Continued Access Protocol: A Prospective, Multicenter, Single-Arm, Observational Study of the Safety and Clinical Performance of RES (Regenerative Epithelial Suspension) Prepared With the ReCell® Device Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries
Conditions: Burns
Sponsor: Avita Medical

 
 
 
 
 
 
 
CONTINUED ACCESS PROTOCOL 
 A Prospective, Multicenter, Single-Arm, Observational Study of the 
Safety and Clinical Performance of RES (Regenerative Epithelial 
Suspension) Prepared with the ReCell® Device Combined with 
Meshed Skin Graft in the Treatment of Acute Burn Injuries 
 
Investigational Plan 
Study Number:  
 
CTP001-8 
Device:  
 
 
ReCell Autologous Cell Harvesting Device 
 
Study Type: 
 
IDE Study (IDE 13053) 
Date: 
 
December 19, 2017 
Sponsor:  
 
 
Avita Medical Americas, LLC 
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 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: ____________________________________ 
Date: _______________ 
 
                 Principal Investigator                   

 
 
 
 
PROTOCOL SYNOPSIS 
Title: 
CONTINUED ACCESS PROTOCOL 
A Prospective, Multicenter, Single-Arm, Observational Study of the Safety and 
Clinical Performance of RES (Regenerative Epithelial Suspension) Prepared with 
the ReCell® Device Combined with Meshed Skin Graft in the Treatment of Acute 
Burn Injuries 
Purpose: 
This Continued Access Protocol has been written to allow ongoing treatment of 
subjects at selected investigational sites while the marketing application for the 
ReCell® Autologous Cell Harvesting Device is under FDA review.  
Data collected within this study will augment safety and effectiveness results from 
previous Investigational Device Exemption (IDE) studies using the ReCell® 
device, increasing the available clinical evidence for the application of RES 
(Regenerative Epithelial Suspension) prepared from the ReCell® device as an 
adjunct to meshed grafts in subjects with acute thermal burn injuries requiring 
skin grafting for closure.   
Design: 
This is a prospective, multicenter, single-arm observational study. Patients 5 years 
or older with a total body surface area (TBSA) thermal burn injury between 5 and 
50% (inclusive) who require autografting will be considered for participation in 
this study. The regenerative epithelial suspension (RES) prepared using the 
ReCell® device will be applied over skin grafts meshed more widely than 
conventional autografting. RES may also be applied to donor areas.  Healing, scar 
outcomes, pain and treatment-related adverse events will be evaluated at follow-
up visits. Data concerning the clinical performance and safety of the ReCell 
device will be collected.  
Follow-up visits will be performed at 1, 2, 4, 8, 12, and 24 weeks post-treatment.  
Healing outcomes will be evaluated at all visits by direct visualization by the 
investigator. Scar outcomes will be evaluated at 12 and 24 weeks post-treatment 
using the Patient and Observer Scar Assessment Scale (POSAS) questionnaire.  
Treatment-related and serious adverse events will be captured throughout the 
study. 
At all visits, the study treatment area and RES-treated donor area will be 
documented photographically. 
Safety 
Outcomes: 
Safety will be assessed by evaluation of treatment-related and serious adverse 
events. 
Clinical  
Performance  
Outcomes: 
Healing 
Treatment and RES-treated donor area closure will be evaluated via direct 
visualization. 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 the investigator.   

 
 
 
 
Scar 
Scar outcomes will be measured using the Patient and Observer Scar Assessment 
Scale (POSAS) questionnaire which includes a component for both investigator 
and patient scar assessment.  
Treatment-area Pain 
Measured via a numeric scale (1-10) and then as a component of the POSAS 
beginning at Week 12. 
Enrollment 
Up to 60 patients may be enrolled at up to 15 investigational sites in the United 
States. 
Statistical 
Consideration  
A sample size of 60 subjects will allow for continued access of the ReCell device 
during PMA preparation and FDA review.  Additionally, a sample size of 60 
subjects will allow for the detection of an adverse event with true probability of 
occurrence among RES-treated subjects of ≥5% with 95% probability, allowing 
for additional characterization of safety profile of the ReCell device.  
Analyses of treatment area closure will be performed for the As Treated (AT) and 
Per Protocol (PP) populations. Data will be summarized using counts and 
percentages for healed/not healed, and an exact (Clopper-Pearson) two-sided 95% 
confidence interval for the true proportion will be presented. 
The AT population includes all those enrolled into the study and treated with RES.  
The AT population will be the primary analysis population for the healing, 
POSAS and pain assessments. 
The PP population includes all AT subjects who have no major protocol 
deviations. The PP population will serve as the secondary analysis population for 
the healing, POSAS and pain assessments. 
For evaluation of healing, scars, and pain, it is anticipated that there will be 
minimal missing data. No imputation of missing data is planned.