage, confirmed 
at two consecutive study visits at least 2 weeks apart by direct visualization by a 
qualified clinician. Blinded Evaluator assessment of wound closure will be 
performed at Weeks 4, 6, 8, 10 and 12. 
2.The actual expansion ratios (treatment area to donor site area, inclusive of donor 
skin needed for secondary treatments) will be calculated separately for the ReCell 
and control treatments. 
Treatment area and donor area will be based on measurements of the treatment 
and donor site wound bed at the time of the grafting procedure (obtained intra-
operatively). Calculation of expansion ratios will include any donor skin required 
for re-treatments performed to achieve wound closure, if applicable. 
Additional 
Effectiveness 
Endpoints 
The following additional effectiveness endpoints will be investigated: Subject 
Satisfaction at Week 24 (evaluating whether there is a preference for the ReCell 
treatment), 24 Week Observer POSAS Overall Opinion Score and 24 Week 
Patient POSAS Overall Opinion Score 
Safety  
Safety will be assessed with evaluation of the following: 
1. Delayed healing (all visits) 
2. Infection (all visits) 
3. Allergic response to trypsin (all visits) 
4. Treatment area durability, in terms of any evidence of recurrent wound 
breakdown following initial complete closure (Week 12, 24, 36 and 52) 
5. Scars necessitating surgical intervention 
6. Treatment-area pain via numeric rating scale (1-10, where 1 represents no 
pain and 10 represents worst possible pain) will be evaluated at all visits, 
and incorporated as a component of the POSAS beginning at Week 12 
7. Treatment-related and serious adverse events (all visits) 
Other 
Evaluations 
1. Healing assessment by treating investigator (all visits) 
2. POSAS and Subject Satisfaction evaluations at Week 12, 36 and 52 
3. Subject and Blinded Evaluator blinding effectiveness 
Enrollment 
Up to 60 patients enrolled at up to 18 investigational sites in the United States 
Analysis  
Data will be analyzed and summarized in an interim analysis at a time to coincide 
with the submission of the ReCell marketing application. At that time all 
available data will be presented. Data will be analyzed consistent with the 
statistical plan develop for the CTP001-6 protocol; however, there are no formal 
statistical hypotheses to be investigated. 

 
 
Statistical 
Consideration  
It is anticipated that up to 60 subjects may be accrued in the period between the time 
the protocol is approved and receipt of FDA marketing approval for the ReCell 
device. 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.  
For the co-primary effectiveness endpoint for confirmed treatment area closure, 
the hypothesis test of non-inferiority will be one-sided with a 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. 
Data will be analyzed and summarized in an interim analysis at a time to coincide 
with the submission of the ReCell marketing application. 
For evaluation of the co-primary effectiveness endpoints, it is anticipated that there 
will be minimal missing data. However, multiple imputation and sensitivity 
analyses (e.g., pattern mixture models) will be performed if appropriate to account 
for missing data.