A Phase 3 Multicenter, Single-Arm, Open-Label Study Evaluating the Safety, Tolerability and Efficacy of StrataGraft® Construct in Pediatric Subjects With Deep Partial Thickness (DPT) Thermal Burns
Phase: PHASE3
Conditions: Skin Wound, Burns, Trauma-related Wound
Sponsor: Stratatech, a Mallinckrodt Company

Official Title:  A Phase 3 Multicenter, Single-Arm, Open-Label Study Evaluating 
the Safety, Tolerability and Efficacy of StrataGraft® Construct in Pediatric 
Subjects with Deep Partial Thickness (DPT) Thermal Burns
NCT Number: NCT05517902
Document, Version and Date: Protocol, Version 3.0, 26 September 2023

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STRATAGRAFT® 
(ALLOGENEIC CULTURED KERATINOCYTES AND DERMAL FIBROBLASTS IN 
MURINE COLLAGEN-DSAT) 
PROTOCOL NUMBER: 
MNK15011001 
PROTOCOL NAME:  
 A Phase 3 Multicenter, Single-Arm, Open-Label Study 
Evaluating the Safety, Tolerability and Efficacy of StrataGraft®
Construct in Pediatric Subjects with Deep Partial Thickness 
(DPT) Thermal Burns 
VERSION NUMBER/DATE:  Version 3, dated 26 Sep 2023 
SHORT TITLE: 
 StrataSTEPS (StrataGraft Safety, Tolerability and Efficacy in 
Pediatric Subjects) 
SPONSOR NAME  
Stratatech Corporation, a Mallinckrodt Company 
REGISTERED   
510 Charmany Drive, Suite 150 
ADDRESS:   
Madison, WI 53719 
US FDA IND Number: 
010,113 
This document is a confidential communication of Stratatech Corporation, a Mallinckrodt 
Company. Acceptance of this document constitutes the agreement by the recipient that no 
unpublished information contained herein will be published or disclosed without the prior written 
approval of Mallinckrodt, except that this document may be disclosed to appropriate health 
authorities and institutional review boards/ethics committees so long as they are requested to 
maintain its confidentiality. 

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SIGNATURE PAGE 
Sponsor’s Approval 
My signature, in conjunction with the signature of the investigator, confirms the agreement of 
both parties that the clinical study will be conducted in accordance with the protocol and 
applicable laws and other regulations including, but not limited to, the International Council for 
Harmonisation (ICH) Guideline for Good Clinical Practice (GCP), the US Code of Federal 
Regulations (CFR) (where applicable), all applicable national and local regulations, protections 
for privacy, and generally accepted ethical principles for human research such as the Declaration 
of Helsinki. 
Nothing in this document is intended to limit the authority of a physician to provide emergency 
medical care. 
Responsible Medical Officer: 
   Refer to e-signature page 
 
Date 

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ACKNOWLEDGEMENT OF RECEIPT AND UNDERSTANDING OF 
SPONSOR STUDY MATERIALS 
 
My signature confirms that the clinical study will be conducted in accordance with the protocol 
and applicable laws and other regulations including, but not limited to, the International Council 
for Harmonisation (ICH) Guideline for Good Clinical Practice (GCP), the US Code of Federal 
Regulations (CFR), protections for privacy, and generally accepted ethical principles such as the 
Declaration of Helsinki. 
 
Nothing in this document is intended to limit the authority of a physician to provide emergency 
medical care. 
 
I confirm that I have received, read, and understood the following document(s) for: 
 
PRODUCT:  
StrataGraft®  
 
STUDY: 
StrataSTEPS - Protocol MNK15011001 
 
 
PRINCIPAL/COORDINATING INVESTIGATOR(S) 
 
Name: 
Title: 
Date: 
 
 
   Refer to e-signature page 
Name 
 
Date 

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SUMMARY OF CHANGES FOR AMENDMENTS 
Version 3 includes changes related to modifications in the xenotransplantation product 
requirements and prohibitions, which are reflected in Sections 4.4 and 11.9.1.5. Administrative 
issues and clarifications show changes in Section 1 (Synopsis) and Sections 6.1, 6.8, 8.2, 9.3, and 
11. Appendix 6 is a table of the summary of changes. 
 

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1. 
SYNOPSIS 
Name of Sponsor/Company: Stratatech Corporation, a Mallinckrodt Company 
Name of Investigational Product: StrataGraft® Construct 
Name of Active Ingredient: StrataGraft is a viable and metabolically active allogeneic human NIKS 
keratinocytes and human dermal fibroblasts cellularized layered scaffold.  
Protocol Number: MNK15011001 
Phase: 3 
Country: US 
Title of Study: A Phase 3 Multicenter, Single Arm, Open-label Study Evaluating the Safety, 
Tolerability and Efficacy of StrataGraft® Construct in Pediatric Subjects with Deep Partial-Thickness 
(DPT) Thermal Burns 
Study center(s): Approximately 10 sites 
Objectives:  
Primary: To evaluate whether StrataGraft treatment promotes wound closure and reduces or 
eliminates the need for donor site harvest and autografting in a pediatric population with thermal 
burns that contain intact dermal elements and for which autografting would be part of standard of 
care (deep partial-thickness [DPT] burns). 
Study Design: This is a prospective, open-label, single -arm, age-stratified study to examine the 
safety and efficacy of StrataGraft construct in the treatment of pediatric subjects with thermal burns 
that contain intact dermal elements and for which autografting would be part of standard of care (deep 
partial-thickness [DPT] burns). This study is designed to assess the safety and efficacy of StrataGraft 
in the treatment of DPT thermal burns, defined as those that contain intact dermal elements and for 
which excision/debridement and autografting are clinically indicated. 
Methodology: Approximately 50 subjects will be enrolled into one of two age-based cohorts: 2 to < 
12 years (up to n = 40) and 12 to ≤ 17 years (up to n = 10). The proposed study population will 
include pediatric subjects with thermal injuries covering no more than 30% of their total body surface 
area (TBSA) with at least 0.5% TBSA DPT thermal burn. Each subject must also have a sufficient 
area of healthy skin available for use as a donor site in the event that autografting is clinically 
necessary. Study assessments will include the incidence of adverse events (AEs), including wound 
infection, and additionally monitoring of vital signs, clinical laboratory values, immunological values 
(where possible), wound closure, including any autografting, and skin quality of the treatment site.  
Number of patients (planned): Approximately 50 subjects are planned to be enrolled. 

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Main criteria for inclusion: An included subject will be or have: 
1. Aged 2 through 17 years, inclusive, at the time of consent 
2. Written informed consent from parent(s) or legal guardian(s) and assent from the child when 
appropriate, as determined by the Institutional Review Board (IRB), consistent with 
regulatory criteria and requirements. 
3. Sufficient healthy skin available and reserved as a donor site in the event that the StrataGraft 
treatment site requires autografting. 
4. Thermal burns of no more than a total of 30% TBSA.  
5. Consenting adult(s) is/are able and willing to attend/bring child to the scheduled visits and 
comply with study procedures. 
6. Study treatment sites that are DPT in depth (ie, containing dermal elements) and for which 
excision and autografting are clinically indicated as assessed by the investigator, and located 
on the torso or extremities. 
7. Study treatment area(s) totaling 0.5% to 10% TBSA and may be composed of up to 3 non-
contiguous areas located on the same extremity or plane of the torso. 
Main criteria for exclusion: Subjects may not be or have:  
1. Receiving systemic immunosuppressive therapy and/or systemic corticosteroids (inhaled 
corticosteroids are permitted).  
2. Concurrent trauma, conditions, and/or personal situations that, in the opinion of the 
investigator, may compromise subject safety or the study objectives. 
3. A burn injury that occurred ≥ 14 days prior to planned StrataGraft application. 
4. A proposed study treatment site that has been previously excised or autografted; located 
adjacent to an undebrided/unexcised burn area; demonstrates signs and symptoms of wound 
infection, per judgement of the clinical investigator; lies across joints or is located on the feet 
(ie, distal to the malleolus), hands (distal to the wrist), face, neck, buttocks, perineum, or 
genitalia. 
Investigational product, dosage and mode of administration: The investigational product is 
StrataGraft® Construct, a rectangular cellularized sheet approximately 100 cm2, applied topically by 
the investigator following excision/debridement of the treatment site. 
Duration of treatment: Following a screening period of up to 14 days following burn injury, 
qualified subjects will be enrolled and receive a single application of StrataGraft to 0.5% to 10% 
TBSA following debridement of non-viable tissue. Subjects will return to the clinic for visits weekly 
until confirmation of complete wound closure. Follow-up visits will be conducted at Week 12 and 
Months 6 and 12. Subjects will participate in the study for approximately 13 months, not including 
the screening period of up to 14 days. 
Reference therapy, dosage and mode of administration: Not applicable. 
Criteria for evaluation: 
Primary efficacy endpoint: Percentage of subjects achieving confirmed complete closure of 
StrataGraft treatment sites on or before Week 12 without autograft placement. Confirmed complete 
wound closure is defined as complete skin re-epithelialization confirmed at 2 consecutive visits at 
least 2 weeks apart, but no later than Week 20. 

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Secondary ranked efficacy endpoints: 
1. Mean of averaged  percent area of StrataGraft treatment sites per subject closed at Week 12 
without autograft placement 
2. Number (%) of StrataGraft treatment sites with confirmed complete wound closure without 
autograft placement on or before Week 12  
3. Mean of averaged percent area of StrataGraft treatment sites autografted per subject by Week 
12 
Exploratory endpoints and assessments: 
• 
Mean percent area of StrataGraft treatment site closed without autograft placement at Week 8 
• 
Mean Patient and Observer Scar Assessment Scale (POSAS) observer total score at Week 12, 
and Months 6 and 12. 
• 
Changes in skin quality outcome (POSAS and Patient Scar Assessment Questionnaire 
[PSAQ] scores) across time. 
• 
Incidence and severity of pain at the treatment site using EVENDOL (Evaluation Enfant 
Douleur, ie, Evaluation of Child Pain; observer or parent) or FPRS (Wong-Baker Faces Pain 
Rating Scale with 6 faces with expressions denoting degrees of pain; subject) over time. 
• 
Percent of subjects with complete closure of StrataGraft treatment site without autografting at 
Weeks 6 and 8 and Months 6 and 12.  
• 
Time to complete closure following application of StrataGraft.  
• 
Mean percent wound closure over time from Day 21 through Month 12. 
• 
Percent of subjects achieving and maintaining persistent wound closure at Months 6 and 12. 
• 
Mean scar satisfaction based on PSAQ scores at Week 12 and Months 6 and 12. 
Safety: The assessment of subject safety will consist of monitoring treatment-emergent adverse 
events, adverse events of special interest, serious adverse events, vital signs, and wound-related 
adverse events, including infection, throughout the study duration. These data will be episodically 
reviewed by a Data Monitoring Committee (DMC). Safety laboratory values (complete blood count 
with differential and comprehensive metabolic panel) will be measured along with panel reactive 
antibodies (PRA) and anti-bovine serum albumin (BSA) antibodies. 
Statistical Overview: This pediatric study plans to enroll up to 50 subjects into one of two age 
cohorts: 2 to < 12 years (up to n = 40) and 12 to ≤ 17 years (up to n = 10). Analyses will be performed 
as the overall population. Analyses by age cohort will also be performed. 
For the primary endpoint, number (%) and 95% confidence interval (CI) will be summarized based on 
the Intent-to-Treat population. Subjects with missing data will be imputed as nonresponders. The 
summary will also be performed based on all observed data, ie, excluding any missing data. 
After the primary endpoint is successfully achieved, the ranked secondary efficacy endpoints will 
each be tested in a hierarchical manner in their ranked order, using a 2-sided confidence interval with 
0.05 Type I error .  
• 
The averaged percent area closed per subject will be calculated as, “Sum of percent area 
closed across treatment sites for a subject/the number of treatment sites on that subject” 
• 
The percentage of StrataGraft treatment sites with confirmed complete wound closure 
without autograft placement on or before Week 12 will be calculated as [(Total number of 
StrataGraft treatment sites with confirmed complete wound closure without autografting on 
or before Week 12/Total number of treatment sites) x 100]  

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• 
The averaged percent area of StrataGraft treatment site per subject autografted by Week 12 
will be calculated as (Sum of averaged percent area of StrataGraft treatment sites autografted 
for a subject/the number of StrataGraft treatment sites on a subject). It is a cumulative sum of 
percent area autografted for all nonmissing visits on or before Week 12.  
For continuous efficacy endpoints, missing data will not be imputed. Missing or incomplete binary 
variables will be imputed as failures. 

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2. 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF 
FIGURES  
TABLE OF CONTENTS 
TITLE 
1 
SIGNATURE PAGE .......................................................................................................................2 
ACKNOWLEDGEMENT OF RECEIPT AND UNDERSTANDING OF SPONSOR 
STUDY MATERIALS .................................................................................................3 
SUMMARY OF CHANGES FOR AMENDMENTS .....................................................................4 
1. 
SYNOPSIS ...................................................................................................................5 
2. 
TABLE OF CONTENTS, LIST OF TABLES, AND LIST OF FIGURES .................9 
3. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS .............................14 
4. 
INTRODUCTION ......................................................................................................16 
4.1. 
Background .................................................................................................................16 
4.2. 
Study Rationale ...........................................................................................................17 
4.3. 
Assessment of Potential Risks and Benefits ...............................................................18 
4.4. 
Xenotransplantation Considerations ...........................................................................18 
5. 
OBJECTIVES AND ENDPOINTS ............................................................................19 
5.1. 
Primary Objective and Endpoint ................................................................................19 
5.1.1. 
Primary Efficacy Objective ........................................................................................19 
5.1.2. 
Primary Efficacy Endpoint .........................................................................................19 
5.1.3. 
Primary Outcome Measures: ......................................................................................19 
5.2. 
Secondary Efficacy Endpoints ....................................................................................19 
5.3. 
Exploratory Endpoints and Assessments ....................................................................19 
5.4. 
Safety Endpoints and Assessments .............................................................................20 
6. 
INVESTIGATIONAL PLAN .....................................................................................21 
6.1. 
Overall Study Design ..................................................................................................21 
6.2. 
Study Design Rationale ..............................................................................................22 
6.3. 
Treatment Rationale ....................................................................................................22 
6.4. 
Study Stopping Rules .................................................................................................22 
6.5. 
End of Study Definition ..............................................................................................23 
6.6. 
Discontinuation of Study Treatment ...........................................................................23 
6.7. 
Subject Discontinuation/Withdrawal from the Study .................................................23 
6.8. 
Schedule of Study Events and Assessments ...............................................................24 

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7. 
SELECTION AND WITHDRAWAL OF SUBJECTS ..............................................27 
7.1. 
Subject Inclusion Criteria ...........................................................................................27 
7.2. 
Subject Exclusion Criteria ..........................................................................................27 
7.3. 
Screen Failures ............................................................................................................28 
8. 
TREATMENT OF SUBJECTS ..................................................................................29 
8.1. 
Treatment Administration ...........................................................................................29 
8.1.1. 
Study Enrollment ........................................................................................................29 
8.1.2. 
Burn Wound ................................................................................................................29 
8.2. 
Prior and Concomitant Medications/Therapies ..........................................................30 
8.2.1. 
Permitted Concomitant Therapies ..............................................................................30 
8.2.2. 
Prohibited Therapies ...................................................................................................30 
8.3. 
Study Treatment Compliance .....................................................................................30 
8.4. 
Randomization and Blinding ......................................................................................31 
9. 
INVESTIGATIONAL PRODUCT MATERIALS AND MANAGEMENT .............32 
9.1. 
Investigational Product ...............................................................................................32 
9.2. 
Investigational Product Packaging and Labeling .......................................................32 
9.3. 
Investigational Product Receipt and Storage ..............................................................32 
9.4. 
Investigational Product Preparation and Administration ............................................32 
9.5. 
Investigational Product Accountability ......................................................................32 
9.6. 
Investigational Product Handling and Disposal .........................................................32 
10. 
SCHEDULE OF STUDY EVALUATIONS ..............................................................33 
10.1. 
Screening ....................................................................................................................33 
10.2. 
Treatment Day 1 (Day of Excision/Debridement and Investigational Product 
Application) ................................................................................................................33 
10.3. 
Treatment Days 7, 14, and 21 (± 2 days), Day 28 (± 3 days), and Weeks 5 - 
11 (± 3 days) ...............................................................................................................34 
10.4. 
Treatment Week 12 (± 1 week) and Months 6 and 12 (± 1 month) ...........................35 
11. 
STUDY ASSESSMENTS AND PROCEDURES ......................................................37 
11.1. 
Informed Consent/Assent ...........................................................................................37 
11.2. 
Screening Assessments ...............................................................................................37 
11.2.1. 
Medical History and Physical Examination ...............................................................37 
11.2.2. 
Pregnancy Test ............................................................................................................38 
11.2.3. 
Height and Body Weight ............................................................................................38 

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11.2.4. 
Vital Signs ..................................................................................................................38 
11.3. 
Study Site Assessments ..............................................................................................38 
11.3.1. 
StrataGraft Application ...............................................................................................38 
11.3.2. 
Wound Closure Assessment .......................................................................................38 
11.3.3. 
Area of the Study Sites Autografted ...........................................................................38 
11.3.4. 
Photography of Treatment Sites .................................................................................39 
11.3.5. 
Skin Quality of Treatment Sites .................................................................................39 
11.3.6. 
Other Wound Assessments .........................................................................................39 
11.4. 
Concomitant Medications and Procedures .................................................................39 
11.5. 
Safety Laboratory Tests ..............................................................................................40 
11.6. 
Immunological Assays and Archival Samples ...........................................................40 
11.7. 
Pain Assessment .........................................................................................................40 
11.8. 
Assessment of the Need for Continued Hospitalization .............................................40 
11.9. 
Adverse Events and Serious Adverse Events .............................................................41 
11.9.1. 
Definitions ..................................................................................................................41 
11.9.1.1. 
Adverse Event (AE) ....................................................................................................41 
11.9.1.2. 
Unexpected Adverse Event .........................................................................................42 
11.9.1.3. 
Treatment Emergent Adverse Events .........................................................................42 
11.9.1.4. 
Serious Adverse Event (SAE) ....................................................................................42 
11.9.1.5. 
Adverse Event of Special Interest ...............................................................................43 
11.9.2. 
Adverse Event Medical Management Plan .................................................................44 
11.10. 
Relationship to Investigational Product ......................................................................44 
11.11. 
Severity Assessment ...................................................................................................45 
11.12. 
Recording and Reporting Adverse Events ..................................................................45 
11.13. 
Pregnancy Reporting ..................................................................................................46 
12. 
STATISTICAL CONSIDERATIONS .......................................................................47 
12.1. 
Sample Size Determination ........................................................................................47 
12.2. 
Analysis Populations ..................................................................................................47 
12.3. 
Statistical Analyses .....................................................................................................47 
12.3.1. 
Efficacy Analyses .......................................................................................................47 
12.3.1.1. 
Primary Endpoint ........................................................................................................47 
12.3.1.2. 
Ranked Secondary Endpoints .....................................................................................48 

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12.3.1.3. 
Binary Endpoints ........................................................................................................49 
12.3.1.4. 
Exploratory Endpoints ................................................................................................49 
12.3.2. 
Safety Analyses ..........................................................................................................53 
12.3.3. 
Handling of Missing Data ...........................................................................................53 
13. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS ..................................................................................................54 
13.1. 
Institutional Review Board (IRB) ...............................................................................54 
13.2. 
Financial Disclosure ...................................................................................................54 
13.3. 
Subject Information and Consent ...............................................................................54 
13.4. 
Master Identification List ...........................................................................................55 
13.5. 
Data Protection ...........................................................................................................55 
13.6. 
Committees Structure .................................................................................................55 
13.7. 
Dissemination of Clinical Study Data ........................................................................56 
13.8. 
Data Quality Assurance ..............................................................................................56 
13.9. 
Source Documents ......................................................................................................56 
13.10. 
Study and Site Closure ................................................................................................57 
14. 
REFERENCES ...........................................................................................................58 
APPENDIX 1.  CLINICAL LABORATORY TESTS ...............................................................60 
APPENDIX 2.  STUDY GOVERNANCE CONSIDERATIONS .............................................61 
APPENDIX 3.  CONTRACEPTIVE GUIDANCE AND COLLECTION OF   
PREGNANCY INFORMATION ...............................................................................65 
APPENDIX 4.  COUNTRY-SPECIFIC REQUIREMENTS .....................................................67 
APPENDIX 5.  TOOLS USED FOR ASSESSMENT DURING THE STUDY ........................68 
APPENDIX 6.  SUMMARY OF CHANGES FROM VERSION 2 TO VERSION 3 ...............70 
 
 
 
 
 
 
 

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LIST OF TABLES 
Table 1: 
Abbreviations and Specialist Terms ...........................................................................14 
Table 2: 
Schedule of Study Events and Assessments ...............................................................24 
Table 3: 
Investigational Product ...............................................................................................29 
Table 4: 
Adverse Event Relationships ......................................................................................44 
Table 5: 
Adverse Event Intensity Grades .................................................................................45 
Table 6: 
Reporting Requirements for Adverse Events .............................................................46 
Table 7: 
The Objective, Population, Hypothesis, Endpoint and Intercurrent Events 
and Data Handling for the Primary Endpoint .............................................................50 
Table 8: 
The Objective, Population, Hypotheses, Endpoints and Intercurrent Events 
and Data Handling for Ranked Secondary Efficacy Endpoints ..................................51 
 
LIST OF FIGURES 
Figure 1: 
Number and Etiology of Burns by Age ......................................................................16 
 
 
 

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3. 
LIST OF ABBREVIATIONS AND DEFINITIONS OF TERMS 
The following abbreviations and specialist terms are used in this study protocol. 
Table 1: 
Abbreviations and Specialist Terms  
Abbreviation 
Explanation 
AE 
Adverse event 
AESI 
Adverse Event of Special Interest 
BSA 
Bovine serum albumin 
CBC 
Complete blood count 
CFR 
Code of Federal Regulations 
CI 
Confidence Interval 
CMP 
Comprehensive metabolic panel 
Complete closure 
Complete re-epithelialization without drainage 
Confirmed complete 
closure 
Complete wound closure confirmed at 2 consecutive visits at 
least 2 weeks apart but no later than Week 20  
DPT 
Deep partial thickness, defined as a wound extending into the 
dermis but that contains intact dermal elements and for which 
excision/debridement and autografting are clinically indicated 
DMC 
Data Monitoring Committee 
eCRF 
Electronic case report form 
EVENDOL 
EValuation ENfant DOuLeur, ie, Evaluation of Child Pain, a 
validated scale used to measure pain in pre-verbal children by 
assessing behavioral cues 
FPRS 
Wong–Baker Faces Pain Rating Scale, a validated scale of 6 
faces with expressions denoting degrees of pain  
FDA 
US Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
ICC 
Intraclass correlation coefficient 
ICF 
Informed consent form 
ICH 
International Council for Harmonisation 
IEC 
Independent Ethics Committee 
IP 
Investigational Product 
IRB 
Institutional review board 
ITT 
Intent-to-treat 
LB 
Lower Bound 
Persistence of Closure 
Maintenance of wound closure for at least 3 months after 
confirmation of complete wound closure. 
POSAS 
Patient and observer scar assessment scale 
PRA 
Panel reactive antibodies 

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PSAQ 
Patient Scar Assessment Questionnaire 
SAE 
Serious adverse event 
SAP 
Statistical Analysis Plan 
StrataSTEPS 
StrataGraft Safety, Tolerability and Efficacy in Pediatric 
Subjects 
TBSA 
Total body surface area 
TEAE 
Treatment emergent adverse event 

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4. 
INTRODUCTION 
4.1. 
Background 
Burn-related injuries are a leading cause of morbidity and mortality in children. Nearly a quarter 
of all burn injuries occur in children under the age of 16 years, most in children under the age of 
5 years (Krishnamoorthy, 2012; Kramer, 2010). Every day in the United States, more than 
300 children (age from 0 to 19 years) are treated for burn injuries in emergency departments, and 
2 children die as a consequence of their burn injury (Borse, 2008). Approximately 90% of 
pediatric burns are caused by household accidents, with scald burns being most common 
amongst younger children and flame burns most common in the older child (National Burn 
Repository, 2019). Further, far more children under the age of 12 years are burned than are 
adolescents. 
Figure 1: 
Number and Etiology of Burns by Age 
 
Source: Figure 11, National Burn Repository, 2019. 
Although wound healing and wound management do not differ between adults and children, 
there are differences between children and adults that may significantly affect how pediatric burn 
patients are managed. Young children have nearly 3 times the surface area to body mass ratio of 
adults, so they experience greater evaporative water losses and, hence, require greater fluid 
replacement. This difference in the surface area to body mass ratio also predisposes the child to 
hypothermia and increases their thermogenic metabolic demand. Finally, because of 
disproportionately thin skin in children, a burn that may initially appear to be partial thickness 
may instead declare itself to be full thickness within a day or 2 of injury, making burn depth 
assessment difficult. 

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After stabilization of the critical care issues in the burn-injured child, attention is directed toward 
burn wound management. The ultimate aim of wound management in burns is to prevent wound 
infection and facilitate closure of the wounds, either spontaneously or by autologous skin grafts. 
Key elements of burn wound management include cleansing, debridement or surgical excision, 
topical antimicrobial agents, and dressings. 
Regardless of the age of the patient, evidence suggests that early excision of burn eschar is 
effective in decreasing morbidity, improving the mortality rate, and reducing length of stay 
(Pietsch, 1985; Muller, 1994; Herndon, 1989), as well as hospital costs (Munster, 1994). Deep 
partial thickness (DPT) burns that are expected to take longer than 3 weeks to heal and full-
thickness burns (with the exception of very small injuries) should be grafted, as this reduces 
hypertrophic scarring and results in better cosmesis (Heimbach, 1987; Chipp, 2017).  
Excised areas are usually closed with autograft or with allograft, xenograft, or other skin 
substitute until autograft is available or the wound spontaneously closes. Availability of 
autologous donor tissue, however, is limited by the extent of the burn injury. In larger injuries, 
donor sites are often harvested repeatedly, increasing the likelihood of scarring at those sites. 
Further, the simple harvest of a donor site incurs acute pain as well as the potential for infection 
and scarring. As such, methods to reduce the amount of donor tissue needed to achieve wound 
closure are always sought.  
StrataGraft is a viable, bioengineered, allogeneic, cellularized scaffold product composed of a 
differentiated epidermal compartment comprised of epidermal cells from a single human donor 
grown on a dermal equivalent composed of purified Type I animal collagen containing normal 
human fibroblasts from a second donor. The viable cells of StrataGraft produce and secrete a 
variety of growth factors, cytokines, and antimicrobial peptides. These factors are known to be 
involved in wound repair and tissue regeneration. 
4.2. 
Study Rationale 
StrataGraft is under development by Stratatech Corporation, a Mallinckrodt Company, as an 
alternative to autografting to promote the healing of acute thermal burns. A Biologics License 
Application for StrataGraft for the treatment of adults with thermal burns containing intact 
dermal elements for which surgical intervention is clinically indicated (DPT burns) has received 
Food and Drug Administration (FDA) approval. Data from a Phase 3 study in adults 
demonstrated that 83% of wounds treated with a single application of StrataGraft achieved 
durable closure at Month 3 without autografting (Holmes, 2020). For that study, durable wound 
closure was defined as closure at 2 consecutive visits at least 2 weeks, but not more than 5 
months apart and including or encompassing the Month 3 time point. Subjects with missing data 
were considered to have failed the endpoint.  
Treating DPT burns with StrataGraft rather than autografting may be particularly beneficial for 
pediatric burn patients. This study is being conducted in order to evaluate the safety and efficacy 
of StrataGraft treatment in pediatric subjects with DPT burn injuries. 

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4.3. 
Assessment of Potential Risks and Benefits 
Results to date in adults indicate that treatment with StrataGraft is well tolerated and no acute 
immune response has been reported. The most commonly reported adverse events (AEs) 
associated with StrataGraft are pruritus, blister, and hypertrophic scar.  
Subjects in this study will undergo surgical excision/debridement of nonviable tissue in the burn 
wound. The risks associated with this procedure include pain and bleeding at the surgical site as 
well as potential complications of anesthesia, such as nausea/vomiting, chills, and sore throat.  
All procedures and activities in this study, other than the actual application of StrataGraft, are 
generally accepted as standard of care for patients with thermal burns and are not considered to 
present any potential increased risk to the subjects. More detailed information about the known 
and expected benefit, risks, and reasonably expected AEs can be found in the StrataGraft 
Investigator’s Brochure. 
4.4. 
Xenotransplantation Considerations 
StrataGraft is a xenotransplantation product because in the past, one of the cell types used to 
make StrataGraft was grown with mouse cells. The cell banks have been tested and found to be 
free of detectable infectious agents and mouse cells are no longer used in the manufacture of 
StrataGraft. There have been no identified health concerns associated with these mouse cells.   
Recipients of xenotransplantation products are generally not eligible, per federal regulations, to 
donate whole blood, blood components, source plasma or source leukocytes. However, 
individual blood banks may request an exception from FDA. StrataGraft recipients wishing to 
donate blood or blood products should check with their donation center. StrataGraft recipients 
who otherwise meet the donor requirements are eligible to donate human cells, tissues, breast 
milk, ova, sperm, or body parts for transplantation. 
A small amount of blood (3 mL), called an archival sample, will be collected before StrataGraft 
application. This sample could be used as a baseline to assess health issues that may be related to 
treatment. These samples will be used only for the purpose of responding to a request from FDA. 
Both archival samples and any associated subject information will be stored and used only as 
required and allowed by law. 
 

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5. 
OBJECTIVES AND ENDPOINTS 
5.1. 
Primary Objective and Endpoint 
5.1.1. 
Primary Efficacy Objective 
To evaluate whether StrataGraft treatment eliminates or reduces the need for autografting and 
promotes wound closure in a pediatric population with thermal burns that contain intact dermal 
elements and for which autografting is clinically indicated (DPT burns). 
5.1.2. 
Primary Efficacy Endpoint 
Percentage of subjects achieving confirmed complete closure of StrataGraft treatment 
sites on or before Week 12 without autograft placement. Confirmed complete wound 
closure is defined as complete skin re-epithelialization confirmed at 2 consecutive 
visits at least 2 weeks apart but no later than Week 20. 
5.1.3. 
Primary Outcome Measures: 
• Percentage of participants achieving confirmed complete closure of StrataGraft 
treatment sites without autograft within 12 weeks of StrataGraft application, ie, 
percentage of participants whose burn healed after StrataGraft treatment without 
needing the doctor to treat the burn with skin cut from other parts of the patient’s own 
body.  
• Number of participants with treatment-emergent adverse events (TEAEs) that 
occurred between StrataGraft application and the end of the study (within 12 months 
of last data collection) and considered related to StrataGraft. This measure is not to be 
considered as a measure of study success.  
5.2. 
Secondary Efficacy Endpoints 
The secondary efficacy endpoints, in hierarchical order, are: 
1. Mean of averaged percent area of StrataGraft treatment sites per subject closed at Week 
12 without autograft placement. 
2. Number (%) of confirmed complete wound closures of the StrataGraft treatment sites on 
or before Week 12 without autograft placement. 
3. Mean of averaged percent area of StrataGraft treatment sites per subject autografted by 
Week 12. 
5.3. 
Exploratory Endpoints and Assessments 
• Mean percent area of StrataGraft treatment site closed without autograft placement at 
Week 8. 
• Mean Patient and Observer Scar Assessment Scale (POSAS) Observer total score at 
Week 12, and Months 6 and 12. 

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• Changes in skin quality outcome at StrataGraft treatment site (POSAS and Patient 
Scar Assessment Questionnaire [PSAQ] scores) across time. 
• Incidence and severity of pain at the StrataGraft treatment site using EVENDOL 
(EValuation ENfant DOuLeur, ie, Evaluation of Child Pain; observer or parent) or 
FPRS (6 faces with expressions denoting degrees of pain; subject) rating scales over 
time. 
• Percent of subjects with complete closure of StrataGraft treatment site without 
autografting at Weeks 6 and 12, and Months 6 and 12.  
• Time to complete closure following application of StrataGraft.  
• Mean percent wound closure of treated wound area over time from Day 21 through 
Month 12. 
• Percent of subjects achieving and maintaining persistent wound closure at Months 6 
and 12. 
• Mean scar satisfaction based on PSAQ scores at Week 12, and Months 6 and 12. 
5.4. 
Safety Endpoints and Assessments 
The assessment of safety of StrataGraft in pediatric subjects. 
Acceptable safety profile at Week 12 and Month 12, as determined by the Data Safety & 
Monitoring Committee (DMC; Section 13.6), with regard to: 
• TEAEs. 
• Serious adverse events (SAEs). 
• Vital signs. 
• Wound-related adverse events, including infection, throughout the study duration. 
• Safety laboratory values (complete blood count with differential and comprehensive 
metabolic panel). 
• Where practical, panel reactive antibodies (PRA) and anti-bovine serum albumin 
(BSA) antibodies.  
 

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6. 
INVESTIGATIONAL PLAN 
6.1. 
Overall Study Design 
This is a prospective, open-label, single arm study to examine the safety, tolerability and clinical 
efficacy of StrataGraft in the treatment of DPT thermal burns in pediatric subjects. The study 
population will include pediatric subjects ages 2 to 17 years, inclusive, with thermal burns that 
contain intact dermal elements and for which autografting would be part of standard of care. As 
previously discussed, far more pre-school and school-aged children are burned than adolescents. 
Qualified subjects will be enrolled into one of two age-based cohorts: 2 to < 12 years (up to 
n=40) and 12 to ≤ 17 years (up to n=10).   
Informed consent will be obtained from parents/guardians and assent from the child, when 
appropriate, as determined by the IRB and consistent with regulatory criteria and requirements 
before any protocol-related assessments or procedures are conducted. After consent is provided, 
data collected during the course of admission and routine assessment may be abstracted from the 
medical record and used for study purposes. 
Following a screening period of up to 14 days, subjects will be enrolled and receive a single 
application of StrataGraft to 0.5% to 10% total body surface area (TBSA), which may be 
composed of up to 3 non-contiguous areas located on the same extremity or plane of the torso. 
Subjects will return to for weekly visits until complete wound closure of all study treatment sites 
is confirmed. Follow-up visits will be conducted at Week 12 and Months 6 and 12. Subjects will 
participate in the study for approximately 13 months, not including the screening period of up to 
14 days. The Schedule of Study Events is provided in Table 2.  
The duration of the study from first subject first visit to last subject last visit will depend upon 
the ability of the sites to identify and enroll eligible subjects. The study is expected to enroll 
subjects over a period of 12 to 18 months. The entire study is expected to require approximately 
2.5 years to complete. 
Safety assessments will include monitoring incidence of AEs, wound-related events, vital signs, 
clinical laboratory values (where possible), immunological markers (where possible), wound 
closure, pain, and scarring. 
Subjects will undergo baseline assessments including a targeted physical examination and 
collection of clinical laboratory assessments during Screening. After enrollment and StrataGraft 
application, wound assessments, photographs, and solicitation of AEs will be performed at each 
study visit via telephone or video interaction if the subject is unable to attend the visit. However, 
wound closure may only be assessed at face-to-face visits. If not collected during Screening, 
clinical laboratory samples will be collected via venipuncture performed prior to StrataGraft 
application on Day 1. Immunological samples (monitoring of PRA and anti-BSA antibodies) will 
be collected prior to StrataGraft application, and again between Week 6 and Month 6 for all 
treated subjects. 
A subject’s study participation ends after the Month 12 visit. However, during the study period, 
should a subject return to the investigator for a follow-up visit not scheduled for the purposes of 
the study, the investigator, when feasible, will record any update on the subject’s wound status 

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and safety information and report such information to the Sponsor using the data collection 
forms provided for such an Unscheduled visit. 
6.2. 
Study Design Rationale  
Deep partial thickness and full thickness burns that are expected to take longer than 3 weeks to 
heal are usually autografted, as this reduces the incidence of hypertrophic scarring and results in 
better cosmesis (Heimbach, 1987; Chipp, 2017). Donor sites are painful and patients have 
remarked that they are more painful than the burn injury itself (Romanelli, 2019; Sinha, 2017). 
Availability of autologous donor tissue is limited by the extent of the burn injury, and in larger 
injuries, donor sites may be repeatedly harvested, increasing the likelihood of scarring at those 
sites. 
Clinical data from the STRATA2016 pivotal study of StrataGraft use for promoting the closure 
of DPT thermal burns in adult subjects demonstrated that more than 95% of subjects achieved 
closure without autografting after treatment with StrataGraft, thereby obviating the harvest of 
autograft and the pain associated with donor sites.   
6.3. 
Treatment Rationale 
StrataGraft is a viable, bioengineered, allogeneic, cellularized scaffold product that is anticipated 
to provide immediate wound coverage, aid in wound bed conditioning, and promote autologous 
tissue regeneration and wound closure while reducing or eliminating the need to harvest 
autologous donor tissue in adults. 
Recent clinical data in adults demonstrate that treatment of DPT thermal burns with StrataGraft 
results in wound closure while reducing or eliminating the need for autograft. Although similar 
to the pivotal study in adults (ie, STRATA2016), this study of pediatric subjects will recruit not 
only younger subjects (ie, not adults) but also subjects with smaller TBSA burn. The reduced 
TBSA burn in pediatric subjects reflects the greater surface area to mass ratio of children 
compared to adults and the accompanying fluid status lability, limited physiologic reserves, as 
well as the reduced body size and attendant challenges. 
The present study is being conducted to explore the efficacy and safety of StrataGraft in pediatric 
subjects with thermal burns containing dermal elements to better understand the product profile 
in a pediatric population. 
6.4. 
Study Stopping Rules 
In this study, the medical monitor as well as the DMC will assess safety and efficacy. The DMC 
will be independent of study conduct and their activities governed by a Charter.  
Subject enrollment may be paused pending discussion with the DMC if any of the following 
events occur: 
• Unexpected infection at the StrataGraft treated site that is possibly or probably related 
to StrataGraft and is an SAE.  
• Severe acute hypersensitivity reaction attributed to StrataGraft.  
• Death attributed to StrataGraft.  

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In the event that one or more of the above occurs, the Sponsor will be notified, per timelines in 
Section 11.12. The medical monitor will review the safety data associated with the adverse 
reaction with the clinical investigator and generate a summary narrative. The medical monitor 
and DMC will conduct a comprehensive review of the safety data, prior to resumption of subject 
enrollment. 
6.5. 
End of Study Definition 
A subject is considered to have completed the study if the subject has completed the Month 12 
follow-up visit. The end of the study is defined as the completion of the final assessment for the 
last subject enrolled in the study. 
6.6. 
Discontinuation of Study Treatment 
Due to the nature of the study product and dressing requirements through the Day 7 visit, 
discontinuation of study investigational tissue product may not be feasible unless the subject 
manifests an adverse reaction within 7 to 10 days of application. 
6.7. 
Subject Discontinuation/Withdrawal from the Study 
Subjects are free to withdraw consent and discontinue participation in the study at any time. If a 
subject/parent/guardian decides to discontinue subject’s participation, the reason(s) for 
discontinuation will be documented.  
A subject’s participation may be discontinued at any time at the discretion of the investigator, if 
the subject is uncooperative, is noncompliant, or the investigator feels that it is in the subject’s 
best interest to be withdrawn from the study. Additionally, the subject may be considered lost to 
follow-up after 3 documented attempts are made to contact the subject. 
All study data from withdrawn or discontinued subjects will be retained and used in the final 
study analyses. Subjects withdrawn or discontinued from the study may be replaced and a new 
subject number assigned.  
 

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l   Note reason(s) for continued hospitalization such as pain management, fluid or nutritional status, infection risk, ongoing infection, inability to perform activities 
of daily living, insufficient social support, or other issues. 
m Start/stop date, dose, unit, frequency, route and indication for all prior (taken within the 14 days prior to Day 1) and concomitant medications (taken from 
Screening through the Month 12 end of study visit) and nondrug therapies (eg, blood transfusions, oxygen supplementation, physical therapy, etc) administered 
will be recorded. 
n Treatment site evaluations include assessment for signs & symptoms of infection or other adverse events and application of autograft. 
o Medical history to include significant past morbidities, surgical procedures, etc. Limited physical exam will include review of systems and assessment of burn 
area, depth and location(s). 
 
Anti-BSA = antibodies to bovine serum albumin; CMP = comprehensive metabolic panel; CBC = complete blood count w/ differential; EVENDOL = EValuation ENfant 
DOuLeur; FPRS = Wong-Baker Faces Pain Rating Scale; POSAS = Patient and Observer Scar Assessment Scale; PRA = panel reactive antibodies; PSAQ = Patient Scar 
Assessment Questionnaire. 

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7. 
SELECTION AND WITHDRAWAL OF SUBJECTS 
In this study, up to 50 subjects will be enrolled into one of two age cohorts: 2 to < 12 years (up to 
n = 40) and 12 to ≤ 17 years (up to n = 10). Subjects who fail to meet eligibility criteria 
following excision/debridement of their wound but before StrataGraft application may be 
replaced and a new subject number assigned. 
7.1. 
Subject Inclusion Criteria 
An included subject will be or have: 
1. Aged 2 to 17 years, inclusive, as of the time of consent. 
2. Written informed consent from parent(s) or legal guardian(s) and assent from the child 
when appropriate, as determined by the Institutional Review Board (IRB), consistent with 
regulatory criteria and requirements. 
3. Sufficient healthy skin identified and reserved as a donor site in the event that the 
StrataGraft treatment site(s) requires autografting. 
4. Thermal burns of no more than 30% TBSA. 
5. Consenting adult(s) is/are able and willing to attend/bring child to the scheduled visits 
and comply with study procedures. 
6. Study treatment area(s) that is/are: a) DPT in depth (ie, containing dermal elements) and 
for which excision and autografting are clinically indicated, as assessed by the 
investigator, and b) located on the torso or extremities. 
7. Study treatment area of 0.5% to 10% TBSA, which may be composed of up to 3 non-
contiguous areas located on the same extremity or plane of the torso. 
7.2. 
Subject Exclusion Criteria 
An excluded subject will be or have: 
1. Pregnant or breastfeeding. 
2. Receiving systemic immunosuppressive therapy and/or systemic corticosteroids (inhaled 
corticosteroids are allowed) 
3. A known history of malignancy. 
4. Pre-admission insulin-dependent diabetes. 
5. Concurrent trauma, conditions, and/or personal situations that, in the opinion of the 
investigator, may compromise subject safety or the study objectives. 
6. Burn injury occurred ≥ 14 days prior to StrataGraft application. 
7. An expected survival of less than 12 months. 
8. Participated in an interventional study of a drug, device, or biologic within the 90 days 
preceding enrollment. 
9. Proposed study site(s) has/have been previously excised and/or autografted. 

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10. Proposed study site(s) are located adjacent to an unexcised burn area. 
11. Proposed study site(s) demonstrate signs and symptoms of wound infection, per judgment 
of the clinical investigator. 
12. Proposed study sites(s) lie across joints or are located on the feet (ie, distal to the 
malleolus), hands (distal to the wrist), face, neck, buttocks, perineum, or genitalia.  
7.3. 
Screen Failures 
Screen failures are defined as subjects who consented to participate in the clinical study but were 
not subsequently treated with StrataGraft. 
Subjects who do not meet all of the eligibility criteria will be deemed a screen failure, and the 
following information will be recorded: 
• Demographics (age, sex, race/ethnicity); 
• Assessment of eligibility criteria; 
• Reason for screen failure; and 
• Any AE experienced by the subject following written, informed consent until 
excluded from study participation. 
 

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8.2. 
Prior and Concomitant Medications/Therapies 
The start and stop date, dose, unit, frequency, route of administration, and indication for all prior 
(taken within the 14 days prior to Day 1) and concomitant medications (taken from Screening 
through the Month 12 end of study visit) will be recorded. Start and stop dates of non-drug 
therapies (eg, oxygen supplementation, physical therapy, etc.) administered. Dates of transfusion 
of transfusions of blood or blood components as well as the number of units transfused will be 
recorded.  
At investigator discretion, treatment of infected/suspected infected wound sites may include the 
use of targeted wound cleansing agents, topical antimicrobial agents and/or systemic antibiotics. 
Study wound sites may not be treated with any prohibited therapies, as outlined in Section 8.2.2. 
8.2.1. 
Permitted Concomitant Therapies 
Subjects may continue all normally prescribed medication regimens during this study and must 
notify the investigator when changes are made to their medication regimens. Childhood 
vaccinations may continue as scheduled during study participation. 
Therapies designed to optimize scar outcome may be implemented as per institutional standard 
of care and may include, but are not limited to, range-of-motion exercises, massage, 
compression, and silicone dressings. Use of these therapies will be recorded. 
8.2.2. 
Prohibited Therapies 
Starting with Screening, the following treatments are not permitted: 
• Application of any silver- or sulfa-containing topical agents (including mafenide 
acetate) or dressings to the StrataGraft treatment site through confirmed complete 
wound closure.  
• Use of chlorhexidine- or iodine-based skin cleansers until confirmed, complete 
wound closure. Such cleansers may be used for wound preparation prior to 
StrataGraft application and must be thoroughly rinsed off prior to placement. 
• Use of any investigational drug, device, or procedure administered as part of a 
research study. 
• Use of laser therapy to scars located on the StrataGraft treatment site through 
completion of the Month 12 visit. 
If any prohibited therapy is administered during the study, all pertinent information will be 
recorded. The designated study medical monitor must be informed immediately upon discovery 
of such use.  
8.3. 
Study Treatment Compliance 
StrataGraft will be administered by investigator or sub-investigator(s) at the study site, and 
subjects will be followed to ensure compliance with wound care regimen. 

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8.4. 
Randomization and Blinding 
Not applicable. This is an open-label study. 

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9. 
INVESTIGATIONAL PRODUCT MATERIALS AND 
MANAGEMENT 
Detailed information regarding shipping, receipt, handling, storage, preparation, and 
accountability of IP may be found in the Manual of Procedures and are only briefly addressed in 
this section. 
9.1. 
Investigational Product 
The IP for this study is StrataGraft, a viable, bioengineered, allogeneic, cellularized scaffold 
product composed of a differentiated epidermal compartment comprising epidermal cells from a 
single human donor grown on a dermal equivalent composed of purified Type I animal collagen 
containing normal human fibroblasts from a second donor. 
9.2. 
Investigational Product Packaging and Labeling 
The IP, StrataGraft, will be provided by Stratatech Corporation and each piece will be labeled 
per local and national requirements.  
9.3. 
Investigational Product Receipt and Storage  
StrataGraft will be shipped to the study site on dry ice. Upon arrival at the site, StrataGraft may 
be maintained in the sealed shipping container until the data and time indicated on this container. 
If StrataGraft will not be used until after the date and time indicated on the shipping container, 
upon arrival at the site, StrataGraft should be transferred from the shipping container to a secure, 
ultra-cold (-70°C to -90°C) freezer with monitored temperature. Details regarding shipment and 
storage requirements can be found in the Manual of Procedures. Once StrataGraft has been 
received at the site, any excursion from required storage range (-70°C to -90°C) must be reported 
to the Sponsor as soon as the temperature fluctuation becomes known and prior to clinical use. 
9.4. 
Investigational Product Preparation and Administration 
StrataGraft is supplied as a rectangular cellularized sheet of approximately 100 cm2 and is 
applied topically by the investigator. The necessary procedures for preparing the product for 
administration are provided in the Manual of Procedures. 
9.5. 
Investigational Product Accountability 
In accordance with the International Council on Harmonisation (ICH) requirements, the 
investigator will account for all study IP furnished to the study site. An accountability record will 
be maintained for this purpose. An accounting for each unit of IP provided will be maintained, 
noting dates of receipt and use, as well as ultimate disposition. The investigational product will 
be maintained under locked/secured, temperature-controlled storage conditions at the study site.  
9.6. 
Investigational Product Handling and Disposal 
See Manual of Procedures for complete instructions. 

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10. 
SCHEDULE OF STUDY EVALUATIONS 
Section 6.8 contains a Table of Study Events and Assessments. 
10.1. 
Screening  
Screening assessments and baseline procedures must be completed within 14 days of injury. 
The following assessments and procedures will be performed during the Screening period: 
• Obtain written informed consent and subject assent, as appropriate (Section 11.1). 
• Collection of medical history, including etiology of the burn injury (Section 11.2.1). 
• Collection of concomitant medications (Section 11.4). 
• Collection of height and body weight (Section 11.2.3). 
• Abbreviated physical assessment, including assessment of vital signs (Section 11.2). 
• Assessment of total burn area (% TBSA burn), depth and location(s) (Section 11.3). 
• Evaluation of burn wound for signs of infection (Section 11.3.6). 
• Pregnancy test for females of child-bearing potential (Section 11.2.2). 
• Assess for any AEs (Section 11.9). 
• Collection of clinical laboratory assessments for comprehensive metabolic panel 
(CMP) and complete blood count (CBC) with differential (Section 11.5), if in medical 
record, or collection of samples for these assessments if venipuncture performed 
− Micro collection is encouraged for all subjects weighing less than 26 kg to reduce 
volume of sample.  
10.2. 
Treatment Day 1 (Day of Excision/Debridement and Investigational 
Product Application) 
Application of StrataGraft must be completed within 14 days of injury. 
The following assessments and procedures will be performed: 
• Obtain vital signs (Section 11.2.4).  
• Collection of concomitant medications (Section 11.4). 
• Collect archival blood sample (Section 11.6). 
• Collect baseline laboratory samples for CMP and CBC with differential 
(Section 11.5) if values were not obtained or samples not collected during Screening 
and within 48 hours of study treatment. 
− Micro collection is encouraged for all subjects weighing less than 26 kg to reduce 
volume of sample.  

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− Laboratory assessments performed within 48 hours of the study procedure will be 
abstracted from the medical record and serve as baseline study assessments. If not 
available, samples will be obtained for Baseline. 
• Collect baseline PRA and anti-BSA antibody samples (Section 11.6). 
• Photograph the study site(s): 1) pre-excision/debridement, 2) post-
excision/debridement, and 3) post-StrataGraft application. Thoroughly clean and 
excise/debride burn wounds (Section 11.3.4). 
• Clinically assess all wounds for the presence of infection (infected wounds and 
wounds adjacent to an infected site may not be used as study sites) (Section 11.3.6). 
• Assess wounds after excision/debridement and designate the Study treatment area of 
0.5% to 10% TBSA, which may be composed of up to 3 non-contiguous areas located 
on the same extremity or plane of the torso. (Section 8.1.2). 
• Apply StrataGraft (Section 8.1.2). 
• Document number of StrataGraft constructs applied (details are provided in the 
Manual of Procedures). 
• Assess for any AEs (Section 11.9). 
10.3. 
Treatment Days 7, 14, and 21 (± 2 days), Day 28 (± 3 days), and 
Weeks 5 - 11 (± 3 days) 
Subjects will be assessed weekly until complete wound closure of study treatment site(s) is/are 
confirmed. The following assessments or procedures will be performed at those visits: 
• Obtain vital signs (Section 11.2.4). 
• Remove all dressings and expose study treatment site(s). Reapply dressings, if 
necessary, after all wound assessments are complete. 
• Photograph all study treatment site(s) (Section 11.3.4). Photographs may be taken by 
study site personnel, or by trained caregivers if the subject is not able to attend the 
study site. 
• Assess each study treatment site for: 
− Signs and symptoms of infection and, if infection is suspected, assess and treat as 
outlined in Section 11.3.6 and Section 11.9.1.5.  
− The percent re-epithelialized of the study site until complete closure is noted 
(Section 11.3.2). 
− Autograft placement on study treatment site since last study visit, noting area 
autografted, if any; placement is assessed until complete closure is noted 
(Section 11.3.3). 
− Complete closure and, if closed, confirm the maintenance of closure at the next 
visit (Section 11.3.2). After the first observation of closure, confirmation of wound 

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closure will be done at a second visit at least 2 weeks after initial observation but no 
later than Week 20. 
• Assess pain at the study treatment site(s) using the EVENDOL (observer or parent) or 
FPRS (subject) rating scale (Section 11.7). 
• Document reason(s) for continued hospitalization if subject has not been discharged 
(Section 11.8).  
• Update any changes to concomitant medications and/or procedures, including any 
readmission to hospital related to the study wound(s) or scar management measures 
(Section 11.4). 
• Abstract from the medical record results of any safety laboratory results (ie, CBC 
with differential and CMP) performed since prior visit (Section 11.5). If no recorded 
values in medical record from Day 28 through Week 11, samples for CBC with 
differential and CMP may be collected during a clinically necessary venipuncture. 
Only 1 post-baseline sample per subject is needed.  
• PRA and anti-BSA antibody samples may be collected at any visit after Week 6, but 
only if they may be collected during a clinically necessary venipuncture 
(Section 11.6). Only 1 post-baseline sample per subject is needed. 
• Once closed, obtain POSAS and PSAQ assessment of study treatment site(s) 
(Section 11.3.5). 
• Assess for any AEs (Section 11.9). 
10.4. 
Treatment Week 12 (± 1 week) and Months 6 and 12 (± 1 month) 
The following assessments or procedures will be performed: 
• Obtain vital signs and measure height/length and body weight (Section 11.2.3 and 
Section 11.2.4). 
• Remove all dressings, if any, and expose study treatment site(s). After assessments 
are completed, reapply dressings, if necessary. 
• Photograph all study treatment site(s) until complete closure, or the study site is 
autografted, then photograph all study treatment sites at Week 12 and Months 6 and 
12 (Section 11.3.4). 
• Assess each study treatment site for: 
− Signs and symptoms of infection and, if infection is suspected, assess and treat as 
outlined in Section 11.3.6 and Section 11.9.1.5. 
− The percent re-epithelialized of study treatment site(s) until complete closure is 
noted (Section 11.3.2). 
− Autograft placement on study treatment site(s) since last study visit, noting area 
autografted, if any; placement is assessed until complete closure is noted 
(Section 11.3.3). 

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− If closed, confirm the maintenance of closure of study treatment site(s) at the next 
visit (Section 11.3.2).  After the first observation of closure, confirmation of 
wound closure will be done at a second visit at least 2 weeks after initial 
observation but no later than Week 20 
• Assess pain at the treatment site(s) using the EVENDOL (observer or parent) or 
FPRS (subject) rating scale (Section 11.7). 
• Document reason(s) for continued hospitalization if subject has not been discharged 
(Section 11.8).  
• Update any changes to concomitant medications and/or procedures, including any 
readmission to hospital related to the study wound(s) or scar management measures 
(Section 11.4). 
• Obtain POSAS and PSAQ assessment of study treatment site(s) (Section 11.3.5). 
• PRA and anti-BSA antibody samples may be collected at any visit after Week 6, but 
only if they may be collected during a clinically necessary venipuncture 
(Section 11.6). Only 1 post-baseline sample per subject is needed. 
• Assess for any AEs (Section 11.9). 

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11. 
STUDY ASSESSMENTS AND PROCEDURES 
All study assessments and times are listed in the Schedule of Study Events (Section 6.8). General 
instructions for the administration of these assessments are provided in the following 
subsections. Additional (unscheduled) safety assessments may be performed as needed. Specific 
instructions and questionnaires/forms (where appropriate) will be provided in a study manual. 
All assessments will be recorded in the electronic case report form (eCRF).  
It is expected the subjects will attend all scheduled study visits. Should a subject be unable to 
participate in an in-person visit, wound assessments and solicitation of AEs may be performed 
by telemedicine/video interactions. However, no assessment of wound re-epithelialization nor 
observation or confirmation of closure may be performed via video/telemedicine visits. These 
wound assessments may be performed only during a face-to-face visit. 
11.1. 
Informed Consent/Assent 
The parents and/or guardians of minor children must provide written consent for the participation 
of their child/ward in this study prior to any study assessment. Only informed consent forms 
reviewed and approved by the IRB of record may be used.  
Minor children will be assessed for their level of comprehension and involved in the consent 
process as appropriate. For purposes of this study, assent to participate will be obtained from the 
child, when appropriate, as determined by the IRB, and consistent with regulatory criteria and 
requirements.  
Subjects who reach the age of majority (usually 18 years of age) during their participation in the 
study will be re-consented. 
11.2. 
Screening Assessments 
The screening period is a maximum of 14 days from the day of injury to Day 1. The screening 
assessments will help to determine eligibility for study enrollment. During this period, the 
prospective study sites will be managed nonoperatively per the institution’s standard of care. 
Subjects and/or parent/guardian will provide informed consent prior to any study-specific 
assessments being performed. If, following excision/debridement, the designated potential study 
site does not meet eligibility criteria, the subject will be considered a screen failure and no 
further assessments or study procedures will be performed. Only after excision/debridement of 
the study site and application of StrataGraft will the subject be considered “enrolled.” 
11.2.1. 
Medical History and Physical Examination 
Significant medical history will be collected using an abbreviated review of systems with 
particular attention to any previous surgical procedures performed, hospitalizations, diagnosed 
chronic conditions and any routinely administered medications. The date of last menstrual period 
will be collected from post-menarche females. 
The physical examination will be performed to include evaluation of lungs, heart, abdomen, and 
extremities. The findings of the physical examination will be recorded.  

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Finally, background on the injury itself, including the date of the burn, date of first 
hospitalization, and etiology of the burn will be collected.  
11.2.2. 
Pregnancy Test 
A pregnancy test will be conducted for females of child-bearing potential. Results must be 
available prior to Day 1. Subjects with positive results at Screening are excluded from 
participation in this study. Serum testing is preferred, but urine testing is acceptable. 
If applicable, the subject’s agreement to use contraception throughout their study participation 
will be documented (see Appendix 3).  
11.2.3. 
Height and Body Weight 
The screening height and body weight measurements will be used to calculate body surface area. 
Height and body weight will be obtained at certain study visits as indicated in the Schedule of 
Study Events (Section 6.8). 
11.2.4. 
Vital Signs 
Vital signs will be obtained with the subject at rest and will include systolic and diastolic blood 
pressures, pulse rate, respiratory rate, and body temperature. The results, date, and time for all 
vital sign assessments will be recorded. Any change from the Screening vital signs that is 
considered clinically significant by the investigator will be recorded as an AE. 
11.3. 
Study Site Assessments 
11.3.1. 
StrataGraft Application 
On Day 1, following excision/debridement of study burn wound(s), the treatment site(s) will be 
identified and following fenestration/meshing, sheet(s) of StrataGraft will be applied and 
secured. The number of StrataGraft constructs applied to each treatment site will be documented. 
Details are provided in the Manual of Procedures. 
11.3.2. 
Wound Closure Assessment 
After excision/debridement and application of study treatments, the investigator will examine the 
study site(s) as per the Schedule of Study Events (Section 6.8) and visually assess wound 
closure, documenting a quantitative assessment of the proportion of the wound that is 
re-epithelialized. For this study, confirmed complete wound closure is defined as, “complete 
re-epithelialization of the wound without drainage” observed at 2 consecutive visits at least 2 
weeks apart (FDA, 2006), but no later than Week 20.  
11.3.3. 
Area of the Study Sites Autografted 
The area of each StrataGraft treatment site that is autografted will be measured during the 
autografting procedure. Details about obtaining wound measurements is provided in the Manual 
of Procedures. 

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11.3.4. 
Photography of Treatment Sites  
All StrataGraft treated sites will be photographed in the operating room and at each study visit to 
serially assess the area(s) of open wound in each treatment site. The photographer will be a 
trained study team member or trained caregiver. Subjects will attend weekly visits until complete 
wound closure is confirmed. Following confirmed complete wound closure, or if subjects cannot 
attend the study site, subjects and/or caregivers will be asked to photograph their wounds so that 
ongoing closure of their wound(s) can be assessed. In the event of a wound-related adverse 
event, photos of the affected wound will be taken to help document the event. Specific 
instructions and guidelines for photo-documentation will be provided in the Photography 
Manual. 
11.3.5. 
Skin Quality of Treatment Sites 
The POSAS (Patient Observer Scar Assessment Scale) will be used to assess the StrataGraft 
treated site(s) at visits designated in the Schedule of Study Events (Section 6.8). The POSAS 
scale has 2 components: the observer assessment and the subject assessment. The observer 
assessment uses a 10-point scale to assess vascularity, pigmentation, thickness, height, pliability, 
surface area, and overall opinion, while the subject component uses the same 10-point scale to 
assess pain, itching, stiffness, color, thickness, and overall opinion of StrataGraft treated sites. 
The investigator will complete the Observer POSAS assessment and a parent/guardian will 
complete the subject assessment on behalf of subjects unable to do so themselves. 
The PSAQ (Patient Scar Assessment Questionnaire) was created specifically to assess linear 
scars and has not previously been used to assess burn scars. However, one of the 5 subscales 
within the tool is a subjective assessment of a subject’s satisfaction with their scar, an assessment 
that is not made in the POSAS. In its development, the PSAQ demonstrated internal consistency 
for each subscale, including the Satisfaction with Appearance subscale (Cronbach ɑ of 0.89 to 
0.94), as well as high test-retest reliability (intraclass correlation coefficient [ICC] of 0.67 
to -0.83) of the same, demonstrating a high level of reliability in the use of the subscales 
independently. Only the 9 items of the Satisfaction with Appearance subscale will be completed 
by the subject or a parent/guardian (on behalf of subjects unable to do so themselves) at each 
assessment per the Schedule of Study Events (Section 6.8). 
11.3.6. 
Other Wound Assessments 
The StrataGraft treatment site(s) will also be assessed for clinical signs of infection, and the 
investigator will document the appearance of the wound using various descriptive terms. At 
investigator discretion, treatment of infected/suspected infected wound sites may include the use 
of targeted wound cleansing agents, topical antimicrobial agents (excluding silver and 
sulfa- -containing treatments such as mafenide acetate) and/or systemic antibiotics. Wound-
related adverse events will be documented with photographs of the affected wound. See 
Section 11.9.1.5 for further details.  
11.4. 
Concomitant Medications and Procedures 
The start and stop dates, dose, unit, frequency, route of administration, and indication for all 
prior and concomitant medications, nondrug therapies (eg, blood transfusions, oxygen 
supplementation, physical therapy, etc) and other procedures will be recorded in the eCRF. 

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11.5. 
Safety Laboratory Tests 
Results of CMP and CBC with differential, collected for clinical purposes, will be abstracted 
from the medical record. If such results are not available, blood samples for research purposes 
will be collected only as part of a clinically necessary venipuncture. Clinical sample analysis for 
CMP and CBC with differential studies will be performed at the institution’s local laboratory. 
Investigators must review and sign laboratory reports and document the clinical significance of 
any laboratory abnormalities. New, clinically significant laboratory abnormalities or clinically 
significant changes in laboratory values will be reported as AEs. 
11.6. 
Immunological Assays and Archival Samples 
Panel reactive antibodies (PRA), anti-BSA antibody and archival samples will be obtained prior 
to StrataGraft application from all enrolled subjects. Samples for the assessment of PRA and 
anti-BSA antibodies will also be obtained between Week 7 and Month 6 for all treated subjects. 
Specific instructions for collection, processing, storage, and shipment of these samples will be 
provided in the Laboratory Manual. 
11.7. 
Pain Assessment 
The EVENDOL pain assessment scale, a tool validated in preverbal children, will be used to 
assess pain in enrolled subjects up to 5 years of age (inclusive). The EVENDOL scale is 
designed such that it can be completed by an observer (eg, parent) based upon outward 
behavioral manifestations such as crying, facial expressions, movements and posturing as well as 
environmental interactions (Fournier-Charrière, 2012).  
The FPRS (FACES pain rating scale), a well-documented and validated tool, will be used to 
assess pain in enrolled subjects older than 5 years of age. The FPRS is demonstrated to 
effectively evaluate pain using a Likert-like scale of facial expressions, which are converted into 
numeric values to obtain a quantitative assessment of pain (Wong, 1998).  
Details regarding administration of the pain assessment tools are provided in the Manual of 
Procedures. 
11.8. 
Assessment of the Need for Continued Hospitalization 
At each study visit subsequent to Day 1 but prior to hospital discharge, an assessment of the need 
for continued hospitalization will be completed. Investigators will be asked to identify the 
reason(s) for continued hospitalization including: pain management, fluid or nutritional status, 
infection risk, ongoing infection, inability to perform activities of daily living, insufficient social 
support, or other issues. 

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11.9. 
Adverse Events and Serious Adverse Events 
11.9.1. 
Definitions 
11.9.1.1. Adverse Event (AE) 
An AE is any untoward or undesirable medical occurrence in a subject who is administered a 
study treatment, which does not necessarily have to have a causal relationship with this 
treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal 
laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use 
of study treatment.  
Examples of AEs include but are not limited to: 
• Any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or 
other safety assessments (eg, ECG, radiological scans, vital signs measurements), 
including those that worsen from baseline, considered clinically significant in the 
medical and scientific judgment of the investigator (ie, not related to progression of 
underlying disease). 
• Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency and/or intensity of the condition. 
• New conditions detected or diagnosed after study treatment administration even 
though it may have been present before the start of the study. 
• Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
• Signs, symptoms, or the clinical sequelae of a suspected overdose of either study 
treatment or a concomitant medication. Overdose per se will not be reported as an 
AE/SAE unless it is an intentional overdose taken with possible suicidal/self-harming 
intent. Such overdoses should be reported regardless of sequelae. 
• “Lack of efficacy” or “failure of expected pharmacological action” per se will not be 
reported as an AE or SAE. Such instances will be captured in the efficacy 
assessments. However, the signs, symptoms, and/or clinical sequelae resulting from 
lack of efficacy will be reported as AE or SAE if they fulfill the definition of an AE 
or SAE. 
Events that do not meet the definition of an adverse events include: 
• Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments which are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the participant’s condition. 
• The disease/disorder being studied or expected progression, signs, or symptoms of the 
disease/disorder being studied, unless more severe than expected for the participant’s 
condition. 
• Medical or surgical procedure (eg, endoscopy, appendectomy): the condition that 
leads to the procedure is the AE. 

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• Situations in which an untoward medical occurrence did not occur (social and/or 
convenience admission to a hospital). 
• Anticipated day-to-day fluctuations of pre-existing disease(s) or condition(s) present 
or detected at the start of the study that do not worsen. 
• Failure to achieve complete wound closure by Week 12.  
11.9.1.2. Unexpected Adverse Event 
An unexpected AE is an AE which exhibits a different nature or severity than those identified in 
the Investigator’s Brochure or has not previously been noted in relationship to StrataGraft. 
11.9.1.3. Treatment Emergent Adverse Events 
Treatment-emergent AEs are defined as those that are not present at start of study treatment or 
that represent the exacerbation of a pre-existing condition during the treatment-emergent period. 
The treatment-emergent period is defined as the time from the application of StrataGraft to the 
end of the study.  
11.9.1.4. Serious Adverse Event (SAE) 
An SAE is defined as any untoward medical occurrence that results in any of the following 
outcomes: 
Death 
Death is an outcome of an event. The cause of death should be recorded and reported on 
the SAE Form. All causes of death must be reported as SAEs. The investigator should 
make every effort to obtain and send death certificates and autopsy reports to the Sponsor 
or designee, or state not available. See Section 4.4 for xenotransplantation considerations. 
Life-threatening  
An adverse event or suspected adverse reaction is considered “life-threatening if, in the 
view of either the investigator or Sponsor, its occurrence places the subject at immediate 
risk of death. It does not include an AE or suspected adverse reaction that, had it occurred 
in a more severe form, might have caused death. For example, hepatitis that resolved 
without evidence of hepatic failure would not be considered life-threatening, even though 
hepatitis of a more severe nature can be fatal. Similarly, an allergic reaction resulting in 
angioedema of the face would not be life-threatening, even though angioedema of the 
larynx, allergic bronchospasm, or anaphylaxis can be fatal. 
Inpatient hospitalization or prolongation of existing hospitalization 
Hospitalization is defined as an admission to a hospital. The following situations should 
not be reported as SAEs: 
• A hospitalization or prolongation of hospitalization is needed for a procedure 
required by the protocol. 

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• A hospitalization or prolongation of hospitalization is part of a routine 
procedure followed by the center (eg, stent removal after surgery). This should 
be recorded in the study file. 
• A hospitalization for a pre-existing condition that has not worsened. 
Persistent or significant incapacity 
The term disability means a substantial disruption of a person’s ability to conduct normal 
life functions. 
This definition is not intended to include experiences of relatively minor medical 
significance such as uncomplicated headache, nausea, vomiting, diarrhea, influenza, and 
accidental trauma (eg, sprained ankle) which may interfere with or prevent everyday life 
functions but do not constitute a substantial disruption. 
Congenital anomaly or birth defect 
After enrollment and follow up in this study, any pregnancy reported to occur will be  
            
followed to conclusion and all live-born children will be followed for 28 days following         
birth.  Any congenital anomaly or birth defect will be reported. 
Important Medical Events 
Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered serious when, based upon appropriate medical 
judgment, may jeopardize the subject or the subject may require medical or surgical 
intervention to prevent one of the outcomes listed above. Examples of such medical 
events include allergic bronchospasm requiring intensive treatment in an emergency 
department or at home, blood dyscrasias or convulsions that do not result in inpatient 
hospitalization, or the development of drug dependency or drug abuse. 
Anticipated Adverse Events 
Adverse events (serious or nonserious) that commonly occur in the study population or 
background regimen will be considered anticipated events. Such events include known 
consequences of the condition under investigation (eg, symptoms, disease progression) 
and other events that may be common in this study population. A list of anticipated 
events for this study population is provided in the Investigators Brochure. Anticipated 
events are to be recorded in the eCRF and reported as SAEs when serious. These SAEs 
will not be expedited to health authorities, but rather, included in aggregate safety reports.  
11.9.1.5. Adverse Event of Special Interest 
An adverse event of special interest (serious or nonserious) is one of scientific and medical 
concern specific to the sponsor’s product or program, for which ongoing monitoring and rapid 
communication by the investigator to the sponsor can be appropriate. AESI will be reported 
using the SAE/AESI Report Form and observe the same reporting timeline (Table 6). For this 
study, Adverse Events of Special Interest (AESI) include: 

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• Signs/symptoms of endotoxin reaction (ie., combination of hypo/hyperpyrexia, 
hypo/hypertension, tachycardia, tachypnea, and change in mental status) within 24 
hours after StrataGraft application  
• Unexpected or unusual infections  
• Dermatological malignancy 
If any of the above occurs, the event will be reported within 24 hours of first knowledge of the 
event and follow-up reports provided as changes in the event occur. Photographs will be taken of 
the affected wound(s) to document the AESI.  
11.9.2. 
Adverse Event Medical Management Plan 
In the event of an AE, the investigator will use accepted standard of care (medication or surgery) 
as needed. A tiered approach will be used for the medical management of complications specific 
to the study burn sites, as described below: 
• Initial management of local infection or immune reactions with topical antimicrobials 
or anti-inflammatory agents, respectively. 
• Systemic antibiotics or anti-inflammatory medications administered for infections or 
immunological responses that fail to respond to topical therapy. 
• For complications that do not respond to topical or systemic therapy, the treated 
wound may be excised and the complication managed with topical or systemic 
therapy, as necessary. 
• Based on clinical judgment, autograft may be applied to the resulting wound bed to 
expedite wound closure. 
11.10. 
Relationship to Investigational Product  
The investigator is obligated to assess the relationship between study treatment and each 
occurrence of each AE/SAE. 
There may be situations in which an SAE has occurred, and the investigator has minimal 
information to include in the initial report to the Sponsor. However, it is very important that the 
investigator always assesses causality for every event before the initial transmission of the SAE 
data to the Sponsor. 
The investigator may change his/her opinion of causality in light of follow-up information and 
send a SAE follow-up report with the updated causality assessment. 
The following classifications should be used when evaluating the relationship of AEs or SAEs to 
study treatment. 
Table 4: 
Adverse Event Relationships 
Relationship 
Definition 
Unrelated 
No relationship between the AE and the administration of study treatment; the AE 
can be explained by other etiologies such as concomitant medications or subject’s 
clinical state. 

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Relationship 
Definition 
Possibly related 
A reaction that follows a plausible temporal sequence from administration of the 
study treatment, has a biologically causal relationship with the study treatment, or 
for which an alternative explanation for the AE is lacking. The reaction might have 
been produced by the subject’s clinical state or other modes of therapy 
administered to the subject. 
Probably related 
A reaction that follows a plausible temporal sequence from administration of the 
study treatment and has a biologically causal relationship with the study treatment, 
and the influence of alternative factors for the AE is unlikely.  
11.11. 
Severity Assessment 
For purposes of consistency, if required the investigator may use the intensity grades presented 
in Table 5. 
Table 5: 
Adverse Event Intensity Grades 
Grade 
Definition 
Mild 
Does not interfere with subject’s usual function and activities. 
Moderate 
Interferes to some extent with subject’s usual function and activities. 
Severe 
Interferes significantly with subject’s usual function and activities. 
To ensure there is no confusion or misunderstanding of the difference between the terms 
“serious” and “severe,” which are not synonymous, the following note of clarification is 
provided: 
The term “severe” is used to describe the intensity of a specific event (as in mild, moderate, or 
severe myocardial infarction). The event itself, however, may be of relatively minor medical 
importance (such as a severe headache). This is not the same as “serious,” which is based on the 
subject/event outcome or action criteria usually associated with events that pose a threat to a 
subject’s life or functioning. Seriousness (not severity) serves as a guide for defining regulatory 
reporting obligations. 
If an AE increases in severity (eg, from moderate to severe); decreases in severity (eg, changes 
from moderate to mild); or if there is a change in seriousness, a new AE will be opened and the 
original AE will be closed. If an AE is still ongoing at the time of a subject’s completion of the 
last study follow-up visit, the resolution/stop date and time is left blank. 
11.12. 
Recording and Reporting Adverse Events 
Adverse events will be recorded starting at the signing of the informed consent form (ICF) and 
will be followed by the investigator until the AE is resolved or stabilized. All study site follow-
up should be documented.  
Adverse events, AESIs, and SAEs will be reported from execution of the ICF through 
completion of study participation. The investigator is required to record the AE, regardless of the 
severity of the event or its relationship to study treatment.  

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The investigator will attempt to establish a diagnosis of the event based on signs, symptoms, 
and/or other clinical information. Whenever possible, the diagnosis (not the individual 
signs/symptoms) will be documented as the AE/SAE. 
The investigator must follow all AEs until the event has resolved or stabilized or at such time, 
the investigator refers the subject to a non-study physician. The investigator will document 
further all of the follow-up information in the subject’s source documents.  
The investigator is responsible for reporting all AEs as presented in Table 6. 
Table 6: 
Reporting Requirements for Adverse Events 
Category 
Reporting Time 
Type of Report 
Serious 
adverse events, 
and AESIs 
Within 24 hours of first knowledge 
of event 
Initial report on the SAE/AESI Form, 
appropriate eCRF, and source document 
Within 24 hours of receipt of 
follow-up information 
Follow up report on the Follow-up 
SAE/AESI Form, appropriate eCRF, and 
source document 
Nonserious 
adverse events 
Per case report form submission 
procedure 
Appropriate eCRF and source document 
AESI = adverse event of special interest; eCRF = electronic case report form; SAE = serious adverse 
event. 
 
It is not acceptable for the investigator to send photocopies of the participant’s medical records 
to the Sponsor in lieu of completion of the SAE report form. 
There may be instances when copies of medical records for certain cases are requested by the 
Sponsor. In this case, all participant identifiers, with the exception of the participant number, will 
be redacted on the copies of the medical records before submission to an agency. 
11.13. 
Pregnancy Reporting 
If a female subject, or the female partner of a male subject, becomes pregnant during the study, 
the investigator will report to the Sponsor as soon as she/he becomes knowledgeable of the 
pregnancy. The subject will be followed for the duration of the pregnancy and the outcome (eg, 
spontaneous abortion, live birth, still birth, congenital anomalies, birth defects) will be reported 
to the Sponsor as soon as it is known. If the pregnancy results in a live birth, a postdelivery 
follow-up will be performed at least 28 days after the baby is born and must be reported to the 
Sponsor’s pharmacovigilance personnel, or designee, within 24 hours of the study site becoming 
aware of the follow-up information. 
Information including the definition of Woman of Childbearing Potential (WOCBP), 
Contraceptive Guidance, and Collection of Pregnancy Information can be found in Appendix 3. 

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12. 
STATISTICAL CONSIDERATIONS 
12.1. 
Sample Size Determination 
Approximately 50 subjects will be enrolled into one of two age cohorts: up to 40 subjects in 2 to 
< 12 years cohort or up to 10 subjects in 12 to < 17 years.  
An overall sample size of 50 subjects will provide greater than 90% power to determine that at 
least 50% of the subjects achieve confirmed complete closure of all StrataGraft treatment sites on 
or before Week 12 without autograft placement, assuming that the actual proportion of subjects 
with confirmed complete closure of all StrataGraft treatment sites without autografting will be > 
83%. This assumption is based upon the results of a study in adults for the same indication 
(Holmes, 2020).   
Similar power is provided with the 40-subject sample of the 2 to < 12 years cohort, which is 
considered to be the more common group to be enrolled.  In the event that the 40 subjects have 
been enrolled into the 2 to < 12 years cohort but the enrollment into the older 12 to < 17 years 
cohort is not yet complete, the Sponsor reserves the right to close the study at their discretion. 
12.2. 
Analysis Populations 
The Intent-to-Treat (ITT) and Safety populations will include all enrolled subjects who received 
StrataGraft. 
12.3. 
Statistical Analyses 
This section provides a general summary of the statistical methods to be used in analyzing study 
data. A more detailed statistical analysis plan (SAP) will be provided in a separate document that 
will be finalized prior to database lock. SAS version 9.4 or newer will be used. 
Descriptive statistics for continuous variables will include the mean, median, standard deviation, 
minimum value, and maximum value. Categorical data will be summarized by counts and 
percentages. 
12.3.1. 
Efficacy Analyses 
12.3.1.1. Primary Endpoint 
The pediatric study plans to enroll up to 50 subjects into two age cohorts: 2 to ≤ 12 years and 
12 to ≤ 17 years. Endpoints will be assessed using the entire ITT population. 
The primary efficacy endpoint for this study the percentage of subjects achieving confirmed 
complete closure of all StrataGraft treatment sites on or before Week 12 without autograft 
placement. For subjects with more than one treatment site, all treatment sites must be confirmed 
closed before the subject can be declared to be confirmed closed. Confirmed complete wound 
closure is defined as complete skin re-epithelialization confirmed at 2 consecutive visits at least 2 
weeks apart but no later than Week 20. Complete confirmed wound closure will be considered to 
have occurred at the earlier of the two observations of complete skin re-epithelialization without 
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For the primary efficacy endpoint, number (%) and 95% Confidence Interval (CI) derived from 
the normal approximation to the binomial will be summarized based on the ITT population. 
Subjects with missing data will be imputed as non-responders. The statistical significance for the 
primary endpoint is declared if the lower limit of the 95% CI of the endpoint is ≥ 50%. 
The analysis will also be performed based on all observed data, i.e, excluding any missing data. 
The analyses by age cohort will be presented. 
The Objective, Population, Hypothesis, Endpoint, and Intercurrent Events and Data Handling for 
the Primary Endpoint are described in Table 7. 
12.3.1.2. Ranked Secondary Endpoints 
After the primary endpoint is successfully reached, the ranked secondary efficacy endpoints will 
each be tested with a 2-sided confidence interval with 0.05 Type I error in a hierarchical manner 
in the rank order as in Table 8. The ranked secondary endpoints are: 
1. Mean of averaged percent area of StrataGraft treatment site closed per subject at 
Week 12 without autograft placement 
2. Number (%) of confirmed complete wound closures of the StrataGraft treatment sites 
on or before Week 12 without autograft placement  
3. Mean of averaged percent area of StrataGraft treatment site autografted by Week 12 
For continuous efficacy endpoints, missing data will not be imputed. Missing or incomplete 
binary variables will be imputed as failures. Missing data are anticipated to occur only if the 
subject is lost to follow-up because information can be obtained for a missing visit when the 
subject returns for a subsequent visit. If a subject has autograft placement, the data collected after 
the autograft placement will be censored.  
The averaged percent area closed per subject at Week 12 will be calculated as (Sum of percent 
area closed across treatment sites for a subject at Week 12/the total number of treatment sites on 
a subject). 
The percentage of StrataGraft treatment sites with confirmed complete wound closure on or 
before Week 12 will be calculated as [(Total number of StrataGraft treatment sites with 
confirmed complete wound closure without autografting on or before Week 12/Total number of 
treatment sites) x 100].   
The averaged percent area of StrataGraft treatment sites per subject autografted by Week 12 will 
be calculated as (Sum of percent area of StrataGraft treatment sites per subject autografted by 
Week 12/the number of treatment sites on that subject). It is a cumulative sum of percent area 
autografted for all nonmissing visits on or before Week 12.  
The summary statistics with 95% confidence interval (CI) and p-value based on null hypothesis 
specified in Table 8 for each endpoint from t-distribution will be presented based on the ITT 
population by designated treatment site and pooled designated treatment site. The analyses by 
age cohort will be presented. 

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12.3.1.3. Binary Endpoints 
For binary endpoints, number (%) of subjects and its 95% CI derived from the normal 
approximation to the binomial will be summarized based on ITT by designated treatment site and 
pooled designated treatment site. The denominator for a treatment site is determined by numbers 
of subjects with the designated site. The number and percent of missing data will be shown. 
The missing data of binary endpoints will not be imputed for exploratory endpoints.  
12.3.1.4. Exploratory Endpoints 
For continuous and binary exploratory endpoints, the analyses will be the same as ones in 
Section 12.3.1.2 and Section 12.3.1.3. For the time-to-event efficacy endpoint, the Kaplan-Meier 
curves will be presented based on the ITT population. Subjects not having any event during the 
study will have their time censored at the last available date in the study. The Kaplan-Meier 
estimates and 95% CIs for the 25th percentile, 50th percentile and 75th percentile will be 
presented. 
For each exploratory continuous endpoint, the summary statistics with 95% confidence interval 
(CI) will be presented based on the ITT population by designated treatment site and pooled 
designated treatment site. 
The exploratory endpoints for this study are: 
• Mean percent area of StrataGraft treatment site closed without autograft placement at 
Week 8 
• Mean Patient and Observer Scar Assessment Scale (POSAS) observer total score at 
Week 12, and Months 6 and 12. 
• Changes in skin quality outcome (POSAS and Patient Scar Assessment Questionnaire 
[PSAQ] scores) across time. 
• Incidence and severity of pain at the treatment site using EVENDOL (EValuation 
ENfant DOuLeur, ie, Evaluation of Child Pain; observer or parent) or FPRS (Wong-
Baker Faces Pain Rating Scale with 6 faces with expressions denoting degrees of 
pain; subject) over time. 
• Percent of subjects with complete closure of StrataGraft treatment site without 
autografting at Weeks 6 and 8 and Months 6 and 12.  
• Time to complete closure following application of StrataGraft.  
• Mean percent wound closure over time from Day 21 through Month 12. 
• Percent of subjects achieving and maintaining persistent wound closure at Months 6 
and 12. 
• Mean scar satisfaction based on PSAQ scores at Week 12 and Months 6 and 12. 

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Table 7: 
The Objective, Population, Hypothesis, Endpoint and Intercurrent Events and Data Handling for the Primary 
Endpoint 
Objective 
Population 
Hypothesis 
Endpoint 
Intercurrent Events and Data 
Handling 
To evaluate whether 
StrataGraft treatment 
eliminates or reduces 
the need for 
autografting and 
promotes wound 
closure in a pediatric 
population with 
thermal burns that 
contain intact dermal 
elements and for 
which autografting is 
clinically indicated. 
 
All enrolled 
subjects who 
received 
StrataGraft  
H0: The response rate of 
primary endpoint is less than 
or equal to the 50%    
H1: The response rate of the 
primary endpoint is greater 
than the 50%  
 
Positive study criteria:  
The lower bound of primary 
endpoint 95% CI derived 
from the normal 
approximation to the 
binomial > 50%. 
Percentage of subjects 
achieving confirmed 
complete closure of all 
StrataGraft treatment sites 
on or before Week 12 
without autograft placement. 
Confirmed complete wound 
closure is defined as 100% 
re-epithelialization 
confirmed at 2 visits at least 
2 weeks apart but before 
Week 20. 
Early discontinuation due to: 
• Withdrawal of informed 
consent 
• Lost to follow-up 
• Adverse event 
• Investigator decision 
• Death 
• Other 
Missing/incomplete data will be 
imputed as failure (ie, no confirmed 
complete wound closure). 
CI = Confidence Interval; LB = Lower Bound 
 
 
 

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Table 8: 
The Objective, Population, Hypotheses, Endpoints and Intercurrent Events and Data Handling for Ranked 
Secondary Efficacy Endpoints  
Objectives 
Population 
Hypotheses 
Endpoints 
Intercurrent events and 
data handling 
To evaluate the mean 
averaged percent of 
wound area closure of 
StrataGraft treatment site 
without autograft 
placement at Week 12 
All enrolled subjects who 
received StrataGraft 
H01:  Mean of averaged 
percent wound area 
closure of StrataGraft 
treatment site without 
autograft placement at 
Week 12 ≤ 50%  
H11:  Mean percent of 
wound area closure of 
StrataGraft treatment site 
without autograft 
placement at Week 12 
> 50% 
Mean of averaged percent 
area of StrataGraft 
treatment site closed 
without autograft 
placement at Week 12 
 
Early discontinuation due 
to: 
• Withdrawal of 
informed consent 
• Lost to follow-up 
• Adverse event 
• Investigator decision 
• Death 
• Other 
Missing/incomplete 
continuous variables will 
not be imputed. 
Missing/incomplete binary 
variable will be imputed 
as failure. 
To evaluate the number 
(%) of StrataGraft 
treatment sites with 
confirmed complete 
wound closure without 
autograft placement on or 
before Week 12 
 
All enrolled subjects who 
received StrataGraft 
H02: The response rate of 
StrataGraft treatment sites 
with confirmed complete 
wound closure without 
autograft placement on or 
before Week 12 is less 
than or equal to the 50%    
H12: The response rate of 
StrataGraft treatment Sites 
with confirmed complete 
wound closure without 
autograft placement on or 
before Week 12 is greater 
than the 50%  
Number (%) of 
StrataGraft treatment sites 
with confirmed complete 
wound closure without 
autograft placement on or 
before Week 12 
 

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Objectives 
Population 
Hypotheses 
Endpoints 
Intercurrent events and 
data handling 
To evaluate the mean 
averaged percent area of 
StrataGraft treatment sites 
autografted per subject by 
Week 12  
All enrolled subjects who 
received StrataGraft  
H02:  Mean of averaged 
percent area of StrataGraft 
treatment sites autografted 
per subject by Week 12 
>50%. 
H12:  Mean of averaged 
percent area of StrataGraft 
treatment sites autografted 
per subject by Week 12 
<50%. 
Mean of averaged percent 
area of StrataGraft 
treatment sites per subject 
autografted by Week 12 
 

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12.3.2. 
Safety Analyses  
All subjects who receive StrataGraft treatment will be included in the safety analyses. 
AEs will be coded using the Medical Dictionary for Regulatory Activities coding classifications 
and presented by preferred term within system organ class. The number of AEs and the number 
of subjects reporting AEs will be listed and summarized descriptively by body system, preferred 
term, severity, and causality by designed StrataGraft (SG) treatment site, and pooled SG 
designated treatment sites, non-SG burn site, donor site, another site and pooled for all sites.  All 
SAEs will be summarized and narratives will be created as appropriate. 
12.3.3. 
Handling of Missing Data 
Subjects will be encouraged to return to clinic for each scheduled visit. Direct observation of the 
wound and collection of data at scheduled times is essential to ensure the quality of the data. 
However, should a visit be missed, thereby resulting in missing data for that visit, the following 
approaches will be employed to manage the missing data. 
For the primary efficacy endpoint, missing/incomplete data will be imputed as failure (ie, no 
confirmed complete wound closure).  
For the ranked secondary endpoints, missing/incomplete data will not be imputed. 
A full description of missing data imputation methods for all endpoints will be described in 
detail in the SAP. 

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13. 
SUPPORTING DOCUMENTATION AND OPERATIONAL 
CONSIDERATIONS 
The study will be conducted in full compliance with applicable international, national, and local 
regulatory requirements, including US Food and Drug Administration (FDA) regulations, 21 
Code of Federal Regulations (CFR) Parts 56, 314.106 and 312.120 (where applicable), 
International Council on Harmonization (ICH) guidelines for Good Clinical Practice (GCP) in 
accordance with the ethical principles that have their origins in the Declaration of Helsinki, and 
European regulation 536/2014/EU (where applicable). 
13.1. 
Institutional Review Board (IRB) 
It is the responsibility of the investigator to obtain the approval of the IRB/independent ethics 
committee (IEC) before the start of the study. A copy of the approval letter along with a roster of 
IRB/IEC members and compliance letter or their US Department of Health and Human Services 
general assurance number will be provided to the Sponsor and retained as part of the study 
records. During the course of the study, the investigator will provide timely and accurate reports 
to the IRB/IEC on the progress of the study at appropriate intervals and at the completion of the 
study. The investigator will notify the IRB/IEC of SAEs or other significant safety findings per 
IRB/IEC guidelines. The study protocol, ICF, advertisements (if any), subject-facing materials, 
and amendments (if any) will be approved by the IRB/IEC in conformance with international, 
national, and local regulatory requirements. 
An investigator may not make any changes in the conduct of the study without IRB/IEC and 
Sponsor approval except when necessary to eliminate apparent immediate hazards to the 
subjects. A protocol change intended to eliminate an apparent immediate hazard to subjects may 
be implemented immediately; however, the change must then be documented, reported to the 
IRB/IEC and Sponsor within 5 working days, who will then submit the deviation to the 
appropriate regulatory agency in the required time frame, if appropriate.  
13.2. 
Financial Disclosure 
Investigators and sub-investigators will provide the Sponsor with sufficient, accurate financial 
information, as requested by the Sponsor, in order to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities. Investigators are 
responsible for providing updated information on financial interests periodically, as appropriate.  
13.3. 
Subject Information and Consent 
The ICF to be submitted to the IRB/IEC must be reviewed and approved by the Sponsor prior to 
IRB/IEC submission. Once approved, only the IRB/IEC-reviewed and -approved consent form 
may be used to consent subjects. The investigator will provide the Sponsor with a copy of the 
IRB/IEC’s written approval as well as the IRB/IEC-approved ICF prior to the start of the study. 
At Screening, and at any other time as may be required by the study, subjects/parents/guardians 
will be presented with the IRB/IEC-approved consent forms and any privacy authorization as 
required by local and national regulations (such as the Health Insurance Portability and 
Accountability Act [HIPAA] authorization form). Subjects/parents/guardians will be given a 
description of the study providing content as per the essential elements of informed consent, 

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allowed time to ask questions, asked to read the consent form(s) and then provided an 
opportunity to discuss the contents of these forms with study site personnel.  
As the subjects in this study are all minors at study enrollment, parents/guardians will be asked 
to sign these forms in compliance with ICH GCP and all applicable national and international 
regulations, before participating in any study-related procedures. Subjects and/or parent/guardian 
will be made aware that they may withdraw from the study at any time. Subjects unable to give 
written informed consent must orally assent to the procedures when having reached the 
appropriate age per local policies and written informed consent must be obtained in accordance 
with national and local laws, as applicable. Subjects who reach the age of majority (usually 
18 years of age) during their participation in the study will be re-consented. 
The ICF must contain all applicable elements of informed consent and the mandatory statements 
as defined by national and local regulations, including confidentiality. All versions of each 
subject's signed ICF (originals) will be maintained by the site. Copies of the signed copies of the 
consent form(s) and the HIPAA authorization form, if applicable, will be given to the 
subject/parents/guardians.  
If a subject withdraws consent and/or HIPAA authorization, the investigator may no longer 
disclose health information, unless it is needed to preserve the scientific integrity of the study. 
13.4. 
Master Identification List 
At the time of consent, each subject will be assigned a unique study identification number. The 
investigator or designee is responsible for maintaining a list of each subject’s name, medical 
record number and assigned study identification number. The investigator must follow all 
applicable privacy laws in order to protect a subject’s privacy and confidentiality. Information 
that could identify a subject will be blinded on any material received by the Sponsor. 
13.5. 
Data Protection 
Study subjects will be assigned a unique study identifier. All subject records or datasets that are 
transferred to the Sponsor will be identified by this unique study identifier only. Study site 
personnel are responsible for purging subject names and medical record number from any 
records shared with the Sponsor.  
Within the ICF, the subject/parents/guardians will be informed that his/her personal study-related 
data will be used by the Sponsor in accordance with local data protection laws. In addition, 
subject/parents/guardians will be informed that medical records may be examined by Clinical 
Quality Assurance auditors or other authorized personnel appointed by the Sponsor, by IRB/IEC 
members, and/or by inspectors/auditors from regulatory authorities. 
13.6. 
Committees Structure 
An independent DMC will be convened in order to ensure that the safety of subjects is 
adequately protected. The DMC objectives, composition, and operational details of its activities 
will be defined in the DMC Charter.  

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13.7. 
Dissemination of Clinical Study Data 
Study results and de-identified individual subject data will be released as required by local and/or 
national regulation.  
13.8. 
Data Quality Assurance 
The Sponsor performs quality control and assurance checks on all clinical studies that it 
financially supports. Before enrolling any subjects in this study, Sponsor personnel and the 
investigator review the protocol, the investigator’s Brochure, the eCRF and instructions for their 
completion, the procedure for obtaining informed consent, and the procedure for reporting AEs 
and SAEs. A qualified representative of the Sponsor will monitor the conduct of the study. 
The investigator will permit study-related monitoring, audits, IRB/IEC review, and regulatory 
inspections by providing direct access to original source data and documents. 
Each subject’s eCRF should be fully completed in a timely fashion, usually within 5 business 
days. 
If an investigator retires, relocates, or otherwise withdraws from conducting the study, the 
investigator must notify the Sponsor to agree upon an acceptable storage solution. Regulatory 
agencies will be notified with the appropriate documentation. 
Any changes in investigator(s) or sub-investigator(s) will be promptly disclosed to the Sponsor 
and will require an updated Statement of Investigator (ie, FDA form 1572). As such, the 
investigator must promptly disclose these changes to the Sponsor or their designee. 
The investigator must notify their IRB/IEC of protocol deviations in accordance with local 
regulatory and IRB/IEC requirements. 
The eCRF data are stored in a database and processed electronically. The Sponsor’s medical 
monitor will review the data for safety information. The data are also reviewed for completeness 
and logical consistency. Automated validation programs will identify missing data, out-of-range 
data, and other data inconsistencies. In addition, clinical laboratory data will be processed 
electronically. Requests for data clarification will be forwarded to the study site for resolution 
and responded to in a timely fashion, usually within 5 business days. 
13.9. 
Source Documents 
All subject information recorded in the eCRF will be attributable to source data from the 
investigational site. 
The investigator shall retain and preserve 1 copy of all data collected or databases generated in 
the course of the study, specifically including but not limited to those defined by GCP as 
essential. Essential documents should be retained until at least 2 years after the last approval of a 
marketing application or supplement in an ICH region and until there are no pending or 
contemplated marketing applications or supplements in an ICH region or at least 2 years have 
elapsed since the formal discontinuation of clinical development of the investigational medicinal 
product. These documents should be retained for a longer period, however, if required by the 
applicable regulatory requirements or by an agreement with the Sponsor. It is the responsibility 
of the Sponsor to inform the investigator/institution as to when these documents no longer need 

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to be retained. Prior to destruction of any study essential documents, the investigator must first 
obtain written approval from the Sponsor.  
13.10. 
Study and Site Closure 
The Sponsor may suspend or terminate the study or part of the study at any time for any reason. 
If the investigator suspends or terminates the study, the investigator will promptly inform the 
Sponsor and the IRB/IEC and provide them with a detailed written explanation. Upon study 
completion, the investigator will provide the Sponsor, IRB/IEC, and regulatory agency with final 
documents, reports, and summaries as required by regulations. Study termination and follow-up 
will be performed in compliance with the Sponsor’s or designee’s standard operating procedures.  
The Sponsor, investigator, or local and national regulatory authorities may discover conditions 
during the study that indicate that the study or study site should be terminated. This action may 
be taken after appropriate consultation between the Sponsor and investigator. Conditions that 
may warrant termination of the study/study site include, but are not limited to: 
• The discovery of an unexpected, serious, or unacceptable risk to the subjects enrolled 
in the study. 
• The decision on the part of the Sponsor to suspend or discontinue testing or 
evaluation of the investigational product. 
• Failure of the investigator to enroll subjects into the study at an acceptable rate. 
• Failure of the investigator to comply with pertinent regulations. 
• Submission of knowingly false information from the study site to the Sponsor, study 
monitor, or local and national regulatory authorities. 
• Insufficient adherence to protocol requirements. 
 

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14. 
REFERENCES 
American Burn Association. National Burn Repository 2019 Report of Data from 2009-2018. 
Chicago IL: American Burn Association, Dataset Version 14.0. 
Borse NN, Gilchrist J, Dellinger AM, et al. CDC childhood injury report: patterns of 
unintentional injuries among 0–19-year-olds in the United States, 2000-2006. Atlanta (GA): 
Centers for Disease Control and Prevention, National Center for Injury Prevention and Control; 
2008. 
Chipp E, Charles L, Thomas C, et al. A prospective study of time to healing and hypertrophic 
scarring in paediatric burns: every day counts. Burns Trauma 2017; 5:3. doi: 10.1186/s41038-
016-0068-2. eCollection 2017. 
FDA. Guidance for Industry: Chronic Cutaneous Ulcer and Burn Wounds – Developing Products 
for Treatment, 2006. 
Fournier-Charrière E, Tourniaire B, Carbajal R, et al. EVENDOL, a new behavioral pain scale 
for children ages 0 to 7 years in the emergency department: design and validation. Pain 2012; 
153(8): 1573-1582. 
Heimbach DM. Early burn excision and grafting. Surg Clin North Am 1987;67(1):93-107. 
Herndon DN, Barrow RE, Rutan RL, et al. A comparison of conservative versus early excision. 
Therapies in severely burned patients. Ann Surg 1989; 209(5): 547-552. 
Holmes JH, Shupp JW, Smith DJ, et al. T5: Preliminary analysis of a phase 3 open-label, 
controlled, randomized trial evaluating the efficacy and safety of a bioengineered regenerative 
skin construct in patients with deep partial-thickness thermal burns. J Burn Care Res 2020; 
41(Supplement1): S3-S4. 
Krishnamoorthy V, Ramaiah R, Bhananker SM. Pediatric burn injuries. Int J Crit Illn Inj Sci 
2012; 2(3):128–134.  
Kramer CB, Rivara FP, Klein MB. Variations in US pediatric burn injury hospitalizations using 
the national burn repository data. J Burn Care Res 2010; 31(5): 734-739. 
Muller MJ, Herndon DN. The challenge of burns. Lancet. 1994; 343(8891): 216-220.  
Munster AM, Smith-Meek M, Sharkey P. The effect of early surgical intervention on mortality 
and cost-effectiveness in burn care, 1978-91. Burns 1994; 20: 61-64.  
Pietsch JB, Netscher DT, Nagaraj HS, et al. Early excision of major burns in children: effect on 
morbidity and mortality. J Pediatr Surg 1985; 20(6): 754-757.  
Romanelli M, Serena T, Kimble R, et al. WUWHS Position Document: Skin graft donor site 
management in the treatment of burns and hard-to-heal wounds. Wounds International [Internet] 
2019. Available from www.woundsinternational.com. 
Sinha S, Schreiner AJ, Biernaskie J, et al. J Trauma Acute Care Surg 2017; 83(5): 954-964. 
Ward RM, Benjamin DK Jr, Davis JM, et al. The need for pediatric drug development. J Pediatr 
2018; 192: 13-21. 

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Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs 1998; 
14(1): 9-17. 

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APPENDIX 2. STUDY GOVERNANCE CONSIDERATIONS 
Ethical Considerations 
As the pediatric population is considered a highly vulnerable group of patients, based on age and 
inability to give full informed consent, it is important to address the ethics of clinical research in 
this group. Although the FDA has mandated that a pediatric program be initiated when a 
treatment is relevant to this population, nonetheless, some argue it is totally unethical for 
children to participate in clinical studies and become the human equivalent of a test animal 
(Ward, 2018), which prompts this discussion for the study of StrataGraft. 
There are several questions that should be addressed to justify this clinical study. These 
questions are: 1) is this disease only found in pediatric patients? 2) are alternate treatments 
available that are just as effective? and 3) will the study result in value to the subject or to the 
population of subjects that may receive the treatment? 
To address the first question, although burns of the nature to be recruited in this study, are seen 
across the age spectrum, the healing response may differ depending upon the recuperative 
abilities, which do not change with age. As such, the issue of burn treatment in this age group is 
unique. Second, there are alternate treatments that may be considered to be just as effective.  
However, there are collateral concerns about autografting that make the StrataGraft approach 
particularly attractive in this population. Should StrataGraft decrease or eliminate the need for 
autografting in pediatric children with DPT burns as it has been demonstrated to do in adults, 
then use of StrataGraft may be beneficial to these patients. Moreover, the ease of use of 
StrataGraft will be very helpful to hospitals and medical centers in isolated areas of the United 
States where dedicated burn units are geographically distant. 
This study will be conducted in accordance with the protocol and the following: 
• Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical 
Sciences (CIOMS) International Ethical Guidelines 
• Applicable ICH GCP Guidelines 
• Applicable laws and regulations 
• The protocol, protocol amendments, ICF, Investigator Brochure, and other relevant 
documents (eg, advertisements) must be submitted to an IRB/IEC by the investigator 
and reviewed and approved by the IRB/IEC before the study is initiated.  
• Any amendments to the protocol will require IRB/IEC approval before 
implementation of changes made to the study design, except for changes necessary to 
eliminate an immediate hazard to study participants.  
• The investigator will be responsible for the following: 
− Providing written summaries of the status of the study to the IRB/IEC annually or 
more frequently in accordance with the requirements, policies, and procedures 
established by the IRB/IEC 

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− Notifying the IRB/IEC of SAEs or other significant safety findings as required by 
IRB/IEC procedures 
− Providing oversight of the conduct of the study at the site and adherence to 
requirements of 21 CFR, ICH guidelines, the IRB/IEC, European regulation 
536/2014 for clinical studies (if applicable), and all other applicable local 
regulations 
Financial Disclosure 
Investigators and sub-investigators will provide the sponsor with sufficient, accurate financial 
information as requested to allow the sponsor to submit complete and accurate financial 
certification or disclosure statements to the appropriate regulatory authorities. Investigators are 
responsible for providing information on financial interests during the course of the study and for 
1 year after completion of the study. 
Informed Consent Process 
• The investigator or his/her representative will explain the nature of the study to the 
participant (who is capable of providing assent) and his/her legally authorized 
representative and answer all questions regarding the study. Participants and their 
legally authorized representative must be informed that their participation is 
voluntary. The statement of informed consent (ICF) that meets the requirements of 21 
CFR 50, local regulations, ICH guidelines, Health Insurance Portability and 
Accountability Act (HIPAA) requirements, where applicable, and the IRB/IEC or 
study center must be signed by the subject’s legally authorized representative as all 
subjects will be minors at the time of enrollment. Subjects who reach the age of 
majority (usually 18 years of age) during their participation in the study will be re-
consented. 
• The medical record of each study subject must include a statement that written 
informed consent was obtained before the participant was enrolled in the study and 
the date the written consent was obtained. The authorized person obtaining the 
informed consent must also sign the ICF. 
• Participants must be re-consented to the most current version of the ICF(s) during 
their participation in the study.  
• A copy of the ICF(s) must be provided to the participant and the participant’s legally 
authorized representative.  
Data Protection 
• Participants will be assigned a unique identifier by the sponsor. Any participant 
records or datasets that are transferred to the sponsor will contain the identifier only; 
participant names or any information which would make the participant identifiable 
will not be transferred.  
• The participant must be informed that his/her personal study-related data will be used 
by the sponsor in accordance with local data protection law. The level of disclosure 
must also be explained to the participant.  

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• The participant must be informed that his/her medical records may be examined by 
Clinical Quality Assurance auditors or other authorized personnel appointed by the 
sponsor, by appropriate IRB/IEC members, and by inspectors from regulatory 
authorities. 
Committees Structure 
An independent DMC will be convened in order to ensure that the safety of subjects is 
adequately protected. The DMC objectives, composition, and operational details of its activities 
will be defined in the DMC Charter. 
Publication Policy 
• The results of this study may be published or presented at scientific meetings. If this 
is foreseen, the investigator agrees to submit all manuscripts or abstracts to the 
sponsor before submission. This allows the sponsor to protect proprietary information 
and to provide comments.  
• The sponsor will comply with the requirements for publication of study results. In 
accordance with standard editorial and ethical practice, the sponsor will generally 
support publication of multicenter studies only in their entirety and not as individual 
site data. In this case, a coordinating investigator will be designated by mutual 
agreement. 
• Authorship will be determined by mutual agreement and in line with International 
Committee of Medical Journal Editors authorship requirements. 
Data Quality Assurance 
• All participant data relating to the study will be recorded on printed or electronic CRF 
unless transmitted to the sponsor or designee electronically (eg, laboratory data). The 
investigator is responsible for verifying that data entries are accurate and correct by 
physically or electronically signing the CRF.  
• The investigator must maintain accurate documentation (source data) that supports 
the information entered in the CRF.  
• The investigator must permit study-related monitoring, audits, IRB/IEC review, and 
regulatory agency inspections and provide direct access to source data documents.  
• The sponsor or designee is responsible for the data management of this study 
including quality checking of the data.  
• Study monitors will perform ongoing source data verification to confirm that data 
entered into the CRF by authorized site personnel are accurate, complete, and 
verifiable from source documents; that the safety and rights of participants are being 
protected; and that the study is being conducted in accordance with the currently 
approved protocol and any other study agreements, ICH GCP, and all applicable 
regulatory requirements.  
• All records, source documents, study worksheets, signed ICFs, and any other 
documents pertaining to the conduct of this study must be retained by the investigator 

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for at least 2 years after study completion or approval of the drug, whichever comes 
last, unless local regulations or institutional policies require a longer retention period. 
(US 21CFR§312.62). No records may be destroyed during the retention period 
without the written approval of the sponsor. No records may be transferred to another 
location or party without written notification to the sponsor.  
Source Documents 
• Source documents provide evidence for the existence of the participant and 
substantiate the integrity of the data collected. Source documents are filed at the 
investigator’s site. 
• Data reported on the CRF or entered in the eCRF that are transcribed from source 
documents must be consistent with the source documents or the discrepancies must be 
explained. The investigator may need to request previous medical records or transfer 
records, depending on the study. Also, current medical records must be available. 
Study and Site Closure 
The sponsor designee reserves the right to close the study site or terminate the study at any time 
for any reason at the sole discretion of the sponsor. Study sites will be closed upon study 
completion. A study site is considered closed when all required documents and study supplies 
have been collected and a study-site closure visit has been performed. 
The investigator may initiate study-site closure at any time, provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the sponsor or investigator may include but are 
not limited to: 
• Failure of the investigator to comply with the protocol, the requirements of the 
IRB/IEC or local health authorities, the sponsor's procedures, or GCP guidelines 
• Inadequate recruitment of participants by the investigator 
• Discontinuation of further study treatment development 
 

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APPENDIX 3.  CONTRACEPTIVE GUIDANCE AND COLLECTION OF   
PREGNANCY INFORMATION 
Woman of Childbearing Potential (WOCBP) 
A woman is considered fertile following menarche and until becoming post-menopausal unless 
permanently sterile. 
Non-WOCBP Status 
• Premenarchal 
• Permanently sterile female is a post-menarchal, pre-menopausal female with 1 of the 
following: 
− Documented hysterectomy 
− Documented bilateral salpingectomy 
− Documented bilateral oophorectomy 
Note: Documentation may come from the site personnel’s: review of the participant’s 
medical records, medical examination, or medical history interview. 
• A post-menopausal state is defined as no menses for 12 months without an alternative 
medical cause. A high follicle stimulating hormone (FSH) level in the post-
menopausal range may be used to confirm a post-menopausal state in women not 
using hormonal contraception or hormonal replacement therapy (HRT). Note that in 
the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.  
Pregnancy Testing 
Female participants of childbearing potential are eligible to participate in this study. All women 
of childbearing potential will be tested for pregnancy during Screening and if found to be 
pregnant, will be excluded from participation.  
Contraception 
Acceptable forms of contraception include hormonal measures (oral contraceptive pills, 
contraceptive patch, contraceptive ring, injections), intrauterine devices, double barrier method 
(condom plus diaphragm, condom or diaphragm plus spermicidal gel or foam), and abstinence. 
Collection of Pregnancy Information 
Female Participants Who Become Pregnant     
• The investigator will collect pregnancy information on any female participant who 
becomes pregnant while participating in this study. Information will be recorded on 
the appropriate form and submitted to the sponsor within 24 hours of learning of a 
participant's pregnancy. The participant will be followed to determine the outcome of 
the pregnancy. The investigator will collect follow-up information on the participant 
and the neonate and the information will be forwarded to the sponsor. Generally, 
follow-up will not be required for longer than 6 to 8 weeks beyond the estimated 

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delivery date. Any termination of pregnancy will be reported, regardless of fetal 
status (presence or absence of anomalies) or indication for the procedure. 
• While pregnancy itself is not considered to be an AE or SAE, any pregnancy 
complication or elective termination of a pregnancy will be reported as an AE or 
SAE. A spontaneous abortion is always considered to be an SAE and will be reported 
as such. Any post-study, pregnancy-related SAE considered reasonably related to the 
study treatment by the investigator will be reported to the sponsor. While the 
investigator is not obligated to actively seek this information in former study 
participants, he or she may learn of an SAE through spontaneous reporting. 
• Any female participant who becomes pregnant while participating in the study will 
continue with all scheduled study evaluations. Pregnant subjects will be followed 
until post-partum and the outcome of the pregnancy will be reported. 
 

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APPENDIX 4. COUNTRY-SPECIFIC REQUIREMENTS  
This study is planned for clinical sites in the USA that adhere to ICH guidances and GCP. No 
country-specific requirements further affect this study protocol. 
 
 

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APPENDIX 5. TOOLS USED FOR ASSESSMENT DURING THE STUDY 
 
Patient and Observer Scar Assessment Scale 
Patient Scale: 
 
 
 
Observer Scale: 
 
 
 

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Patient Satisfaction Assessment Questionnaire: Satisfaction with Appearance subscale 
 
 
 

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APPENDIX 6. SUMMARY OF CHANGES FROM VERSION 2 TO VERSION 3 
Formatting, consistency and minor editorial changes are not listed.  
  
Protocol Section  Removed text is strikethrough and added text is bold  
Issue/rationale for change  
1 Synopsis 
Name of Active Ingredient: StrataGraft, is a viable, bioengineered, and metabolically active 
allogeneic cellularized scaffold product composed of a differentiated epidermal compartment 
comprised of epidermal cells from a single human  donor grown on NIKS keratinocytes and 
human dermal equivalent composed of purified Type I animal collagen containing normal human 
fibroblasts from a second donor cellularized layered scaffold. 
 
Align language with NDC 736-200  
Page 4 
Version 2 3 includes changes to the Secondary Endpoints, Statistics and Safety Sections, as outlined 
in related to modifications in the xenotransplantation product requirements and prohibitions, 
which are reflected in Sections 4.4 and 11.9.1.5. Administrative issues and clarifications show 
changes in Section 1 (Synopsis) and Sections 6.1, 6.8, 8.2, 9.3, and 11. Appendix 6 is a table of the 
summary of changes. 
 
Outlines the changes made in this 
version the protocol 
 
 

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Protocol Section  Removed text is strikethrough and added text is bold  
Issue/rationale for change  
Section 4.4  
The US FDA considers StrataGraft to be is a xenotransplantation product because of an historic 
exposure of the epidermal cells to well characterized mouse cells.  Mouse cells are no longer used in 
the manufacture in the past, one of the cell types used to make StrataGraft was grown with 
mouse cells. The cell banks have been thoroughly tested and found to be free of detectable 
adventitious infectious agents, and there have been no reported zoonotic infection in clinical trials. 
and mouse cells are no longer used in the manufacture of StrataGraft. There have been no 
identified health concerns associated with these mouse cells.  However, the is a very low 
possibility that zoonotic infection could occur.  It is important that patients/parents/legal guardians be 
made aware that people who receive treatment with StrataGraft should not donate blood, blood 
components, plasma, leukocytes, tissues, breast milk, ova, sperm or body parts for transplantation. 
 
Recipients of xenotransplantation products are generally not eligible, per federal regulations, to 
donate whole blood, blood components, source plasma or source leukocytes.  However, 
individual blood banks may request an exception from FDA.  StrataGraft recipients wishing to 
donate blood or blood products should check with their donation center.  StrataGraft recipients 
who otherwise meet the donor requirements are eligible to donate human cells, tissues, breast 
milk, ova, sperm, or body parts for transplantation. 
 
A small amount of blood (3mL), called an archival sample, will be collected before StrataGraft 
application.  This sample could be used as a baseline to assess health issues that may be related to 
treatment.  These samples will be used only for the purpose of responding to a request from the FDA.  
Both archival samples and any associated patient subject information will be stored and used only as 
required and allowed by law. Finally, although not required, in the event of a recipient’s death, an 
autopsy should be considered. 
Reflects modifications of the 
xenotransplantation product 
prohibitions/requirements for 
StrataGraft as granted by the US 
FDA  
 
 

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Protocol Section  Removed text is strikethrough and added text is bold  
Issue/rationale for change  
Section 6.1  
Subjects will undergo baseline assessments including a targeted physical examination and collection 
of clinical laboratory assessments during Screening. After enrollment and StrataGraft application, 
wound assessments, photographs, and solicitation of AEs will be performed at each study visit via 
telephone or video interaction if the subject is unable to attend the visit. However, wound closure 
may only be assessed at face-to-face visits. If not collected during Screening, clinical laboratory 
samples will be collected via venipuncture performed prior to StrataGraft application on Day 1. 
Immunological samples (monitoring of PRA and anti-BSA antibodies) will be collected prior to 
StrataGraft application, and again between Week 76 and Month 6 for all treated subjects. 
Wound closure may not be assessed 
via telephone or video interaction. 
 
 
Amended the Immunologic sample 
collection timing to match the timing 
outlined in the Schedule of Events. 
Section 6.8, 
Table 2  
Wound closure assessment line added to the Schedule of Events table with appropriate annotations 
Clarify when wound closure 
observations are to be made 
 
 

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Protocol Section  Removed text is strikethrough and added text is bold  
Issue/rationale for change  
Section 6.8, 
Table 2 
d Safety laboratory results will be collected prior to StrataGraft application and abstracted from 
the medical record, if available. If such results are not available, blood samples for study purposes 
will be collected as part of a clinically necessary venipuncture. A second safety laboratory 
assessment will be performed between Study Day 28 and Study Week 11, with results 
abstracted from the medical record, if available, or collected as part of a clinically necessary 
venipuncture. 
e During the excision/debridement procedure, photographs will be taken of the study site(s) 1) pre-
excision/debridement, 2) post-excision/debridement, and 3) post-StrataGraft application. 
f Photograph all study treatment site(s) until complete closure, Week 12, or until the study burn is 
autografted; then photograph at Months 6 and 12. Photographs may be taken by trained caregivers or 
by study site personnel. 
g Conducted at the first observation of closure, Week 12 (if closed prior), and Months 6 and 12. 
h Immunological samples (monitoring of PRA and anti-BSA antibodies) will be collected prior to 
StrataGraft application and one time again between Week 6 and Month 6 for all treated subjects. 
i Archival blood samples will be collected before application of StrataGraft and shipped for long-
term storage. 
j Wounds will be assessed for percent re-epithelialization at least weekly, beginning at the Day 7 
visit, until complete wound closure is confirmed. Confirmation of closure will occur at least 2 
weeks after initial observation of wound closure but no later than Week 20. Maintenance of closure 
will be assessed at each subsequent study visit following confirmation of wound closure. 
k Assess pain only if wound is open 
l Note reason(s) for continued hospitalization such as pain management, fluid or nutritional status, 
infection risk, ongoing infection, inability to perform activities of daily living, insufficient social 
support or other issues 
n Treatment site evaluations include assessment for signs & symptoms of infection, percent re
epithelialization, closure and/or persistence of closure and application of autograft. 
m Start/stop date, dose, unit, frequency, route, and indication for all prior (taken within 14 days prior 
to Day 1) and concomitant medications (taken from Screening through the Month 12 end of study 
visit) and nondrug therapies (eg. blood transfusions, oxygen supplementation, physical therapy, etc) 
administered will be recorded. 
n Treatment site evaluations include assessment for signs & symptoms of infection or other 
adverse events and application of autograft. 
op Medical history to include significant past morbidities, surgical procedures, etc.  Limited physical 
exam will include review of systems and assessment of burn area, depth and location(s). 
q Assess percent closure at least weekly until first observation of complete closure. Complete wound 
closure will be confirmed at a second visit at least 2 weeks after initial observation of closure but no 
later the Week 20.  
 
 
Clarifications regarding footnotes to 
Table 2.  
 
Reordered alphabetically  
 

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Protocol Section  Removed text is strikethrough and added text is bold  
Issue/rationale for change  
Sections 8.1.2 and 
8.2  
(Section 8.1.2)  
At investigator discretion, treatment of infected/suspected infected wound sites may include the use of 
targeted wound cleansing agents, topical antimicrobial agents (excluding silver containing treatments), 
and/or systemic antibiotics.  
 
(Section 8.2) 
The start and stop date, dose, unit, frequency, route of administration, and indication for all prior 
(taken within the 14 days prior to Day 1) and concomitant medications (taken from Screening through 
the Month 12 end of study visit) will be recorded. Start and stop dates of non-drug therapies (eg, 
oxygen supplementation, physical therapy, etc.) administered. Dates of transfusion of transfusions of 
blood or blood components as well as the number of units transfused will be recorded.  
 
At investigator discretion, treatment of infected/suspected infected wound sites may include the 
use of targeted wound cleansing agents, topical antimicrobial agents and/or systemic antibiotics. 
Study wound sites may not be treated with any prohibited therapies, as outlined in Section 8.2.2. 
 
Migrated specific instructions related 
to treatment of infections to the 
section on concomitant 
medications/therapies. Linked to 
section on prohibited therapies. 
Section 9.3  
StrataGraft will be shipped to the study site on dry ice. Upon arrival at the site, the StrataGraft may be 
maintained in the sealed shipping container until the date and time indicated on this container. 
If StrataGraft will not be used until after the date and time indicated on the shipping container, 
upon arrival at the site, StrataGraft should be transferred from the shipping container to a secure, 
ultra-cold (-70°C to -90°C) freezer with monitored temperature. Details regarding shipment and 
storage requirements can may be found in the Manual of Procedures. Once StrataGraft has been 
transferred into a site’s ultra-cold freezer received at the site, any excursion from required storage 
range (-70°C to -90°C) must be reported to the Sponsor as soon as the temperature fluctuation 
becomes known and prior to clinical use. 
 
Clarification of acceptable product 
storage  
Section 11 
All study assessments and times are listed in the Schedule of Study Events (Section 6.8). General 
instructions for the administration of these assessments are provided in the following subsections. 
Additional (Unscheduled) safety assessments may be performed as needed. Specific instructions and 
questionnaires/forms (Where appropriate) will be provided in a study manual. All assessments will 
be recorded in the electronic case report form (eCRF). 
 
It is expected the subjects will attend all scheduled study visits. Should a subject be unable to 
participate in an in-person visit, wound assessments and solicitation of AEs may be performed 
by telemedicine/video interactions. However, no assessment of wound re-epithelialization nor 
observation or confirmation of closure may be performed via video/telemedicine visits. These 
wound assessments may be performed only during a face-to-face visit. 
 
Clarification that only certain 
activities may be performed via 
telephone or video conferencing. 

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Protocol Section  Removed text is strikethrough and added text is bold  
Issue/rationale for change  
Section 11.9.1.5 
An adverse event of special interest (serious or nonserious) is one of scientific and medical concern 
specific to the sponsor’s product or program, for which ongoing monitoring and rapid communication 
by the Investigator to the sponsor can be appropriate. AESI will be reported using the SAE/AESI 
Report Form and observe the same reporting timeline (Table 6). For this study, Adverse Events of 
Special Interest (AESI) include: 
• 
Signs/symptoms of endotoxin reaction (ie, combination of hypo/hyperpyrexia, 
hypo/hypertension tachycardia, tachypnea and change in mental status) within 24 hours 
after StrataGraft application 
• 
Unexpected or unusual infections 
• 
Dermatological malignancy 
• 
Other transplantation related adverse events or clinical events that are suspicious of a 
xenogeneic cause, e.g. disease/disorder of known zoonotic origins 
Reflects modifications of the 
xenotransplantation product 
requirements for StrataGraft as 
granted by the US FDA.