Clinical trial NCT05386368
Conditions: Carbon Dioxide Laser Photoaging
Keywords: Laser Facelift
Sponsor: Wake Forest University Health Sciences
Start date: 2023-03-22; Completion date: 2024-05-06
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To determine whether following Carbon dioxide (CO2) laser treatment, application of autologous cell suspension obtained via enzymatic and mechanical preparation will reduce negative side effects from CO2 laser and decrease the time of healing following treatment.

Detailed description:
The perioral area of the face will be treated with CO2 laser. Laser setting will be determined by the treating surgeon for each individual patient. Typical settings to be used for severe facial photoaging is Energy (mj) 100-125, Scan Size 6-7 mm, Density 2-3, Hertz 100-200, Repeat Delay 0.3-1.5 seconds, number of passes 2. The patient would be randomized and blinded to either left perioral or right perioral RECELL application. The surgeon would also be blinded to which side received RECELL treatment or Placebo (saline spray). Randomization would occur before study initiation with subjects assigned either left perioral or right perioral RECELL treatment based on their subject enrollment number. The study team member who prepares and blinds the RECELL will create the list of subject ID numbers with subject ID number randomly assigned to either left perioral or right perioral treatment group. This will be completed prior to any patient enrollment in the study. This spreadsheet will be password protected and only accessible to study coordinators and the team member responsible for preparing RECELL.

Arms: arm 1: Right perioral area of face receives ReCell/ Left receives saline arm 2: Left perioral area of face receives ReCell/ Right receives saline
Interventions: intervention 1: ReCell
Intervention descriptions: intervention 1: The perioral area of the face will be treated with CO2 laser. Randomization would occur before study initiation with subjects assigned either left perioral or right perioral RECELL treatment based on their subject enrollment number. The study team member who prepares and blinds the RECELL will create the list of subject ID numbers with subject ID number randomly assigned to either left perioral or right perioral treatment group. This will be completed prior to any patient enrollment in the study. Intraoperatively, RECELL and Placebo will be provided to surgeons and assistants in opaque application devices prepared by a trained, designated study team member.

Both the treatment and placebo sides, will be dressed with a standard autologous cell suspension post treatment dressing (Telfa Clear and Xeroform).

Protocol documents:
Prot_SAP_001.pdf: 
 
 
1 
 
 
 
Application of RECELL to Promote Healing Following CO2 Laser 
Treatment in Cosmetic Facelift Patients 
 
IRB00085278 
 
NCT05386368 
 
IRB Approval Date:  05/04/2023 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
2 
Study Title: Application of RECELL to Promote Healing Following CO2 Laser Treatment in 
Cosmetic Facelift Patients  
 
Principal Investigator:  Joseph Molnar, MD, PhD  
 
Co-investigator(s): Ramon Llull, MD, PhD, Anthony DeFranzo, MD, Christopher Runyan, MD, 
Robert Siska, MD, Abby Peoples, BA, Caitrin Curtis, MD, Amelia Davidson, BS  
 
Sponsor or funding source: Department of Plastic and Reconstructive Surgery, RECELL 
product provided by Avita Medical 
 
Background, Rationale and Context 
 
The RECELL system is a regenerative epidermal harvesting device that is currently FDA 
approved for use in treatment of partial thickness burns in adults. The system works by 
enzymatically processing a small sample of the patient’s skin to create a regenerative epidermal 
suspension (RES) graft that can be sprayed onto a burn wound. Contained within the RES is a 
mix of keratinocytes, fibroblasts, and melanocytes.1,2 The advantage of using the RECELL 
system over traditional skin grafting techniques is that, when enzymatically processed, donor 
tissue can be applied to re-epithelialize a significantly larger area than traditional skin grafting 
techniques. RES usually allows an 80:1 donor site to graft site expansion ratio.3,4   
 
While RES has been most extensively used in burn treatment, it has also been used with success 
following CO2 laser resurfacing for the treatment of vitiligo and for enhanced healing following 
microdermabrasion.5,6 A decade of precedent exists for treating patients with vitiligo through a 
combination of CO2 laser and regenerative epidermal suspension grafting with the goal of 
improved skin pigment after re-epithelialization.7 A 2019 study assessed the healing time with 
and without RECELL application in 78 patients undergoing microdermabrasion for acne scare 
treatment. They study found a statistically significant decrease in healing time between the two 
groups, with the RECELL group (n = 48) healing in an average of 5.27 days and the group with 
microdermabrasion alone (n= 30) healing in an average of 12.3 days; healing time was defined as 
total epithelialization duration.8   
 
With the safety and efficacy of RES demonstrated in multiple clinical contexts, our study aims to 
ascertain if RES can be used for cosmetic purposes to enhance healing following CO2 partial 
field ablation. CO2 laser resurfacing is often used as an adjunct treatment during facelift 
procedures to address signs of aging in the periorbital and perioral areas. The laser treatment 
works by a superficial layer of the skin, requiring complete reepithelialization of laser treated 
areas. This process results in significant post-operative erythema, pain, and downtime for the 
patient. During the facelift procedure, excess skin is removed and discarded. In our proposed 
study, this excess skin would be repurposed via processing with the RECELL system to be used 
as a regenerative epidermal suspension graft on CO2 laser treated areas. The excess skin 
removed on a facelift is a greater surface area than the required 2 x 3 skin graft that is required 
for the common 80:1 expansion used in burn surgery. Therefore, we should have significant 
amounts of excess skin that could be repurposed as a split thickness skin graft that can be used 
for the recell. There will not be any additional skin removed further than what is required for the 


 
 
3 
facelift. We will use an 0.008 inch Weck blade to repurpose the excess skin into a split thickness 
skin graft need for the recell.  
 
 
Device Output Characterization 
We do not have any plans for this.  
 
Objectives 
The primary objective and study endpoint will be safety. The number of skin reactions will be 
evaluated to measure the primary endpoint over the treated area vs placebo control.  
 
Methods and Measures 
 
Design 
Randomized, Double Blind, Placebo Controlled  
 
Setting 
Atrium Health Wake Forest Baptist Department of Plastic and Reconstructive 
Surgery 
 
Subjects selection criteria 
 
• Inclusion Criteria 
Adults 22 years or older  
Patients undergoing facelift with perioral CO2 laser treatment  
Skin that is Fitzpatrick Score 1 or 2 
 Subjects who are in general good health 
Subjects who fully understand the research nature of this study and sign the 
informed consent 
  
• Exclusion Criteria 
Prior perioral CO2 laser resurfacing  
Allergy to components of preparation system 
Subjects who have cosmetic or surgical treatment in perioral area within 3 months 
before the study (including laser, chemical peels, fillers, botulinum toxin). 
Subjects with existing open wounds on the face 
Subjects with active cutaneous infection, acne, dermatitis or any active dermal 
disease on the face 
Subject with signs of hypersensitivity or inflammation on the face 
Subjects with known hypersensitivity to trypsin or compound sodium lactate 
solution (Hartmann’s Solution) 
Subjects with known hypersensitivity to anesthetics, adrenaline/epinephrine, 
povidone-iodine, or chlorhexidine solutions. 
Subjects with any disease/condition that may affect wound healing such as 
diabetes or obesity 
Subjects with any bleeding disorder  


 
 
4 
Subjects with any existing malignancy  
Subjects who are pregnant, breastfeeding, or whose urinary pregnancy test is 
positive before participation in the study 
Subjects with any disease/condition deemed unsuitable for facelift surgery or 
RECELL treatment by the treating physician 
 
• Sample Size 
10 patients 
 
Interventions and Interactions 
 
The perioral area of the face will be treated with CO2 laser. Laser setting will be determined by 
the treating surgeon for each individual patient. The laser is a Lumenis Ultrapulse/Surgitouch 
CO2 laser, 510(k) Number K030147. A laser (light amplification by stimulated emission of 
radiation) based device having coherence, collimated and typically monochromatic radiation. 
Typically indicated to cut, destroy, remove or coagulate tissue, generally soft tissue, for general 
surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, 
podiatry, otolaryngology (ent), gynecology, neurosurgery, orthopedics (soft tissue), dental and 
oral surgery, and dentistry. The classification regulation 21 cfr 878.4810 describes a device that 
is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.   
This laser is typically used in our practice for skin resurfacing to reduce the signs of aging, 
improve skin texture, laxity and tone, and reduce scars and stretch marks. Typical settings to be 
used for severe facial photoaging with Total FX is: Active FX,  Energy (mj) 100-125, Scan Size 
6-7 mm, Density 2-3, Hertz 100-200, Repeat Delay 0.3-1.5 seconds, number of passes 2. Deep 
FX,  Energy (mj) 12.5-22.5, Scan Size 10 mm, Density 5-20%, Hertz 300-600, Repeat Delay 
0.3-1.5 seconds, Number of Pulses 1-2, number of passes 1-2.    The patient would be 
randomized and blinded to either left perioral or right perioral RECELL application. The surgeon 
would also be blinded to which side received RECELL treatment or Placebo (saline spray). 
Randomization would occur before study initiation with subjects assigned either left perioral or 
right perioral RECELL treatment based on their subject enrollment number. The study team 
member who prepares and blinds the RECELL will create the list of subject ID numbers with 
subject ID number randomly assigned to either left perioral or right perioral treatment group. 
This will be completed prior to any patient enrollment in the study. This spreadsheet will be 
password protected and only accessible to study coordinators and the team member responsible 
for preparing RECELL. 
  
RECELL® is a single-use, stand-alone, battery-operated, regenerative epidermal harvesting 
device containing enzymatic and delivery solutions, sterile surgical instruments, and actuators. 
The cell suspension contains a mixed population of cells, including keratinocytes, fibroblasts, 
and melanocytes, obtained from the disaggregation of the skin sample.  The Enzyme used to 
process the cells is a biological agent and as such may have slight variations in color and texture. 
The enzyme is derived from animal tissue and has undergone filtration and terminal sterilization 
by gamma irradiation.  
 
Intraoperatively, RECELL and Placebo will be provided to surgeons and assistants in opaque 
application devices prepared by a trained, designated study team member.  


 
 
5 
 
Both the treatment and placebo sides, will be dressed with a standard regenerative epidermal 
suspension post treatment dressing (Telfa Clear and Xeroform). Xeroform will be removed on 
postoperative day 1. Telfa clear will be removed on postoperative day 7. Patients will return to 
clinic for follow up at the following interval:  
• Post Operation Day 1 
• Post Operation Day 7 
• Post Operation Day 14 
• 1-month Post Operation 
• 2-months Post Operation 
• 3-months Post Operation 
 
There is always a chance the patient may need to be withdrawn from the study. The main 
consideration for stopping is the dressings, as the Recell will already be sprayed. If the patient 
cannot tolerate the dressings, we will stop and remove them from the study.  Otherwise, we will 
deal with complications similar to how we would deal with other laser reactions- local wound 
care, anti-virals, etc.  
 
Any signs of anaphylactic events will lead to the study stopped immediately and unbinding. We 
will immediately wash the cell suspension off of the face with 3 liters of normal saline (NS) 
while treating the anaphylaxis per institutional protocol (including submuscular epinephrine).  
 
Any high incidence of serious adverse events (any serious adverse event, including severe 
infection requiring return to the operating room) will warrant early unbinding and assessment of 
safety immediately.  
 
Subjects will be able to withdraw from the study for any reason and at any time. We can remove 
the cell suspension with removal of dressings and 3 liters of NS wash.   
 
  
Outcome Measure(s) 
 
Preoperatively patient baselines will be established with standardized studio photographs, and 
photos using the Quantificare LifeViz® Camera, as well as in person evaluation.  
 
Intraoperatively, the patient will be photographed in CO2 treated areas with the Quantificare 
LifeViz® Camera and standardized photography. This camera measures lines, closing surfaces, 
volume, depth, and perimeter of the skin surface for microstructure analysis. We will analyze 
this data to track progress throughout the study. 
 
Postoperatively, patients will be evaluated at each visit via in person evaluation by the surgeon, 
as well as using standardized photography, Quantificare LifeViz® Camera photos, 
administration of applicable FACE-Q scales (patient completed survey), and pain score (standard 
1-10 pain scale).  Please find FACE-Q scales in Appendices B-H.  
 
Please find study calendar in Appendix A.  
 


 
 
6 
Analytical Plan 
Results will be analyzed initially using descriptive statistics.  Comparison between groups will 
be done using Fisher’s exact tests for proportions, and t-tests or ANOVA procedures for 
continuous variables.  Regression analysis will be performed to identify independent outcome 
predictors.  Other inferential statistical analysis will be conducted as appropriate. 
 
Human Subjects Protection 
Collection of patient-identifying information will be limited to what is necessary to conduct 
analysis that is accurately linked to a given subject. Other than the master ‘linkage’ file, patient 
names, and medical record numbers will be removed and subjects will be associated with an 
abstracted unique Study ID. DOB will only be collected in order to dynamically calculate age at 
operative and follow up time points. Data will be stored electronically on the Wake Forest 
School of Medicine’s secure REDCap server, a HIPAA-compliant web platform.  Information 
for each subject will be entered directly from EPIC to the secure REDCap database, so data will 
not be stored on portable storage devices (including USB drives). In addition to study informed 
consent, photography consent will be obtained.  
 
 
 
Subject Recruitment Methods 
Patients who are scheduled to undergo elective facelift surgery with perioral CO2 laser 
resurfacing will be identified in the Plastic Surgery Clinics at both Janeway Tower and Vest Mill 
office locations. Any patient meeting inclusion criteria will be recruited during preoperative 
planning. Patients will have study information provided by a qualified study team member. 
There will be no compensation provided for this study, but the laser will be offered at no cost for 
participants.   
 
Informed Consent 
Informed consent will be obtained by approved study personnel after study purpose, duration, 
interventions, benefits and risks are thoroughly discussed with the subject. After the entire 
consent has been reviewed and all questions have been answered, potential subjects will be given 
the option to participate. A copy of the signed and dated consent form will be given to each 
enrolled subject and one placed on the chart. The original will be kept with research study 
records. In addition, a consent for photography and photograph use in research and publication 
will be obtained and placed in the chart prior to study participation. Please see a copy of 
Informed Consent in Appendix I.  
 
Confidentiality and Privacy 
Confidentiality will be protected by collecting only information needed to conduct outcomes 
research and related research to improve facelift and CO2 laser resurfacing outcomes. All 
database data will be entered into the Wake Forest School of Medicine’s secure REDCap server. 
To help ensure subject privacy and confidentiality, a linkage file will be maintained containing 
each patient’s medical record number and unique REDCap ID. Patient names will not be 
maintained in this file. The linkage file will be stored separately from the data available to 
researchers and will be kept secure, with access limited to designated study personnel. Data 
access will be limited to study staff.  Data and records will be kept locked and secured, with any 


 
 
7 
computer data password protected.  No reference to any individual participant will appear in 
reports, presentations, or publications that may arise from the study however patient photographs 
may appear in publications with patient consent.  
 
Data and Safety Monitoring 
The principal investigator will be responsible for the overall monitoring of the data and safety of 
study participants.  The principal investigator will be assisted by other members of the study 
staff. 
Additional safety assessment will include a full medical history and physical before proceeding 
with study activities.  
 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
Adverse events would include the inability to tolerate dressings, deeper burns - including 
blistering burns or full-thickness burns - which would be managed with local wound care as we 
would manage any other burn in our burn center. We will record any viral outbreaks and any 
need for antivirals (such as HSV outbreaks from burn or recell). Given the fact that we are doing 
a controlled burn, the adverse outcome for "burns," will be blistering burn, signifying a deeper 
than expected burn from the laser. 
We will assess for adverse events at each follow-up visit.  Follow-up visits will include 
photography and assessment for adverse events.  
Any unanticipated problems, serious and unexpected adverse events, deviations or protocol 
changes will be promptly reported by the principal investigator or designated member of the 
research team to the IRB and sponsor or appropriate government agency if appropriate. 
We will report all adverse events to the FDA as described in 21 CFR 312.32. 
 
 
Risk Analysis 
Given that Recell is a product that speeds up wound healing, we do not anticipate that it will 
lengthen the wound healing course for the laser.  
 
 
 
References  
1.  
Hirobe T. Keratinocytes regulate the function of melanocytes. Dermatologica Sin. 
2014;32(4):200-204. doi:10.1016/J.DSI.2014.05.002 
2.  
Wood F, Giles N, Stevenson A, Rea S, Fear M. Characterisation of the cell suspension 
harvested from the dermal epidermal junction using a ReCell® kit. Burns. 2012;38(1):44-
51. doi:10.1016/J.BURNS.2011.03.001 
3.  
Holmes IV J, Molnar J, Carter J, et al. A Comparative Study of the ReCell® Device and 
Autologous Spit-Thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries. J 
Burn Care Res. 2018;39(5):694-702. doi:10.1093/JBCR/IRY029 
4.  
Holmes J, Molnar J, Shupp J, et al. Demonstration of the safety and effectiveness of the 
RECELL ® System combined with split-thickness meshed autografts for the reduction of 
donor skin to treat mixed-depth burn injuries. Burns. 2019;45(4):772-782. 
doi:10.1016/J.BURNS.2018.11.002 
5.  
Lommerts JE, Meesters AA, Komen L, et al. Autologous cell suspension grafting in 


 
 
8 
segmental vitiligo and piebaldism: a randomized controlled trial comparing full surface 
and fractional CO2 laser recipient-site preparations. Br J Dermatol. 2017;177(5):1293-
1298. doi:10.1111/bjd.15569 
6.  
Ren J, Liu J, Yu N, et al. The use of noncultured regenerative epithelial suspension for 
improving skin color and scars: A report of 8 cases and review of the literature. J Cosmet 
Dermatol. 2019;18(5):1487-1494. doi:10.1111/jocd.13071 
7.  
Van Geel N, Wallaeys E, Goh BK, De Mil M, Lambert J. Long-term results of 
noncultured epidermal cellular grafting in vitiligo, halo naevi, piebaldism and naevus 
depigmentosus. Br J Dermatol. 2010;163(6):1186-1193. doi:10.1111/j.1365-
2133.2010.10014.x 
8.  
Chen Q, Yu N, Liu Z, et al. The Clinical Efficacy of ReCell® Autologous Cell 
Regeneration Techniques Combined with Dermabrasion Treatment in Acne Scars. 
Aesthetic Plast Surg. 2020;44(2):535-542. doi:10.1007/s00266-019-01481-8 
 
Appendix 
A. Study Calendar  
B. Preoperative Scale 
C. FACE-Q POD 1 Scales 
D. FACE-Q POD 7 Scales  
E. FACE-Q POD 14 Scales 
F. FACE-Q 1 Month Scales  
G. FACE-Q 2 Month Scales  
H. FACE-Q 3 Month Scales  
I. Informed Consent – Created following final protocol approval 
J. Photography Consent – standard departmental photography consent  

ICF_002.pdf: 
IRB00085278
RECELL Following CO2 Laser Treatment in Cosmetic Patients
NCT05386368
IRB Approval Date:  06/28/2023


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Adult Consent Form
IRB Template Version 3/1/2022
Informed Consent
RECELL FOLLOWING CO2 LASER TREATMENT IN COSMETIC 
PATIENTS
Informed Consent Form to Participate in Research
Joseph Molnar, MD, PhD, Principal Investigator
SUMMARY
You are invited to participate in a research study. The purpose of this research is to determine if 
RECELL® regenerative epidermal harvesting device can accelerate wound healing in the setting 
of facial rejuvenation. The system works by processing a small sample of your healthy skin to 
create a Regenerative Epidermal Suspension (RES) graft that can be sprayed onto an area for 
treatment.  You are invited to be in this study because you are planning to undergo a face lift 
combined with CO2 laser resurfacing. Participation in this study will involve you undergoing 
your planned face lift and CO2 laser resurfacing. Your participation in this research will involve 
3-5 visits and last about 3 months.
At the time of the procedure, the surgeon will use tissue from your facelift procedure in the 
RECELL® regenerative epidermal harvesting process. The RECELL® Regenerative Epidermal 
Suspension (RES) will then be sprayed onto the skin around your mouth after the resurfacing 
with the CO2 laser. You will follow up with your surgeon as planned. During your follow up 
appointments, your wound healing will be documented via photographs and a patient survey. 
RECELL® is currently FDA approved for use in burn care, including direct application to acute 
partial-thickness thermal burn wounds or application with meshed autografting for acute full-
thickness thermal burn wounds. All research studies involve some risks. Adverse effects 
associated with RECELL® use in burn care are typical of care and treatment of burns and 
include swelling, blistering, infection, pain, scarring, inflammation of hair follicles, skin 
irritation, redness, itching, and delayed healing. An additional risk to this study that you should 
be aware of is there may be an unequal rate of wound healing on your perioral region.  You may 
or may not benefit from participation in this study.  
Your participation in this study is voluntary.  You do not have to participate in this study if you 
do not want to. You will not lose any services, benefits, or rights you would normally have if you 
choose not to participate. 
The remainder of this form contains a more complete description of this study. Please read this 
description carefully. You can ask any questions if you need help deciding whether to join the 
Department/Section of Plastic and Reconstructive Surgery
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00085278
Meeting Date Approved 6/28/2023          
Version Valid Until: 6/27/2024


Page 2 of 9
Adult Consent Form
IRB Template Version 3/1/2022
study. If you have questions, suggestions, or concerns regarding this study or you want to 
withdraw from the study please contact the Principal Investigator at 
. 
If you have any questions, suggestions or concerns about your rights as a volunteer in this 
research, contact the Institutional Review Board at 
 or the Atrium Health Wake 
Forest University School of Medicine Research Subject Advocate at 
.
Introduction
You are invited to be in a research study. Research studies help scientists learn new information 
that may help other people in the future. You are being asked to be in this study because you are 
electing to undergo face lift and CO2 laser resurfacing. Your participation is voluntary. You do 
not have to be a part of this study if you do not want to.  Please take your time in making your 
decision if you would like to join. Ask your study doctor or the study staff to explain any words 
or information contained in this informed consent document that you do not understand. You 
may also discuss the study with your friends and family.
Why Is This Study Being Done?
The purpose of this research study is to determine if RECELL® regenerative epidermal 
harvesting can accelerate wound healing when applied following face lift and CO2 laser 
resurfacing. 
RECELL® regenerative epidermal harvesting has been approved by the US Food and Drug 
Administration (FDA) for use in burn care, specifically for direct application to acute partial-
thickness thermal burn wounds or application in combination with meshed autografting for acute 
full-thickness thermal burn wounds. However, it has not been approved for use following CO2 
laser resurfacing. 
In this study, RECELL® will be applied to the perioral region. A placebo will be used in the 
region that is not receiving RECELL®. A placebo is a substance that is not thought to have any 
effect on your disease or condition. Placebos are used in research studies to see if the drug being 
studied really does have an effect.
How Many People Will Take Part in the Study?
Ten people at one research site will take part in this study. 
What Is Involved in the Study?
At your first study visit, standardized studio photographs and photos using the Quantificare 
LifeViz® Camera will be obtained.
You will be randomized into one of two study groups; (A) Right perioral area receives 
RECELL®/Left receives Placebo or (B) Left perioral area receives RECELL®/ Right receives 
Placebo . Randomization means that you are put into a group by chance. It is like flipping a coin. 
Neither you nor the investigator will know which area of your face will be receiving RECELL® 
(right perioral or left perioral). This is done so that a fair evaluation of results can be made. This 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00085278
Meeting Date Approved 6/28/2023          
Version Valid Until: 6/27/2024


Page 3 of 9
Adult Consent Form
IRB Template Version 3/1/2022
information is available to the researchers if needed in an emergency.
You will undergo your scheduled facelift and CO2 laser resurfacing as planned. During the 
procedure, the excised tissue from the facelift will be used as donor tissue for the RECELL® 
regenerative epidermal harvesting Device. Those in group A will be sprayed with RECELL® on 
the right perioral area and sprayed with placebo on the left side. Those in group B will be 
sprayed with RECELL® on the left perioral area and sprayed with placebo on the right side.
Intraoperatively, the patient will be photographed in CO2 treated areas with the Quantificare 
LifeViz® Camera and standardized photography.
Both the treatment and placebo sides will be dressed with a standard regenerative epidermal  
suspension post treatment dressing (Telfa Clear and Xeroform). Xeroform will be removed on 
postoperative day 1. Telfa clear will be removed on postoperative day 7. Patients will return to 
clinic for follow up at the following interval: 

Post Operation Day 1

Post Operation Day 7

Post Operation Day 14

1-month Post Operation

2-months Post Operation

3-months Post Operation
Postoperatively, patients will be evaluated at each visit via standardized photography, 
Quantificare LifeViz® Camera photos, a patient completed survey, and pain score (standard 1-10 
pain scale).  
As part of this research study, you will be photographed.  This is being done in order to 
document wound healing. You understand that you may request the photography to stop at any 
time during the course of the research study. You can also withdraw your consent to use and 
disclose the photograph before it is used. You should also understand that you will not be able to 
inspect, review, or approve the photographs, videotapes, audiotapes or other media (including 
articles containing such) before they are used in this study. 
Please choose one of the following regarding the use and disclosure of the photograph used in 
this research study:
_____ I would like the photographs of me to be destroyed once their use in this study is finished.
____ The photographs of me can be kept for use in future studies provided they are kept secure 
and any future study will be reviewed by an IRB.  I understand that I will not be able to inspect, 
review or approve their future use.
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00085278
Meeting Date Approved 6/28/2023          
Version Valid Until: 6/27/2024


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Adult Consent Form
IRB Template Version 3/1/2022
How Long Will I Be in the Study?
You will be in the study for about 3 months.
You can stop participating at any time. If you decide to stop participating in the study, we 
encourage you to talk to the investigators or study staff first. However, there is no consequence 
for withdrawal from the study. 
What Are the Risks of the Study?
Being in this study involves some risk to you. You should discuss the risk of being in this study 
with the study staff. The risks of facelift and laser resurfacing should be discussed with your 
physician. 
RECELL® is currently FDA approved for use in burn care, including second degree burns and 
skin grafts for third degree burn wounds. Adverse effects associated with RECELL® use in burn 
care are typical of care and treatment of burns and include swelling, blistering, infection, pain, 
scarring, inflammation of hair follicles, skin irritation, redness, itching, and delayed healing. 
The application of RECELL® following CO2 laser has not been studied, so there may be some 
risks that we cannot predict. You should tell the research staff about all the medications, vitamins 
and supplements you take and any medical conditions you have. This may help avoid side 
effects, interactions and other risks. A potential risk that you assume by participating in this 
study is an unequal rate of wound healing between your right and left perioral areas. 
Taking part in this research study may involve providing information that you consider 
confidential or private.  Efforts, such as coding research records, keeping research records secure 
and allowing only authorized people to have access to research records, will be made to keep 
your information safe.
Are There Benefits to Taking Part in the Study?
If you agree to take part in this study, there may or may not be direct benefit to you. We hope the 
information learned from this study will benefit other people in the future. The benefits of 
participating in this study may include faster healing in the area of your face that is sprayed with 
RECELL®. Because individuals respond differently to therapy, no one can know in advance if it 
will be helpful in your particular case.
What Other Choices Are There?
You do not have to be in this study. Instead of being in this study, you can choose to proceed 
with facelift and CO2 laser resurfacing without RECELL®.
What Are the Costs?
All study costs, including any study products or procedures related directly to the study, will be 
paid for by the study. Costs for your regular medical care, which are not related to this study, 
will be your own responsibility.
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00085278
Meeting Date Approved 6/28/2023          
Version Valid Until: 6/27/2024


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Adult Consent Form
IRB Template Version 3/1/2022
The RECELL® device is provided by Avita Medical/AHWFB Department of Plastic and 
Reconstructive Surgery. Neither you nor your insurance company will be billed for the 
investigational device.  You and/or your insurance company will not be billed for the cost of any 
surgical procedure(s) necessary to apply the RECELL® regenerative epidermal  suspension. 
WILL YOUR RESEARCH RECORDS BE CONFIDENTIAL?
The results of this research study may be presented at scientific or medical meetings or published 
in scientific journals.  Your identity and/or your personal health information will not be disclosed 
unless it is authorized by you, required by law, or necessary to protect the safety of yourself or 
others.  
Your information may be provided to Federal and other regulatory agencies as required.  The 
Food and Drug Administration (FDA), for example, may inspect research records and learn your 
identity if this study falls within its jurisdiction.
Will You Be Paid for Participating?
You will not be paid for taking part in this research study. 
WHO IS SPONSORING THIS STUDY?
This study is being sponsored by the Department of Plastic and Reconstructive Surgery. The 
sponsor is providing the RECELL® Device to the researchers to help conduct this study. The 
researchers do not hold a direct financial interest in the sponsor or the product being studied.
What About My Health Information?
In this research study, any new information we collect from you and/or information we get from 
your medical records or other facilities about your health or behaviors is considered Protected 
Health Information. The information we will collect for this research study includes: Name, age, 
sex, medical and surgical history, medications, history of smoking, alcohol or drug use. 
Laboratory test results and other clinically relevant medical reports created as a result of your
participation in the research study may be entered into the computer systems of Atrium Health,
Wake Forest University Health Sciences, and/or their respective affiliated entities. These results
and reports will be kept secure in compliance with applicable laws, with permission to access 
this information limited to individuals with proper authority, but who may not be directly 
involved with this research study.
A medical record will be created for all study participants seen on-site and if a medical record
doesn’t already exist. Information about your participation in the study will be placed in the 
medical record, along with any routine medical test results that were obtained as part of this 
study.
If this research study involves the diagnosis or treatment of a medical condition, then your 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00085278
Meeting Date Approved 6/28/2023          
Version Valid Until: 6/27/2024


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Adult Consent Form
IRB Template Version 3/1/2022
medical record will indicate that you are participating in this study and Protected Health 
Information collected from you may be placed in your medical record, and may be used to help 
treat you, arrange payment for your care, or assist with Medical Center operations. If you are not 
a patient at this Medical Center, a medical record will be created for you to ensure that this 
important information is available to doctors in case of an emergency.  This part of the medical 
record will only be available to people who have authorized access to your medical record.  
We will make every effort to keep your Protected Health Information private. We will store 
records of your Protected Health Information in a cabinet in a locked office or on a password 
protected computer. 
Your Protected Health Information or information that identifies you may be given to others 
during and after the study. This is for reasons such as to carry out the study, to determine the 
results of the study, to make sure the study is being done correctly, to provide required reports 
and to get approval for new products.  
Some of the people, agencies and businesses that may receive and use your health information 
are the research sponsor; representatives of the sponsor assisting with the research; investigators 
at other sites who are assisting with the research; central laboratories, reading centers or analysis 
centers; the Institutional Review Board; representatives of your healthcare facility; 
representatives from government agencies such as the Food and Drug Administration (FDA) or 
the Office of Human Research Protections (OHRP), the Department of Health and Human 
Services (DHHS) and similar agencies in other countries.
Some of these people, agencies and businesses may further disclose your health information. If 
disclosed by them, your health information may no longer be covered by federal or state privacy 
regulations.  Your health information may be disclosed if required by law. Your health 
information may be used to create information that does not directly identify you. This 
information may be used by other researchers. You will not be directly identified in any 
publication or presentation that may result from this study unless there are photographs or 
recorded media which are identifiable.
Monitors, auditors, IRB or other regulatory agencies will be granted direct access to the 
participant’s original medical record for verification of clinical trial procedures or data, without 
violating confidentiality of the participant and to the extent permitted by other applicable laws.
If required by law or court order, we might also have to share your Protected Health Information 
with a judge, law enforcement officer, government agencies, or others. If your Protected Health 
Information is shared with any of these groups, it may no longer be protected by federal or state 
privacy rules.
Any Protected Health Information collected from you in this study that is maintained in the 
research records will be kept for at least six years after the study is finished. At that time any 
research information not already in your medical record will either be destroyed or it will be de-
identified. You will not be able to obtain a copy of your Protected Health Information in the 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00085278
Meeting Date Approved 6/28/2023          
Version Valid Until: 6/27/2024


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Adult Consent Form
IRB Template Version 3/1/2022
research records until all activities in the study are completely finished. 
You can tell Joseph Molnar, MD that you want to take away your permission to use and share 
your Protected Health Information at any time by sending a letter to this address:
Joseph Molnar, MD 
However, if you take away permission to use your Protected Health Information you will not be 
able to be in the study any longer. We will stop collecting any more information about you, but 
any information we have already collected can still be used for the purposes of the research 
study.
By signing this form, you give us permission to use your Protected Health Information for this 
study.
What Happens If I Experience an Injury or Illness as a Result of 
Participating in this Study?
Wake Forest University Baptist Medical Center maintains limited research insurance coverage 
for the usual and customary medical fees for reasonable and necessary treatment of injuries or
illnesses to some participants in certain research studies. To the extent research insurance
coverage is available under this policy, the reasonable costs of these necessary medical services
will be paid, up to a maximum of $25,000. To the extent research coverage is not available, you 
or your insurance company may be charged for the costs of medical care. You may receive care 
at Wake Forest University Baptist Medical Center and/or Atrium Health.
If you are injured, the insurer may require information such as your name, social security 
number, and date of birth in order to pay for your care. This is because the insurer is required by 
law to report any payments made to cover the care of any persons who are members of a 
government insurance plan to the Department of Health and Human Services.
You do not give up any legal rights as a research participant by signing this consent form. For
more information on medical treatment for research related injuries or to report a study related
illness, adverse event, or injury you should call Joseph Molnar MD at 
 or after 
hours 
.
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00085278
Meeting Date Approved 6/28/2023          
Version Valid Until: 6/27/2024


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What Are My Rights as a Research Study Participant?
Taking part in this study is voluntary. You may choose not to take part or you may leave the 
study at any time. Refusing to participate or leaving the study will not result in any penalty or 
loss of benefits to which you are entitled. If you decide to stop participating in the study we 
encourage you to talk to the investigators or study staff first to learn about any potential health or 
safety consequences. The investigators also have the right to stop your participation in the study 
at any time. This could be because it is in your best medical interest, your conditioned worsened, 
new information becomes available, you had an unexpected reaction, you failed to follow 
instruction, or because the entire study has been stopped.  Information that identifies you may be 
removed from the data or specimens that are collected as part of this study and could be used for 
future research or shared with others without additional consent. 
You will be given any new information we become aware of that would affect your willingness 
to continue to participate in the study.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law.  This website will not include information that can identify you.  At most, the 
website will include a summary of the results.  You can search this Web site at any time. 
WHOM DO I CALL IF I HAVE QUESTIONS OR PROBLEMS?
For questions about the study or in the event of a research-related injury, contact the study team 
at 
. If after hours, call 
.
The Institutional Review Board (IRB) is a group of people who review the research to protect 
your rights. If you have a question about your rights as a research participant, or you would like 
to discuss problems or concerns, have questions or want to offer input, or you want to obtain 
additional information, you should contact the Chairman of the IRB at 
 or the 
Research Subject Advocate at 
.
You will be given a copy of this signed consent form. 
Signatures
I agree to take part in this study. I authorize the use and disclosure of my health information as 
described in this consent and authorization form.  If I have not already received a copy of the 
Privacy Notice, I may request one or one will be made available to me.  I have had a chance to 
ask questions about being in this study and have those questions answered.   By signing this 
consent and authorization form, I am not releasing or agreeing to release the investigator, the 
sponsor, the institution or its agents from liability for negligence.
Subject Name (Printed):_____________________________
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00085278
Meeting Date Approved 6/28/2023          
Version Valid Until: 6/27/2024


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Adult Consent Form
IRB Template Version 3/1/2022
Subject Signature: _________________________________ Date: ________Time:_______ am pm 
Person Obtaining Consent (Printed):_____________________________
Person Obtaining Consent:___________________________ Date:_________ Time:________ am pm
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00085278
Meeting Date Approved 6/28/2023          
Version Valid Until: 6/27/2024