Clinical trial NCT04176705
Conditions: Burn Scar Skin Graft Scar
Keywords: Fractional laser Ablative Laser Carbon Dioxide Laser
Sponsor: Wake Forest University Health Sciences
Start date: 2020-12-14; Completion date: 2023-09-29
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Doctors and patients refer to all areas of skin changes from burn injury as burn scars. However, different areas of scars from burns can be treated differently. The burn scars that come from skin grafting surgery might be improved with laser treatment. The purpose of this study is to see if treating burn skin graft scars with a laser could make it better.

Fractional Ablative Laser has been approved by the US Food and Drug Administration (FDA), but it has not been approved for use in the early stages of scar maturation and is considered investigational for this study.

Detailed description:
This pilot study is being conducted to establish safety, however the study team will make multiple measures to measure for efficacy as well. The study team hypothesizes that human split-thickness skin grafts will safely respond similar to the porcine model when treated with the Fractional Carbon Dioxide (FxCO2) laser and have significantly less secondary contracture than control sites. The great majority of laser studies have addressed treatment of established scars. Ideally, treatment modalities could be moved into the acute period of injury, to shorten the recovery time of thermal burns by decreasing the time to maximum recovery, and mitigate scar formation. The current study will address the impact on treatment of skin graft applied in the treatment of acute burn wounds. Preliminary work completed by our team has confirmed that the red Duroc porcine model is a good model of hypertrophic scar formation in humans, and early use of the FxCO2 on split-thickness skin grafts decreased secondary contracture. Further, the study team has identified a period of 19 weeks between the time custom-made compression garments are ordered and actually applied with benefit to the patient. The study team has identified a "therapeutic donut hole" in which they have no efficacious alternative to offer until about 19 weeks. In these patients who had larger burn returning to the OR for additional procedures, the study team was able to offer FxCO2 treatment as a "salvage" therapy. With this, the study team has demonstrated safety for the skin graft and anecdotal efficacy. The study team proposes a pilot study to prospectively demonstrate safety in a controlled study and attempt to establish efficacy of early (post grafting day 7-10) FxCO2 laser treatment of split-thickness skin graft applied in the treatment of burn injuries.

Arms: arm 1: Split person design. Each participant had a skin burn area that was treated with the laser and a skin burn area that was not treated with the laser. arm 2: Split person design. Each participant had a skin burn area that was treated with the laser and a skin burn area that was not treated with the laser.
Interventions: intervention 1: Lidocaine Cream intervention 2: Triamcinolone Acetonide Cream intervention 3: Fractional Ablative Laser
Intervention descriptions: intervention 1: Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment. intervention 2: Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted. intervention 3: Applied to only site that is randomized to laser intervention

Protocol documents:
Prot_SAP_001.pdf: 
 
1 
 
Official Title:  Pilot Study of Early Postoperative Fractional Ablative Laser Treatment of Skin Grafts for Burns 
NCT04176705 
IRB-Approved Date: 12/30/20 
 


 
2 
 
 
              
 
 
Background: 
The near and long-term functional impact of burn 
scars and the sequelae of skin grafting are well known1. 
The economic burden of this treatment paradigm has also 
been recognized – with the monetary cost of treating burn 
sequelae estimated as over four times that of the in-hospital 
stays for acute burn injury2. In addition to the social and 
psychological burden, burn scars and the contraction of 
skin grafts can not only limit the range of motion (with a 
loss of function), but also lead to skeletal deformation (Fig. 
1). In addition, there has been increased appreciation of the 
incidence and importance of the impact of pruritus3,4.  The 
solution to these symptomatic and functional challenges is 
ongoing. 
 
Modern treatment of the burn patient is multidisciplinary 
and a wide array of management options are available (e.g. 
surgical release and skin grafting, local tissue 
rearrangement, compression garments, laser treatments, and 
steroid injections) to attempt to alter scar formation5,6. The 
paradigm of burn reconstruction (often referred to as a 
reconstructive ladder) reflects recognition of the 
heterogeneity of the problem and subsequent solution.  The 
overall strategy reflected in this metaphorical label is that 
the simplest solution deserves first consideration, and one 
proceeds to the next higher-level solution only when there 
is an identifiable contraindication to utilization of the first 
step (Fig. 2)7.  The rationale for a reasoned, stepwise 
approach is that the risk increases as a progressively higher-
level step is chosen.  As an extreme example, the use of a 
free flap to cover a second-degree burn is illogical.  The 
wound will predictably heal and the risk of the morbidity 
associated with flap loss is unacceptable.  Contrast the 
previous extreme example with a fourth degree burn 
involving exposed bone of sufficient size that there is not 
an alternative to achieving soft tissue coverage.  In the latter 
situation, the potential risk of free tissue transfer is logical 
in order to protect critical deep structures (bone, vessels, or 
nerves).  These steps can be selected for treatment of open 
wounds, as well as during reconstruction.    Just as there 
may be a better choice for coverage of an acute wound, 
there may also be a clear choice for improving function or 
appearance – while minimizing the risk to the patient.  The 
role of the fractional CO2 laser in modifying burn scars in 
not clear. Multiple authors have identified improvement in 
burns scars with treatment with fractional CO2 (FxCO2) laser treatment8-13.  However, a common critique is that 
 
Figure 1. Disabling burn scar, resulting from 
combination of delayed surgical treatment 
and rehabilitation treatment.  Fixed soft 
tissue deformities clinically apparent on 
inspection (A, C, and D) and X-ray of 
affected hand (B). 
 
 
Figure 2.  The reconstructive ladder (used 
for acute wound coverage or delayed 
reconstruction) is a metaphorical approach 
to reconstruction.  Each successive step is 
accompanied by increasing complexity and 
risk.  Understanding for the role of FxCo2 
treatment is incomplete. 


 
3 
measures were subjective, treatment timing and laser 
settings variable, and study populations were relatively 
small14.  The common approach to solving these 
challenges is to simply focus on planning a larger study.  
However, we note the lasers were also deployed as a 
solution to a quite heterogeneous problem. A common 
challenge to any clinical study is identifying the condition 
being treated as precisely as possible.  Although not 
commonly addressed, the term “burn scar” encompasses 
a heterogeneous group of pathologic skin changes 
associated not only with areas of burn that heal by 
secondary intention (forming scar), but also areas with 
thickened/shrunken skin grafts, hypertrophy at the seams 
along the edges of skin grafts, and delayed healing of skin 
graft donor sites with resultant hypertrophy (Fig.3).  The 
scarring and contracture of split-thickness skin grafts is 
expected without treatment.  Human split thickness skin 
grafts heal with secondary contracture, and this 
contracture can result in decreased function15.  Multiple 
factors have been noted to affect the amount of 
contracture- such as the use of meshed skin grafts or graft 
thickness16-18. The timing between injury and institution 
of both surgical and non-surgical means of treating scars 
is impactful as well.  Non-surgical methods of scar 
prevention are generally accepted to have increased 
effectiveness when applied closer to the time of injury6.  
Even in cases of simple primary closure of surgical 
wounds, mechanical intervention has been shown to be an effective means of decreasing scar formation, and 
these are applied immediately19,20.   Similarly, there is improved effectiveness of compression garments for 
managing burn scars if applied closer to the time of injury21.  These clinical observations appear consonant with 
animal studies of wounding which have confirmed the 
temporal changes in the wound environment and cellular 
architecture.  Surgical procedures are also affected by scar 
characteristics.  More immature scars show evidence of 
inflammation - greater vascularity, less pliability, and 
greater thickness of the tissue creates challenges that weigh 
against early release and graft or local tissue rearrangement 
(z-plasty).  In summary, the choices are about the best 
therapy and also the best time.  There have been clinical 
studies looking at the efficacy of both early versus delayed 
treatment strategies with FxCO2 laser.  However, early 
appears to mean a matter of months22.  This evolution in 
practice has left a critical time period poorly explored, 
especially with regards to the potential impact on burn 
scars – healing split-thickness skin graft in particular.  Of 
note, this pilot study does not seek to establish a new 
indication for the FxCO2 laser.  The FDA approves the 
laser in use at Wake Forest Baptist Medical Center.  It is 
approved for use on “surgical scars” (we are treating the 
resulting scars associated with skin graft surgery).  As mentioned, “burn scars” is a very inclusive term.  This is 
precisely why we will treat only the surgical scars related to burn treatment.  It is also approved for “other soft 
Figure 3.Examples of heterogeneity of 
pathology described as “burn scar”.  Include 
areas allowed to heal by secondary 
intention (A.), areas of contracted skin grafts 
(B.), scarring at the seams of supple full-
thickness skin grafts (C.) and even delayed 
healing with hypertrophy of donor sites (D.) 
 
 
Fig 4. Split-thickness skin graft contraction 
(Identified as “Scar Contraction”) is 
expressed as % original area as a function of 
time.  In this case, the sizes of the skin grafts 
were normalized to day 28 (the first day of 
laser treatment). 


 
4 
tissue applications”.  Finally, the laser is being applied in an earlier and earlier fashion as it use has become 
more popular and evolved.  The intent of this study is to establish safety and, perhaps efficacy, of use at a 
different time point.  
 
PRELIMINARY STUDIES (Conducted at The Ohio State 
University) 
Efficacy of Early Laser Treatment of Split-thickness Skin Grafts 
in a Porcine Burn Model: 
 Our group has documented the salutary effects of the 
FxCO2 laser treatment on a porcine model of split-thickness 
skin graft applied to excised burns23.  An unexpected finding 
was the improvement in eventual secondary contracture of the 
split-thickness skin graft (Figure 4.).  Although we also found 
improvement in measures important to skin graft appearance, 
the finding of reduced secondary contracture is particularly 
important to functional outcomes.  We have also conducted a 
pulse-chase study to better understand the effects of early (7 
days after grafting) FxCO2 treatment of split-thickness grafts in 
the same porcine burn model.  There was no evidence of slowed 
healing caused by laser treatment.  Healing was measured by 
transepidermal water loss, which is a functional measure of skin 
integrity (Fig. 5). 
 
Relevance to Proposed Clinical Trial: 
In Figure 3 B, the photo is of an axillary contracture created by tension from a skin graft, which underwent 
the normal, expected course of secondary contracture.  The photo is also intraoperative - from the surgical 
procedure necessary to correct the tension created by the secondary contracture.   The promise offered by the 
porcine model findings is that such corrective 
surgery of contracting skin grafts may be reduced 
in frequency, or avoided all together. Further, the 
animal model offers evidence of safety. 
 
Local Clinical Practice Cannot Provide Custom 
Compression Garments Sooner than 19 weeks 
from the time of injury: 
In an effort to better understand how 
measures such as compression therapy were being 
applied at our burn center, we conducted an IRB-
approved chart review to identify how long a delay 
exists between identification of the need for 
compression therapy and actual wearing by the 
patient.  The study has been submitted for 
publication and a surprising 19-week delay was 
identified (Table 1). 
 
Relevance to Proposed Clinical Trial 
 
Table 1.   A quality improvement project was translated 
into an IRB-approved review of the time required for 
patients to successfully don custom-made compression 
garments.  A surprising delay was noted.   
 
Figure 5.  When the porcine split-thickness 
skin graft (meshed 1:1.5) is treated with 
single pass of 70mJ at 5% fractional 
coverage, wound closure (defined by 
transepidermal water loss) is not retarded. 


 
5 
The noted delay was, and is, concerning from a clinical 
care perspective.  However, the clinicians have been unable to 
change the delays, as the process appears to have multiple 
logistical delays (therapist availability to measure, delays in 
ordering, delays in insurance approval, delays in fitting, delays in 
altering, and delays created by difficulty in contacting patient).  
These challenges notwithstanding, a unique opportunity has been 
created by the inability to offer a timely standard of care.  The 
delay offers an acceptable and ethical justification to apply early 
laser treatment to patients – either as part of clinical care or a 
prospective study. 
 
Limited Early Laser Treatment is Clinically Free of Complication 
 
Due to our inability to offer a timely and effective therapy to mitigate scar formation, our surgical team at 
the Ohio State University has treated skin grafts with FxCO2 during the period of initial hospital admission, when 
patients were returning to the OR for other procedures.  This has been offered as empiric therapy and not part of 
any type of study (Fig. 6).  With recognition of those limitations, 
the treatment is well tolerated, with no clinical evidence of graft 
injury (Fig. 6). Also, there is anecdotal appreciation of efficacy 
(Fig. 6 and Fig 7). We have applied the FxCO2 laser 
successfully in four patients.  We have seen no areas of 
unanticipated graft damage or loss related to its use.   
 
Relevance to Proposed Clinical Trial 
Safety is an essential concern of any proposed clinical trial.  
Although the experience of treating skin grafts at 6-10 days after 
surgery is limited at our Burn Center, it is promising. 
Establishing safety with an appropriately monitored study is an 
important unmet need. However, the preliminary data and 
qualitative observations are supportive that the study can be 
done safely. 
  
 
PROPOSED PILOT STUDY. 
 
This pilot study is being conducted to establish safety, however we will make multiple measures to 
measures of efficacy as well. We hypothesize that human split-thickness skin grafts will safely respond similar to 
the porcine model when treated with the FxCO2 laser and have significantly less secondary contracture than 
control sites. 
 
 
  
Overall Strategy 
 
Figure 6.  Skin grafts (meshed 1:1) on 
nearly entire dorsum of bilateral hands one 
day after fractional CO2 laser treatment. No 
subsequent loss of graft. Displayed flexion 
of digits at patient maximal effort. 
 
Figure 7. At time of presentation for third 
planned laser treatment (not yet wearing 
compression garments).  Note composite fists in 
A. 


 
6 
The great majority of laser studies have addressed treatment of established scars. Ideally, treatment modalities 
could be moved into the acute period of injury, to shorten the recovery time of thermal burns by decreasing the 
time to maximum recovery, and mitigate scar formation. 
The current study will address the impact on treatment of 
skin grafts applied in the treatment of acute burn wounds.  
Preliminary work completed by our team has confirmed 
that the red Duroc porcine model is a good model of 
hypertrophic scar formation in humans, and early use of 
the FxCO2 on split-thickness skin grafts decreased 
secondary contracture.  Further, we have identified a 
period of 19 weeks between the time custom-made 
compression garments are ordered and actually applied 
with benefit to the patient. We have identified a 
“therapeutic donut hole” in which we have no efficacious 
alternative to offer until about 19 weeks.  In these patients 
who had larger burn returning to the OR for additional 
procedures, we were able to offer FxCO2 treatment as a 
“salvage” therapy.  With this, we have demonstrated 
safety for the skin graft and anecdotal efficacy. We 
propose a pilot study to prospectively demonstrate safety 
in a controlled study and  attempt to establish efficacy of 
early (post grafting day 6-10) FxCO2 laser treatment of 
split-thickness skin graft applied in the treatment of burn 
injuries. 
 
Patient Eligibility 
All patients who are to undergo skin grafting procedures for acute treatment of thermal burns will be screened 
for enrollment.  Although, split-thickness skin grafts placed for reconstruction or coverage of non-burn injuries 
should be expected to heal and respond to treatment in a similar fashion to grafts on acute burn wounds, this 
study will seek to limit these variables and is focused on offering benefits to the acutely injury patient.  Only 
patients with grafts placed over at least 100cm2 will be approached for inclusion in the study so as to minimize 
any paracrine effect that might result from non-treated grafts in proximity of treatment areas.  The 100cm2 need 
not be contiguous.  That is to say, two smaller areas totaling 100cm2 can be used.  Sites will be randomized to 
laser/no laser. If there is a single site of sufficient size, it will 
be divided in to two, roughly equivalent surface area segments 
with the midpoint along the long axis of the 
limb/hand/foot/neck/torso (Fig. 8).  For site assignment 
purposes we will assume the classic anatomic position with 
patient assumed to be in a standing position, gaze forward, 
hands to sides with palms facing the direction of gaze. Areas 
will be labeled: A.(Right, cephalad, or lateral) and B. (left, 
caudad, or medial).  In order to attempt to assess the same 
three locations at each site, a tracing of each site will include a 
tracing of three, individual locations about 1 cm in 
(approximately) in diameter (Fig. 9). Any measures done at the 
time of treatment visits will be done prior to any therapeutic 
intervention. Both sites will have lidocaine 4% topical 
anesthetic cream (Ferndale Laboratories, Ferndale MI) applied 
as thin layer and left for 30-45 minutes to minimize discomfort 
(after any measurements have been taken).  The area to be 
treated (A. vs. B.) will be randomized with opening of an 
 
Figure 8.  Sites will be randomized such that the 
choice between treatment and control will be 
between A.(Right, cephalad, or lateral) and B. (left, 
caudad, or medial).  Extremities include the feet.  To 
avoid confusion regarding medial/lateral we will 
invoke convention of assuming body is in anatomic 
position (i.e. arms extended to the side with palms 
facing in direction of forward gaze of the patient. 
 
Figure 9. Tracings will be obtained of the 
perimeter of each site.  On the first set of 
tracings, we will mark three locations 
(approximately 1 cm in diameter) that will be 
used to help identify the same areas for 
subsequent measures and surveys. 


 
7 
evelope with assignment to treatment arm after the test sites have been identified.  The treatment area will then 
be cleaned with chlorhexidine gluconate solution 4.0% w/v (Mölnlycke Healthcare, Norcross, GA).  FxCO2 
laser treatment will then be completed with 5% fractional coverage and 70-mJ fluence setting (percentage of the 
total surface area ablated and the energy delivered in each micro-beam –respectively). We will apply 
triamcinolone acetonide (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml immediately after 
treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be 
part of the reason improvement is noted.   
For aftercare, patients will be instructed to apply a thin layer of an over-the-counter moisturizing cream such as 
Lubriderm® (Johnson and Johnson, Skillman, NJ) or Aveeno® (Johnson and Johnson, Skillman, NJ). 
 
Study Intervention and Group Assignment 
Sites will be labeled A and B in accordance with Figure 8.  For each patient, one site will be randomized 
to receive laser treatment and the other will be the control. The study statistician will generate a permuted block 
randomization scheme (three blocks of 5 cells). Treatment assignments will be delivered on-demand following 
confirmation of eligibility, patient consent, and identification of test sites. 
 
 
Study Outcome Assessment 
 
Measurements of scar properties, as 
illustrated in Fig. 10, will be made at the time of 
each treatment (immediately prior to treatment) 
and at two additional follow up time points. To 
assess changes in scar development and 
maturation in the control and treatment sites, scar 
appearance and properties will be assessed at 
each clinic visit using non-invasive methods and 
measurements.  Scars will be photographed at 
each session with a scale bar and color palette in 
each photograph so all images can be balanced to 
the same lighting conditions. Scar area at sites A 
and B will be traced onto transparent sheets and 
quantified 
using 
computerized 
planimetry 
following the same methodology used for our 
porcine studies23. The planimetry will also be 
used to digitally estimate graft loss (if any). To 
assess erythema and pigmentation, a Mexameter 
(Courage + Khazaka, Cologne, Germany) will be 
used to quantify the color of the treated and 
control scar. Scar biomechanics, pliability, 
elasticity and viscoelasticity, will be quantified 
using a BTC-2000(SRLI, Franklin, TN) as this 
instrument was shown to have the greatest inter- 
and intra-user reliability in our prior human 
studies.  Scar height and roughness will be quantified using a mold/casting technique using Aquasil Ultra XLV 
dental impression material (DENTSPLY International, Milford, DE) followed by mold imaging and quantitative 
analysis. In addition, the VSS and POSAS (Observer Scale only) will be performed by the research team members 
for scar color, mechanics, height and roughness. These measurements will be collected at each clinic visit (every 
1.5-3 months).  This data collection strategy has been optimized in adult burn patients at OSUWMC (IRB protocol 
#2016H0250) and requires no more than 25 minutes per patient. 
  
 
Figure 10.  Prior to each of three successive laser 
treatments, measures will be taken.  Photography, done at 
each visit, will be important to assessing qualitative graft 
changes, including monitoring for graft loss. Surveys will be 
given at the visit following a laser treatment (to asses for 
adverse events).  As the graft continues to heal, we expect 
measureable differences, color measurements (Mexameter), 
biomechanical measurements (BTC-2000), and casts with 
dental impression material will be taken.


 
8 
 
Clinical End Points: The primary endpoint for this pilot study is the contracture of scar (skin grafted) surface 
area at 90 days post-grafting.  A significant reduction in secondary graft contraction in the treatment group 
compared to the control group would prompt the design of a multi-center confirmatory trial.  Secondary endpoints 
include scar roughness, biomechanics as measured by stiffness and elasticity, redness measured by erythema each 
examined at 90 days post-grafting and VSS/POSAS scores along with patient reported satisfaction.  Additional 
secondary endpoints will include the examination of each measurement at mentioned above at 1 year post-grafting 
to examine longer term healing.  
 
Patient Eligibility: Eligible patients are non-emergent, patients with full-thickness burns who were seen at 
Wake Forest Baptist Medical Center and are scheduled for treatment with autografts for burn injury.   Inclusions 
criteria: ages 18- 89, autograft site of at least 100cm2 (not involving the head, neck, hands, buttocks or 
perineum).  All non-burn diagnosis (i.e. chronic wound, Steven-Johnsons/TEN, etc.) prisoners, pregnant 
women, and patients younger than 18 years will be excluded. 
 
Patient Identification: To screen for eligible patients, the operating room schedules and surgeons’ calendars will 
be reviewed by the clinical research coordinator (CRC), and the three burn surgeons will aid in identifying any 
potentially eligible adult (age 18-89) patient who is to undergo skin grafting of a full-thickness burn. After 
identification, study team personnel will then screen the patient for eligibility, by review of clinical information.  
 
Patient Recruitment:  Once eligible patients are identified, a qualified research team member will approach the 
patient and offer the opportunity to learn more about participation in this study.  If the patient is willing, then the 
qualified research team member will proceed to complete the informed consent and enrollment process. This will 
be completed at the conclusion of clinical care, to avoid any duress from the pain of wounds left open to the air.  
In the clinic, the process will be conducted in the patient’s exam room.  Similarly, inpatients will also be consented 
in the quiet of their hospital room so as to allow them time to carefully consider the details of the study and ask 
questions.  
 
Patient Sample Size and Rationale: As this is a pilot study in humans, we used preclinical data from our porcine 
burn model to inform the choice of sample size. For a full clinical study we estimate a need to enroll 29 patients. 
We acknowledge we may not have a large enough sample size to measure significant improvement.  However, 
the data obtained will aide in the more accurate calculation of the needed sample size for further human studies.  
In addition, the prospective documentation of safety will increase our competitiveness for funding for a full study.  
For this pilot study we propose enrolling only 15 patients – the number at which we would have conducted an 
interim analysis and assess safety if we were to proceed with enrollment of 29 patient s (current estimate for full 
study).  The primary endpoint that we will assess is the scar area at 90 days post-grafting.  We will conduct 
analysis for efficacy after the patients have each reached 90 days post-grafting using the spending function of Lan 
and Demets24. There is not an accepted standard for the measure of graft loss or an expected “percent take”.  Some 
have proposed to use less than or greater than 50% of graft loss reflecting the difficulty25.  In an effort to proceed 
in a conservative fashion, an adverse safety outcome (namely graft loss not evident by physical changes visible 
on Day 7-10 photographs, will be defined as a 5% or greater, laser-associated graft loss with a rate in patients of 
15% or greater deemed unacceptable. In a previous study of burn patients with heterogeneous types of scars, it 
was noted that those treated with FxCO2 were most likely to complain of postoperative pain (8/42 patients, or 
19%), followed by reports of fever (2 out of 42 patients, or 4.8%), development of hypopigmentation (2/42 or 
4.8%), rash (1/42, or 2.4%), or blistering (1/42, or 2.4%)26.  
 
Statistical Plan and Data Analysis 
The primary endpoint of the full trial is the burn scar area at 90 days post-grafting.  For the primary 
analysis, we will compare the log transformed area of the scar for the treatment wounds to the control wounds.  
We will use linear mixed effects models that will adjust for fixed effects of the baseline wound surface area 
grafted (prior to the occurrence of any significant contracture) and treatment center.  A random effect will be 


 
9 
included in the model for each patient to account for dependence between the treatment and control sites.  The 
primary analysis will follow intention to treat principles and will be conducted at the two-sided 0.05 level27,28.   
 
Secondary objective endpoints include scar roughness, biomechanics as measured by stiffness and 
elasticity, redness measured by erythema each, examined at 90 days post-grafting.  Secondary analyses will follow 
the same general framework as outlined for the primary analysis.  Outcome variables may be log transformed to 
satisfy necessary distributional assumptions for the analysis.  Secondary subjective endpoints are the VSS and 
POSAS scores at 90 days post-grafting.  These endpoints will be analyzed within the same framework as described 
for the other primary and secondary endpoints.  In addition, we will examine all endpoints at 1 year post-grafting 
to characterize the effects of treatment on longer term healing. 
 
We will also conduct exploratory longitudinal analyses of the primary and secondary endpoints.  Since 
we will observe each endpoint at multiple visits across time, we will use longitudinal mixed effects models to 
explore the healing profile across time for both the treatment and control group.  
For efficacy, analysis will be interested in assessing the primary endpoint through the error spending 
function approach described by Lan and Demets24,29.  For safety, an adverse safety outcome will be defined as a 
5% or greater, laser-associated graft loss with a rate in patients of 15% or greater deemed unacceptable.  If there 
are 6 adverse safety outcomes within the first 15 patients, we will terminate the study due to an unacceptable 
safety risk to patients.   
Data Collection 
Data will be collected on Case Report Forms (CRF) and individual SD cards (for photographs) kept with 
the CRF for each individual patient.  These CRFs and SD cards will be stored in the locked office of the CRC 
and in a locked file cabinet. 
 
Data and Safety Monitoring Committee 
A Data Safety and Monitoring Committee (DSMC) will be formed and will meet every 6 months 
throughout the period during which patients are being recruited and experiencing follow-up. The DSMC will 
review data provided by the primary study statisticians and other study staff involved in data management and 
analysis. The committee will consist of Martin Avery, MD(a trauma surgeon at WFBMC, Molly J. Thompson, 
PhamD (Specialty Practice Pharmacist – Critical Care at the Ohio State University), and Rachel Penny PA (PA 
at the Ohio State University - experienced with appearance of grafts, laser patient care, and clinical trials.  All 
unexpected non-serious adverse events and serious adverse events relating to participation in the study will be 
reported verbally and in writing to the local IRB and the study PI.. The verbal report will occur within 48 hours 
of the occurrence. The written report of a serious adverse event (e.g., death or life-threatening adverse event) 
will be reported within 7 days. 
 
 
 
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Krakowski AC, Diaz L, Admani S, Uebelhoer NS, Shumaker PR. Healing of chronic wounds with 
adjunctive ablative fractional laser resurfacing in two pediatric patients. Lasers Surg Med. 2015. 
13. 
Stephan FE, Habre MB, Helou JF, Tohme RG, Tomb RR. Fractional CO2 laser treatment for a 
skingraft. J Cosmet Laser Ther. 2015:1-7. 
14. 
Zuccaro J, Ziolkowski N, Fish J. A Systematic Review of the Effectiveness of Laser Therapy for 
Hypertrophic Burn Scars. Clin Plast Surg. 2017;44(4):767-779. 
15. 
Ratner D. Skin grafting. From here to there. Dermatol Clin. 1998;16(1):75-90. 
16. 
Padgett EC. SKIN GRAFTING AND THE "THREE-QUARTER"-THICKNESS SKIN GRAFT FOR 
PREVENTION AND CORRECTION OF CICATRICIAL FORMATION. Ann Surg. 1941;113(6):1034-
1049. 
17. 
Ford TS, Schumacher J, Brumbaugh GW, Honnas CM. Effects of split-thickness and full-thickness 
skin grafts on secondary graft contraction in horses. Am J Vet Res. 1992;53(9):1572-1574. 
18. 
Corps BV. The effect of graft thickness, donor site and graft bed on graft shrinkage in the hooded 
rat. Br J Plast Surg. 1969;22(2):125-133. 
19. 
Gurtner GC, Dauskardt RH, Wong VW, et al. Improving cutaneous scar formation by controlling the 
mechanical environment: large animal and phase I studies. Ann Surg. 2011;254(2):217-225. 
20. 
Januszyk M, Wong VW, Bhatt KA, et al. Mechanical offloading of incisional wounds is associated 
with transcriptional downregulation of inflammatory pathways in a large animal model. 
Organogenesis. 2014;10(2):186-193. 
21. 
Rose MP, Deitch EA. The clinical use of a tubular compression bandage, Tubigrip, for burn-scar 
therapy: a critical analysis. Burns Incl Therm Inj. 1985;12(1):58-64. 
22. 
Brewin MP, Lister TS. Prevention or treatment of hypertrophic burn scarring: a review of when 
and how to treat with the pulsed dye laser. Burns. 2014;40(5):797-804. 
23. 
Bailey JK, Blackstone BN, DeBruler DM, et al. Effects of early combinatorial treatment of 
autologous split-thickness skin grafts in red duroc pig model using pulsed dye laser and fractional 
CO2 laser. Lasers Surg Med. 2017. 
24. 
DeMets DL, Lan KK. Interim analysis: the alpha spending function approach. Stat Med. 1994;13(13-
14):1341-1352; discussion 1353-1346. 
25. 
Nosanov LB, McLawhorn MM, Hassan L, et al. Graft loss: Review of a single burn center's 
experience and proposal of a graft loss grading scale. J Surg Res. 2017;216:185-190. 
26. 
Clayton JL, Edkins R, Cairns BA, Hultman CS. Incidence and management of adverse events after 
the use of laser therapies for the treatment of hypertrophic burn scars. Ann Plast Surg. 
2013;70(5):500-505. 
27. 
Ruiz-Canela M, Martínez-González MA, de Irala-Estévez J. Intention to treat analysis is related to 
methodological quality. BMJ. 2000;320(7240):1007-1008. 
28. 
Lee YJ, Ellenberg JH, Hirtz DG, Nelson KB. Analysis of clinical trials by treatment actually received: 
is it really an option? Stat Med. 1991;10(10):1595-1605. 


 
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29. 
Lan KKG, DeMets DL. Discrete Sequential Boundaries for Clinical Trials. Biometrika. 
1983;70(3):659-663. 
30. 
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture 
(REDCap)--a metadata-driven methodology and workflow process for providing translational 
research informatics support. J Biomed Inform. 2009;42(2):377-381. 
 

ICF_000.pdf: 
Official Title: Pilot Study of Early Postoperative Fractional Ablative Laser 
Treatment of Skin Grafts for Burns
NCT04176705
IRB-Approved Date:  1/9/23


Page 1 of 10
Adult Consent Form
IRB Template Version 2/15/2019
Department General Surgery
PILOT STUDY OF EARLY POSTOPERATIVE FRACTIONAL ABLATIVE LASER 
TREATMENT OF SKIN GRAFTS FOR BURNS
Informed Consent Form to Participate in Research
J. Kevin Bailey, MD, Principal Investigator
SUMMARY
You are invited to participate in a research study. The purpose of this research is to determine the 
effects of early use of fractional ablative laser on skin grafts within 6-10 days of split-thickness 
skin graft surgery.  Fractional ablative laser is currently used on skin grafts after they are more 
mature to assist with improving the overall appearance of the scar and help make it less 
restrictive.  The laser used in this study will allow your doctor to precisely target and effectively 
treat your skin graft scars at the surface, middle and deep layers. The laser uses a small beam of 
light to make a checkerboard pattern on your scar that goes to the bottom layer of your skin. You 
are invited to be in this study because you have a burn that will require skin grafting. Your 
participation in this research will involve approximately 5 visits and last about one year.
Participation in this study will involve post-operative examination and measurement of your 
scars, 3 post-operative laser treatments and post-operative clinic visits, and filling out a survey 
about your scars.  All research studies involve some risks.  A risk to this study that you should be 
aware of is pain, possible fever, lightening of the skin, rash or blistering.  There is the possibility 
that you may 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.  There may be other choices available to you.  Some other choices may include 
not participating in the study.  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 
study. The person in charge of this study is:                                                                 
     J. Kevin Bailey, MD
     
                                                                 
     
If you have questions, suggestions, or concerns regarding this study or you want to withdraw 
from the study his contact information is: 
.
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00058363
Meeting Date Approved 1/9/2023          
Version Valid Until: 1/8/2024


Page 2 of 10
Adult Consent Form
IRB Template Version 2/15/2019
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 Research Subject 
Advocate at Wake Forest at 
.
INTRODUCTION
You are invited to be in a research study. Research studies are designed to gain scientific 
knowledge that may help other people in the future. You are being asked to take part in this 
study because you have a burn that will require grafting. Your participation is voluntary. Please 
take your time in making your decision as to whether or not you wish to participate. 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?
Doctors and patients refer to all areas of skin changes from burn injury as burn scars.  However, 
different areas of scars from burns can be treated differently.  The burn scars that come from skin 
grafting surgery might be improved with laser treatment. The purpose of this study is to see if 
treating your burn skin graft scars with a laser could make it better.  
Fractional Ablative Laser has been approved by the US Food and Drug Administration (FDA), 
but it has not been approved for use in the early stages of scar maturation and is considered 
investigational for this study.
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
This is a study with a total of 15 burn patients participating from our institution.
WHAT IS INVOLVED IN THE STUDY?
If you decide to be a part of this study, you will first sign this Informed Consent. After you have 
agreed and signed this form, we will examine and measure your scars. If there is one single scar, 
it will be divided into two different areas.  If you have two different areas of skin grafts, each 
area will be a site. Sites will be called A and B.  This is a randomized study, which means one 
site (A or B) will be assigned by chance (like flipping a coin) to receive the laser treatment, 
while the other one will be assigned to no laser treatment.  We will trace out each site and then 
select three locations inside each site.  These will be the locations we measure each time you 
come for a study visit, and we will ask you to really focus on these three locations when you 
answer questions about how you think your scars are doing.  Each time you visit, measurements 
will be done before the laser treatment. We understand how valuable your time is, so the three 
laser treatments will be completed at weeks 1(6-10 days after skin grafting), week 5 and 9, and 
measurement sets done at weeks 1, 5, 9, 12 and 24.  Although it sounds like a lot of visits, it is 
typical for us to follow burn patients for at least a year to help them get the best results.
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00058363
Meeting Date Approved 1/9/2023          
Version Valid Until: 1/8/2024


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Adult Consent Form
IRB Template Version 2/15/2019
Before using the laser on your skin graft’s scar, both sites will be covered with a numbing 
medication cream, which will be left on the area for approximately 30 to 45 minutes. We have to 
put it on the non-laser side to make sure the only thing we do different is the laser treatment.  
Because skin grafts are placed over areas of third-degree burn, there are very few nerves – so 
patients have less feeling in these areas of surgery.  The use of numbing cream will also help to 
decrease the discomfort even more.  After the numbing cream has set, the area will be cleaned, 
and the laser treatment will be completed by your surgeon associated with the study.  Each time 
the switch is turned on, the laser shines a very small beam of focused infrared light.  The beam is 
thinner than a common sewing needle and the beam creates a checkerboard of 64 holes on the 
bottom layer of your skin.  You will then have a prescription-strength solution of steroid (similar 
to the hydrocortisone steroid cream used for rashes of the skin) applied to both site A and B.
After the treatment is completed, you will be asked to care for your grafts as your doctors and 
nurses have shown you (so the skin grafts are treated the same). 
In addition to the laser treatment, the other important part of this study is to make very exact 
measurements of your two scar sites. We will take measurements (trace the outline of your burn 
scar) before each of the three laser treatments and then two times after that.  .  Because the skin 
graft is fragile at first, we will only take pictures and trace the outline of your skin graft scars the 
first two times (7-10 days and at about 5 weeks from your skin graft surgery).
 At the next three visits (9 weeks, 12 weeks, and 10-12 months after your skin graft surgery) we 
will ask you to fill out a survey where you tell us about what you think about each of the two 
sites–this is the patient portion of the Patient and Observer Scar Assessment Scale (POSAS).   
We will fill out a survey as well – the observer portion of the POSAS and the Vancouver Scar 
Scale (VSS).  In addition, we will make three additional specialized measurements. The BTC-
2000 is a machine that applies a gentle amount of suction into a tube placed against your skin.  It 
measures how much the skin might move up into the tube (because of the gentle suction).  The 
Mexameter is an instrument that is gently pressed onto your skin and it takes a picture to give a 
number of the amount of redness and brown color in a small area.  Finally, we will take an 
impression of the scar using the same material a dentist might use to take a mold of your teeth.  
We use this to make a model of your scar to measure how high it is.
HOW LONG WILL I BE IN THE STUDY?
You will be receiving active treatment for a total of 12 weeks from the moment you sign 
informed consent, and the final measurement will be about one year after your skin grafting. 
Burn patients typically have frequent visits during their first few months, and usually follow up 
in the burn clinic for a year or more after skin grafting.  We will make the measurements and 
treat with the laser when you are coming to the clinic for your routine care to avoid extra visits.
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 to learn about any potential health or 
safety consequences
WHAT ARE THE RISKS OF THE STUDY?
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00058363
Meeting Date Approved 1/9/2023          
Version Valid Until: 1/8/2024


Page 4 of 10
Adult Consent Form
IRB Template Version 2/15/2019
Being in this study involves some risk to you. You should discuss the risk of being in this with 
the study staff. Risks and side effects related to the procedures we are studying include:
- Pain (similar to a mild sunburn), experienced by 19% of the patients treated with laser 
therapy. We will try to reduce this pain by applying a numbing cream before we start the 
procedure. 
- Subjective fever, experienced by 4.8% of patients. This can be easily treated with over 
the counter ibuprofen or acetaminophen.
- Lightening of dark skin (4.8%), rash (2.4%), and blistering (2.4%). Changes in the skin 
tone and rash are not uncommon side effects on skin grafts even without laser treatment. 
The measurements (BTC-2000, Mexameter, and dental molding materials) are painless.  Because 
we are delaying treatment until the graft is well healed, we do not expect any damage to the skin 
grafts. We know that some burn scars can be more sensitive than others. Although unlikely, there 
may be a chance of discomfort from some of the testing (tapping, twisting and suction on your 
scar), but any discomfort will be minimal and would last less than five minutes.  The discomfort 
will be minimized by making sure that there is time between trials for the skin to return to 
normal before collecting the next measurement. In addition, if the patient feels any discomfort 
during a particular measurement, this measurement can be stopped and not performed again. 
Finally, we will ask you if the area we want to study is especially sensitive. If it is a sensitive 
area, we will try to see if another area can be tested.  Mechanical tests will be performed using a 
BTC-2000™.  The BTC-2000™ sticks a probe onto the skin using double-sided tape and applies 
a slight suction to the area. The skin changes shape in response to the suction and this change is 
used to calculate the properties of the skin. It would feel like a small suction cup being applied to 
the skin, and may result in temporary redness at the site. 
We hope that the skin grafts treated with the laser may not shrink as much.  If this happens, you 
could notice that the areas not being treated with the laser feel “tighter” or do not look as good.  .  
In addition, there is a slight risk of a breach of confidentiality.  We will do our best to protect 
your confidential information.  There also may be other 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.
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.  A Data Safety and Monitoring Committee, an independent group of 
experts, will be reviewing the data from this research throughout the study.
Reproductive Risks and other Issues to Participating in Research
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00058363
Meeting Date Approved 1/9/2023          
Version Valid Until: 1/8/2024


Page 5 of 10
Adult Consent Form
IRB Template Version 2/15/2019
Due to unknown risks and potential harm to the unborn fetus, sexually active women of 
childbearing potential must use a reliable method of birth control while participating in this 
study. Reliable methods of birth control are: abstinence (not having sex), oral contraceptives, 
OrthoEvra patch, NuvaRing, intrauterine devices (IUD), Nexplanon implant, DepoProvera, tubal 
ligation, or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous 
relationship (same partner). An acceptable, although less reliable, method involves the careful 
use of condoms and spermicidal foam or gel and/or a diaphragm with spermicide with Plan B 
used for any noticed condom or diaphragm failures. We encourage you to discuss this issue 
further with your physicians if you have any questions.
Pregnant women are excluded from participation in this study. Before your original surgery (skin 
grafting) you will have been tested for pregnancy.  If you are not using a reliable method of birth 
control (listed in paragraph above), please let the research team know.
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. Potential 
Benefits: 
o With laser treatment, we are hopeful we can demonstrate less contraction (“shrinkage” of 
your skin graft) and an increase in the elasticity of your skin, and have you regain some 
of the mobility you had in the affected area prior to your injury. 
o There is the potential you can avoid the need for future reconstructive surgeries when 
treated with laser. 
WHAT OTHER CHOICES ARE THERE?
You do not have to be in this study to receive treatment. You should talk to your doctor about all 
the choices you have. Instead of being in this study, you have these options:
Proceed with normal healing without the use of Fractional Ablative Laser
 
WHAT ARE THE COSTS?
All study costs, including any study medications and 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.
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.  There is always some risk that even de-identified information might be re-identified. 
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00058363
Meeting Date Approved 1/9/2023          
Version Valid Until: 1/8/2024


Page 6 of 10
Adult Consent Form
IRB Template Version 2/15/2019
Participant 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 be receive a $25 gift card for each of the completed scheduled study visits, for a total of 
$100.00 if first visit is while still in the hospital, $125.00 if first visit is completed in clinic after 
hospital discharge.  If you withdraw for any reason from the study before completion you will 
not receive any further compensation beyond those visits that have been completed at the time of 
withdrawal.  To receive payment, you must provide your social security number, name and 
address so that we can comply with IRS (Internal Revenue Service) reporting requirements. 
When payments are reported to the IRS we do not let them know what the payment is for, only 
that you have been paid.  If you do not wish to provide this information you can still take part in 
this study but you will not be paid.
WHO IS SPONSORING THIS STUDY?
This study is being conducted by Dr. John Kevin Bailey at Wake Forest Baptist Medical Center.   
 
WHAT HAPPENS IF YOU EXPERIENCE AN INJURY OR ILLNESS AS A 
RESULT OF PARTICIPATING IN THIS STUDY?
Should you experience a physical injury or illness as a direct result of your participation in this 
study, Wake Forest University School of Medicine maintains limited research insurance 
coverage for the usual and customary medical fees for reasonable and necessary treatment of 
such injuries or illnesses. 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. Wake Forest University Baptist Medical Center holds the insurance policy for this 
coverage. It provides a maximum of $25,000 coverage for each claim and is limited to a total of 
$250,000 for all claims in any one year. The Wake Forest University School of Medicine, and 
the North Carolina Baptist Hospitals, Incorporated do not assume responsibility to pay for these 
medical services or to provide any other compensation for such injury or illness. Additional 
information may be obtained from the Medical Center’s Director of Risk and Insurance 
Management, at 
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.
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00058363
Meeting Date Approved 1/9/2023          
Version Valid Until: 1/8/2024


Page 7 of 10
Adult Consent Form
IRB Template Version 2/15/2019
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 Dr. J. Kevin Bailey at 
 or 
 after hours.
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: 
Your name, age, medical record number and thickness of burn, burn scar measurements and 
photographs of your burn scars.
If this research study involves the diagnosis or treatment of a medical condition, then Protected 
Health Information collected from you during this study 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. 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 personal health information and information that identifies you (“your health information”) 
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 Wake Forest University Health 
Sciences and North Carolina Baptist Hospital; 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.
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00058363
Meeting Date Approved 1/9/2023          
Version Valid Until: 1/8/2024


Page 8 of 10
Adult Consent Form
IRB Template Version 2/15/2019
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  be de-identified.. You will not be 
able to obtain a copy of your Protected Health Information in the research records until all 
activities in the study are completely finished. 
You can tell Dr. J. Kevin Bailey 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:
    J. Kevin Bailey, 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.
If you choose to participate in this study, your medical record at Wake Forest University Baptist 
Medical Center will indicate that you are enrolled in a clinical trial.  Information about the 
research and any medications or devices you are being given as a participant may also be 
included in your medical record.  This part of the medical record will only be available to people 
who have authorized access to your medical record.  If you are not a patient at this Medical 
Center, a medical record will be created for you anyway to ensure that this important information 
is available to doctors in case of an emergency.
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 Wake Forest 
University Health Sciences and North Carolina Baptist Hospital.  These will be kept secure, with 
access to this information limited to individuals with proper authority, but who may not be 
directly involved with this research study.
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00058363
Meeting Date Approved 1/9/2023          
Version Valid Until: 1/8/2024


Page 9 of 10
Adult Consent Form
IRB Template Version 2/15/2019
A North Carolina Baptist Hospital (NCBH) medical record will be created for all study 
participants. Information about your participation in the study will be placed in the NCBH 
medical record, along with any routine medical test results that were obtained at NCBH as part 
of this study. 
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 of you not following study instructions, intolerance to laser 
treatment or new information becomes available that requires your doctor to withdrawal you 
from the study, or that the study is stopped permanently.  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.
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 
investigator, call Dr. J. Kevin Bailey at 
 or 
 after hours.
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.
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00058363
Meeting Date Approved 1/9/2023          
Version Valid Until: 1/8/2024


Page 10 of 10
Adult Consent Form
IRB Template Version 2/15/2019
Subject Name (Printed):_____________________________
Subject Signature: _________________________________ Date: ________Time:_______ am pm 
Person Obtaining Consent (Printed):_____________________________
Person Obtaining Consent:___________________________ Date:_________ Time:________ am pm
Legally Authorized Representative Name (Print):_________________________
 
The above named Legally Authorized Representative has legal authority to act for the research 
subject based upon (specify health care power of attorney, spouse, parent, etc.)
Relationship to the Subject:_____________________________
Legal Representative Signature: _________________________ Date:_________ Time:________ am pm
WFU School of Medicine 
Institutional Review Board 
IRB Number:IRB00058363
Meeting Date Approved 1/9/2023          
Version Valid Until: 1/8/2024