The Use of Integra in Coverage of Radial Forearm Free Flap Donor Site Defect
Phase: NA
Conditions: Head and Neck Cancer
Sponsor: Wake Forest University Health Sciences

The Use of Integra© in Coverage of Radial Forearm Free Flap Donor Site Defect 
Comprehensive Cancer Center of Wake Forest University (CCCWFU) 
CCCWFU # 99915A 
 
Protocol Version 6: 10.30.17 
Page 1 of 15 
 
Principal Investigator: 
 
Joseph A. Molnar, MD, PhD 
 
 
 
 
 
Plastic and Reconstructive Surgery 
 
 
 
 
 
Wake Forest School of Medicine 
 
 
 
 
 
Winston-Salem, NC 27157 
 
 
 
 
 
336-716-4171 
 
 
 
 
 
jmolnar@wakehealth.edu 
 
 
Co-Investigator(s):  
 
Ryan Rebowe, MD 
 
 
 
 
 
Plastic and Reconstructive Surgery 
 
 
 
 
 
Wake Forest School of Medicine 
 
 
 
 
 
rrebowe@wakehealth.edu 
 
Josh Waltonen, MD 
Department of Otolaryngology 
 
 
 
 
 
Wake Forest School of Medicine 
jwaltone@wakehealth.edu  
 
T. Alex McKnight MD 
Department of Otolaryngology 
Wake Forest School of Medicine 
tmcknigh@wakehealth.edu 
 
Ivo Pestana, MD 
Plastic and Reconstructive Surgery 
Wake Forest School of Medicine 
ipestana@wakehealth.edu 
 
Ellen Stolle Satteson, MD 
Plastic and Reconstructive Surgery 
Wake Forest School of Medicine 
estolle@wakehealth.edu 
 
 
 
Biostatistician: 
Nora Fitzgerald, MS 
 
Department of Biostatistical Sciences 
 
Division of Public Health Sciences 
 
336-716-1469 
 
nfitzger@wakehealth.edu 
 
 
Study Coordinator:  
 
Cecilia Rambarat 
 
 
 
 
 
Plastic and Reconstructive Surgery 
 
 
 
 
 
Wake Forest School of Medicine 
 
 
 
 
 
cgrambar@wakehealth.edu 
 
 
Regulatory Contact:  
 
TBD 
 
 
Participating Institution(s):  
Wake Forest Baptist Medical Center 
 
 

The Use of Integra© in Coverage of Radial Forearm Free Flap Donor Site Defect 
Comprehensive Cancer Center of Wake Forest University (CCCWFU) 
CCCWFU # 99915A 
 
Protocol Version 6: 10.30.17 
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Version Date: 
 
 
11.10.2017 
Amended: 
 
 
 
 
 

The Use of Integra© in Coverage of Radial Forearm Free Flap Donor Site Defect 
Comprehensive Cancer Center of Wake Forest University (CCCWFU) 
CCCWFU # 99915A 
 
Protocol Version 6: 10.30.17 
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Confidential 
 
 
Table of Contents 
1.0 
Introduction and Background .......................................................................................... 4 
2.0 
Objectives ...................................................................................................................... 4 
2.1 
Primary Objective(s) ................................................................................................... 4 
3.0 
Subject Selection ............................................................................................................ 4 
3.1 
Inclusion Criteria ......................................................................................................... 4 
3.2 
Exclusion Criteria ........................................................................................................ 4 
3.3 
Inclusion of Women and Minorities ............................................................................. 5 
4.0 
Registration Procedures ................................................................................................. 5 
5.0 
Study Outcomes and Study Measures............................................................................ 5 
6.0 
Data Management .......................................................................................................... 6 
13.0 
Statistical Considerations ............................................................................................... 7 
References ...............................................................................................................................11 
Appendix A – Reduced Review Registration Form ...................... Error! Bookmark not defined. 
Appendix B – Race Verification Form ........................................................................................15 
 
 
 
 
 
 
 
 
 
 
 
 

The Use of Integra© in Coverage of Radial Forearm Free Flap Donor Site Defect 
Comprehensive Cancer Center of Wake Forest University (CCCWFU) 
CCCWFU # 99915A 
 
Protocol Version 6: 10.30.17 
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1.0 
Introduction and Background 
The radial forearm fasciocutaneous free flap (hereafter referred to as RFFF) was described 
more than 30 years ago as a fasciocutaneous flap for microsurgical transfer.[1] It was soon after 
established as a safe and reliable flap for transfer of fascia and cutaneous tissue.[2, 3] 
Currently, it is used to repair any defect in which a relatively thin island of skin is needed with a 
fascial strength layer .[4-6] While the flap itself is very reliable, it leaves a donor site that can be 
very unsightly and has multiple known complications including loss of pronation, pain, 
paresthesias, cold intolerance, and skin graft necrosis.[7-9] The donor site is typically covered 
with a split thickness skin graft (hereafter referred to as STSG). In an effort to minimize these 
complications, several groups have described a technique of placing Integra© dermal substitute 
(hereafter referred to as Integra) underneath the STSG to provide a thicker support and 
decrease overall morbidity associated with the defect. These studies have shown success in 
decreasing overall morbidity including increasing range of motion and improving aesthetic 
quality of the donor site. However, the largest study to date has included only 29 subjects. 
Furthermore, these studies do not provide a comparative cohort of subjects repaired with a 
classic STSG to show effectiveness of this technique when compared to a classic repair.[10-14] 
Our goal is to perform a prospective study comparing subjects repaired with a classic STSG and 
those repaired with one step Integra and STSG applied at the same time. These subjects will be 
evaluated for overall donor site aesthetic quality and functional outcome as described below. 
1.1 
Primary Objective(s) 
 
Compare donor site aesthetic quality and functional outcomes of subjects with a classic STSG 
and those repaired with Integra and STSG. 
2.0 
Subject Selection 
 
This clinical trial can fulfill its objective only if subjects appropriate for this trial are enrolled.  
2.1 
Inclusion Criteria  
 
2.1.1 All subjects who receive a radial forearm free flaps in the included time period, 
including subjects with head and neck cancer, traumatic defects, chronic 
wounds, or any other problems that require a radical forearm free flap for 
reconstruction. 
 
2.1.2 Have had a distal, anterograde fasciocutaneous flap   
 
  
2.1.3 Age ≥ 18 years   
 
2.1.4 All smokers and tobacco users will be included in this study. 
2.2 
Exclusion Criteria  
 
2.2.1 Subjects who have had an osteocutaneous or musculocutaneous flap. 

The Use of Integra© in Coverage of Radial Forearm Free Flap Donor Site Defect 
Comprehensive Cancer Center of Wake Forest University (CCCWFU) 
CCCWFU # 99915A 
 
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2.2.2 Subjects who have a radial forearm flap with a proximal skin flap or subjects that 
receive a “reverse” radial forearm flap 
2.2.3 Pregnant women will be excluded due to the lack of clinical studies evaluating 
INTEGRA template in pregnant women. 
 
2.3 
Inclusion of Women and Minorities 
 
Men and women of all races and ethnicities who meet the above-described eligibility 
criteria are eligible to participate in this study.  
4.0 
Registration Procedures 
 
All subjects entered on any CCCWFU trial, whether treatment, companion, or cancer control trial, must 
be registered with the CCCWFU Protocol Registrar or entered into ORIS Screening Log. Subjects must 
be registered prior to the initiation of treatment.   
 
You must perform the following steps in order to ensure prompt registration of your subject: 
 
1. Complete the Reduced Review Registration Form (Appendix A) 
2. Complete the Race Verification Form (Appendix B) 
3. Send the Reduced Review Protocol Registration Form, and the Race Verification Form to 
the registrar, either by fax or e-mail. 
 
Contact Information: 
Protocol Registrar PHONE (336) 713-6767 
Protocol Registrar FAX (336) 713-6772 
Protocol Registrar E-MAIL (registra@wakehealth.edu) 
            
*Protocol Registration is open from 8:30 AM - 4:00 PM, Monday-Friday. 
 
 
To complete the registration process, the Registrar will:   
 
 
assign a subject study number 
 
randomize the subject 
 
register the subject on the study 
5.0 
Study Outcomes and Study Measures 
 
For this study, we will include all subjects that meet the above criteria that are receiving 
distal, anterograde fasciocutaneous Radial Forearm Free Flaps. For inclusion in the study, 
only those receiving proximally based flaps with the skin paddle located over the tendons 
will be included. 
 
Informed consent will be take place in the clinic in a private exam room. After reviewing the 
consent form and all questions and concerns have been addressed, if the subject or legally 

The Use of Integra© in Coverage of Radial Forearm Free Flap Donor Site Defect 
Comprehensive Cancer Center of Wake Forest University (CCCWFU) 
CCCWFU # 99915A 
 
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authorized representative chooses to participate, then a signature will be obtained on the 
informed consent document.  
 
Subjects will be randomized to either receive both Integra and a STSG or a regular STSG. 
Consideration of treatment of the donor site will be the same regardless of the final 
destination of transferred tissue.  
 
The subjects will receive the assigned reconstruction as dictated by the protocol. They will 
either receive 1) a 0.012mm STSG or 2) A sheet of Integra directly on the wound bed with 
subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm 
STSG. The skin grafts will be meshed 1:1 for minimal graft distortion and to avoid variability 
of “pie crusting.” The RFFF donor site will then be covered by a non-adherent dressing, 
such as Adaptec, and a vacuum assisted closure (VAC) device. The VAC will stay in place 
for 5 days following surgery, and during this time a simple removable thumb spica splint will 
be placed to prevent wrist motion. Subjects with free tissue transfer will typically have a 4-5 
day hospital admission. The plastic surgery team will follow them during their admission and 
will schedule appropriate follow up at both one and two weeks following surgery. Follow up 
appointments following this time will be at the discretion of the attending physician. 
Scheduled post-operative assessments following the initial assessment will include a 3 
month, 6 month, and one year follow up appointment. Evaluation at the 3-month and 6-
month follow-up appointment,will include photos of the surgical site, evaluation of the skin 
graft and any areas of necrosis or tendon exposure, survey of presence of pain and 
paresthesia, and the QuickDASH survey. During the 1 year follow-up, in addition the 
assessments described above, the Vancouver Scale Assessment will be performed by a Co-
Investigator who is blinded  Areas of tendon exposure will be treated with xeroform dressing 
changes. 
 
During surgery and at the scheduled follow up all subjects will have standardized 
photographs taken utilizing a custom backdrop and a centimeter scale. These pictures will 
be used to assess wound size and dimension at each encounter, including the original 
surgery. This will allow us to measure the rate of wound healing, contracture, and rate of 
skin graft necrosis. The pictures will be analyzed with the SigmaScan planimetry program. 
This protocol has been previously validated and published.[15]  
 
Subjects will be evaluated by the occupational therapy team prior to their surgery in the pre-
operative holding area and during their admission to the hospital. They will be assessed 
using standard measurement from a goniometer and dynamometer and also given 
instructions for wrist range of motion exercises. During follow up, subjects will be referred to 
occupational and physical therapy at the discretion of the attending physician. 
 
Subjects removed from study for unacceptable adverse events will be followed until 
resolution or stabilization of the adverse event. 
 
6.0 
Data Management 
 
Race Verification Form 
ORIS 
Protocol registration form 
ORIS 
Survey Data Capture 
REDCap 
PHI Data Capture 
REDCap 

The Use of Integra© in Coverage of Radial Forearm Free Flap Donor Site Defect 
Comprehensive Cancer Center of Wake Forest University (CCCWFU) 
CCCWFU # 99915A 
 
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13.0 
Statistical Considerations 
 
Endpoints:  
1. Rate of tendon exposure. Previously reported from 12-55%.[7, 16-19]  
2. Rate and percent of skin graft necrosis. Rate previously reported to be from 7%-51%.[7, 9, 16, 20-22] 
Percentage of skin graft loss ranges from ≤5%- ≥20%.[9, 16] 
3. Rate of paresthesia. Previously reported to be 36%- 50%. [9, 20] 
4. Aesthetic outcome of donor site on Vancouver Scar Scale, a validated objective assessment of scar 
appearance.[23] Previous scores are reported to be 4.7/13 without Integra and 4.2/13 with Integra.[14, 24] 
In particular, we will be focusing on the pliability aspect of the Vancouver Scar Scale, which will be a 
measure of the functionality of the skin overlying the donor site. The scores will be taken at the 3,6, and 
12 month follow up.  
5. The Disabilities of the Arm, Shoulder and Hand (DASH) outcome measure is a 30 question survey used to 
quantify the symptoms and function of any person with musculoskeletal disorders of the upper limb. It is 
used to determine the impact that a particular disorder has on an individual’s life.[25, 26] The 
QuickDASH is a shortened version of the DASH that has been validated to be as significant as the full 
questionnaire.[27] While the QuickDash scores of RFFF subjects have not been reported, previous DASH 
scores have been reported to be 6.93 ± 5.54 in RFFF subjects compared to 2.95 ± 4.42 in non-RFFF 
subjects.[28] 
6. Differences in range of motion at the hand, previously reported to be 22-27 degrees difference [8] 
7. Differences in grip and pinch strength in the donor site hand, previously reported to be about a 7kg 
difference in pinch strength and a 0.75kg difference in grip strength. [29] 
8. Wound contracture and Skin Pliability. Normal results are reported below. 
 
Statistical Analysis: 
We plan to enroll 50 subjects in each group.  All hypothesis testing will two sided and performed at the 0.05 
significance level.  All analysis will be performed in SAS Version 9.4 (Cary, NC).  No interim monitoring is 
planned for this study.  
 
 
The analysis and estimated power for each endpoint is described below.  
1. Rate of tendon exposure 
a. We expect about a 25% rate of tendon exposure in the group that does not use Integra, while in 
the Integra group we hope to have a rate of tendon exposure of below 5%. We will test this 
hypothesis using a chi-squared test of equal proportions. We will have 81% power to detect this 
difference with 50 subjects in each group.  
2. Rate and percent of skin graft necrosis 
a. We expect about a 20% rate of skin graft necrosis in the STSG group and about a less than 5% 
rate of skin graft necrosis in the Integra group. To test for a significant difference in the STSG 
and STSG with Integra groups, we will employ a chi-squared test of equal proportions. We will 
have 62% power to detect the difference between the two groups.  

The Use of Integra© in Coverage of Radial Forearm Free Flap Donor Site Defect 
Comprehensive Cancer Center of Wake Forest University (CCCWFU) 
CCCWFU # 99915A 
 
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b. In the STSG group, we expect about 10% of the graft to become necrotic, while we believe that 
below 5% of the STSG with Integra group to become necrotic. We will have approximately 16% 
power to detect this difference using a chi-squared test.   
c. While the study may be underpowered to make this particular observation statistically significant, 
this parameter is not a primary objective of the study but will be easy to measure. 
3. Presence of pain and paresthesia and severity on a 1-10 scale 
a. In the split thickness skin graft group, we expect about 20% of the subjects to still have pain at 
the radial forearm site, while about 35% of these subjects will have significant paresthesias.  In 
the Integra group, we expect about 10% of the subjects to have pain at the radial forearm site, 
while about 20% of these subjects will likely have paresthesias. To tests for significant difference 
in the two groups, we will again employ a chi-sqaured test. We will have 29% power to detect a 
significant difference in pain at the radial forearm site and 39% power to detect a significant 
difference in the rates of paresthesias.  
b. Of the subjects that have pain we expect those who have had Integra© placed to have pain at a 
level of an average of about 3, while those who have not had Integra© will have pain at an 
average level of 7. After evaluating the distribution of the scaled scores, we will test if these 
means are equal using a t-test if data appear normal and a Wilcoxon Rank sum  test if not. 
Assuming the two groups share a common standard deviation of 3, we will have over 99% power 
to detect this difference using a t-test. If data appears non-normal, assuming the probability that 
an observation in the Integra© group has lower severity of pain is 0.75, we will have 99% power 
to detect this difference.  
4. Aesthetic outcome of donor site on Vancouver Scar Scale 
a. The Vancouver Scar Scale encompasses 4 separate outcomes to be objectively assessed. Each has 
been separately reported in the literature for each group in different papers as previously 
mentioned. We will compare the final score as well as scores within each outcome. 
i. Vascularity (0-3): STSG group will likely average a 1, while Integra group will likely 
average around 0 
ii. Pigmentation (0-2): STSG group will likely average a 1 while Integra group will likely 
average a 2 
iii. Height (0-3): STSG group will be an average of about 1, while the Integra group will 
likely average a 0 
iv. Pliability(1-5): We expect the STSG group to average about a 2, while the Integra group 
will average about a 1 
v. Based on these scores, we would expect the STSG group to have a score of 5 while the 
Integra group will have an average score of about 3 
 
We will compare these measures between the two groups using t-tests or Wilcoxon rank sum tests as 
appropriate. Assuming a standard deviation within each group of one and that data appears normal, we 
will have over 99% power to detect a difference of one and two scoring units for these tests.   
  
5. Functional outcome as measured by pre and post-operative assessment on the QuickDASH (Disabilities 
of the Arm, Shoulder, and Hand) scale 

The Use of Integra© in Coverage of Radial Forearm Free Flap Donor Site Defect 
Comprehensive Cancer Center of Wake Forest University (CCCWFU) 
CCCWFU # 99915A 
 
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a. The survey asks the subject to rate the ease of 11 daily activities from 1-5, 1 being no difficulty, 
and 5 being unable to perform. 
i. The scores are then averaged (Giving a score between 1 and 5), and one is subtracted 
from the average. This number is then multiplied by 25  
1. As the lowest possible rating on each activity is 1, this accomplishes bringing the 
lowest possible score to 0.  
2. As the highest possible rating on each activity is 5, this bring the highest possible 
score to be 100 
ii. We will expect similar values as previously cited in the literature. About 70 for the 
subjects receiving a STSG, and values closer to 30 for the Integra group 
iii. We will compare these two groups using t tests or Wilcoxon Rank Sum tests as 
appropriate. Assuming a standard deviation of 10 and that the data appears normal, we 
will have over 99% power to detect this difference using a two sample t test.   
6. Functional outcome as measured by hand strength and Range of Motion 
a. Range of motion will be measured by resident physicians taking part in the project who will be 
trained by the occupational therapy team at our institution. The measurements will be taken using 
electric goniometers so as to standardize the measurements as much as possible. 
i. Previously reported differences in pre and postoperative range of motion of wrist flexion 
and extension have ranged from non-statistically significant to about 27 degrees and 22 
degrees, respectively.1 
1. We will expect the difference in wrist flexion and extension in the non-Integra 
group to be 25 degrees and 20 degrees, respectively. 
2. We will expect the difference in flexion and extension in the Integra group to be 
15 and 10 degrees, respectively.[8] 
3. We will again employ two sample t-tests (or Wilcoxon Rank Sum Tests)  to test 
for differences in these angle measurements. Assuming a common 
standard deviation of five degrees, we will have 99% power to detect a difference 
in five degrees using a two sample t test. 
b. Hand strength will be measured by pinch and grip strength dynamometers obtained from the 
occupational therapy department at our institution. These measurements will be taken at 3 month, 
6 month, and 1 year follow up clinic visits. 
i. Grip strength has been reported to be about a 7kg difference between pre-operative and 
post-operative measurements, while Pinch strength has been shown to differ by 
approximately 0.75kg. [29] 
ii. For the non-integra group, we predict a difference in grip strength of approximately 5kg, 
while the pinch strength will differ but about 0.75kg 
iii. For the Integra group, we predict that the difference in grip strength will be 
approximately 3kg while the pinch strength will differ by approximately 0.25kg. 
iv. At each time point, we will compare the hand strengths of the Integra and non-Integra 
groups using two sample t-tests or Wilcoxon Rank Sum Tests as appropriate. Assuming a 
5kg grip strength standard deviation in each group, we will have over 99% power to 
detect differences of 5kg and 7 kg in each group.  

The Use of Integra© in Coverage of Radial Forearm Free Flap Donor Site Defect 
Comprehensive Cancer Center of Wake Forest University (CCCWFU) 
CCCWFU # 99915A 
 
Protocol Version 6: 10.30.17 
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v. For pinch strength, we assume both groups have a standard deviation of 1kg. To detect a 
difference 0.75kg, we will have 95% power using a two sample t-test. 
7. Wound Contracture and Skin Pliability 
a. We will use the same planimetry software to determine the percent of wound contracture.  
i. Utilizing a dermal substitute, wound contracture has been shown to be as low as 15% of 
total area. We will expect the same amount from our study. [30] 
ii. Wound contracture utilizing standard STSG has been shown in animal models to cause 
wound contracture of up to 38-41%. We will expect wound contracture of about 30% 
from our study. [31,32] 
b. Skin Pliability 
i. We plan to use a Cutometer MPA 580 for measurements of skin pliability. We currently 
have this device on our budget for next year awaiting approval and are separately 
applying for a Plastic Surgery Foundation grant to fund these measurements. 
ii. We plan to measure Pliability (Ua), Elasticity (Ue), Retraction (Ur). Viscoelasticity (Uv), 
and Extension (Uf) 
1. Previously measured values for these parameters in reconstruction utilizing 
Integra are as follows. [33] 
a. Ua= 0.083 (0.192 Control)  
b. Ue=0.088 (0.153 Control) 
c. Ur= 0.037 (0.086 Control) 
d. Uv=0.039 (0.068 Control) 
e. Uf= 0.098 (0.221 Control) 
f. Ur/Uf (Gross Elasticity)=0.377 
g. Ur/Ue (Elastic Function)=0.125 
h. Ua/Uf (Biological Elasticity)=0.846 
2. Previously measured values for these parameters in STSG are reported as ratios 
and are listed here. [34]  
a. Ur/Uf (Gross Elasticity)=0.553 
b. Ur/Ue (Elastic Function) =0.818 
c. Ua/Uf (Biological Elasticity)=0.881 
3. For our study, we will expect the following parameters 
a. Integra+STSG 
i. Ur/Uf=0.4 
ii. Ur/Ue=0.1 
iii. Ua/Uf=0.8 
b. STSG 
i. Ur/Uf=0.6 
ii. Ur/Ue=0.8 
iii. Ua/Uf=0.9 
 
 
 
iii. Should we not obtain funding for a cutometer, we will obtain measurements of maximal 
skin distension over the grafted area and compare it in a ratio to the maximal skin 
distension over the same area in the opposite arm. 

The Use of Integra© in Coverage of Radial Forearm Free Flap Donor Site Defect 
Comprehensive Cancer Center of Wake Forest University (CCCWFU) 
CCCWFU # 99915A 
 
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1. In this manner, we would expect the Integra and STSG to give a ratio of about 
0.75, while the STSG would give a ratio of about 0.4 
 
 
References 
 
1. Yang, G.F., et al., Forearm free skin flap transplantation: a report of 56 cases. 1981. Br J Plast 
Surg, 1997. 50(3): p. 162-5. 
 
2. Soutar, D.S. and I.A. McGregor, The radial forearm flap in intraoral reconstruction: the 
experience of 60 consecutive cases. Plast Reconstr Surg, 1986. 78(1): p. 1-8. 
 
3. Soutar, D.S., et al., The radial forearm flap: a versatile method for intra-oral reconstruction. Br J 
Plast Surg, 1983. 36(1): p. 1-8. 
 
4. Khan, M.A., et al., Free radial forearm fasciocutaneous flap in the treatment of distal third tibial 
osteomyelitis. Ann Plast Surg, 2012. 68(1): p. 58-61. 
 
5. Medard de Chardon, V., et al., The radial forearm free flap: a review of microsurgical options. J 
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8. Skoner, J.M., et al., Short-term functional donor site morbidity after radial forearm 
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suprafascial dissection of the radial forearm flap. Microsurgery, 2007. 27(7): p. 583-7. 
 
11.  Murray, R.C., et al., Reconstruction of the radial forearm free flap donor site using integra 
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13. Senchenkov, A., Reconstruction of radial forearm donor-site defects with Integra and staged 
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Comprehensive Cancer Center of Wake Forest University (CCCWFU) 
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20. Karimi, A., P. Mahy, and H. Reychler, Closure of radial forearm free flap donor site defect with a 
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study. J Int Med Res, 2014. 42(1): p. 231-5. 
 

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29. Brown, M.T., M.E. Couch, and D.M. Huchton, Assessment of donor-site functional morbidity 
from radial forearm fasciocutaneous free flap harvest. Arch Otolaryngol Head Neck Surg, 1999. 
125(12): p. 1371-4. 
 
30. Hur, G.Y., D.K. Seo, and J.W. Lee, Contracture of skin graft in human burns: Effect of   artificial 
dermis. Burns, 2014. 
 
31. Brown, D.M., et al., Decreased wound contraction with fibrin glue--treated skin grafts. Arch 
Surg, 1992. 127(4): p. 404-6. 
 
32. Rudolph, R., The effect of skin graft preparation on wound contraction. Surg Gynecol Obstet, 
1976. 142(1): p. 49-56. 
 
33. Moiemen, N., et al., Long-term clinical and histological analysis of Integra dermal regeneration 
template. Plast Reconstr Surg, 2011. 127(3): p. 1149-54. 
 
34. Nguyen, D.Q., T.S. Potokar, and P. Price, An objective long-term evaluation of Integra (a dermal 
skin substitute) and split thickness skin grafts, in acute burns and reconstructive surgery. Burns, 
2010. 36(1): p. 23-8. 
 
 
 
 

The Use of Integra© in Coverage of Radial Forearm Free Flap Donor Site Defect 
Comprehensive Cancer Center of Wake Forest University (CCCWFU) 
CCCWFU # 99915A 
 
Protocol Version 6: 10.30.17 
Page 14 of 15 
 
APPENDIX A: REDUCED REVIEW** REGISTRATION FORM 
 
Protocol#: 99915A 
 
 
 
 
 
 
*Required Field  
 
Protocol Title: The Use of Integra® in Coverage of Radial Forearm Free Flap Donor Site Defect 
 
CCCWFU#99915A 
 
DEMOGRAPHICS 
 
Name (last, first) : ________________________, ________________________________ 
(or initials)  
 
UNIT # (MRN): _________________ (required if exists) 
Zip Code:__________ (required if no MRN) 
 
*SEX ﴾  ﴿ MALE 
(   ﴿ FEMALE  
 
*ETHNICITY (choose one): (   ﴿ HISPANIC ﴾   ﴿ NON-HISPANIC 
  
 
 
 
 
 
 
 
  
 
 
 
-AMERICAN 
 
 
  
 
 
 
 
 
 
 
*DIAGNOSIS : ____________________________________________________ 
 
 
BIRTH DATE: _______________________________(include if no MRN is provided) 
 
*MD Name (last, first): _________________________________   
 
 
*DATE CONSENT WAS SIGNED: __________________ 
 
Date of Registration (if different): __________________________ 
 
PID#: ______________________ (to be completed by Registrar) 
 
 
The Comprehensive Cancer Center requires that all registrations be sent to the CCCWFU Centralized Registrar 
the day the patient is consented; if this is not possible we require that all registrations be communicated to the 
Centralized Registrar within 72 hours of consent. 
**Reduced review means eligibility and other review are not performed by CRM registrar. Questions: call 713-
6767 
 
 
Submit by Email*** 
Print Form 
 
*** If not using the full wfubmc edu outlook client (full outlook, not web outlook), save this file and attach 
to an email to regjstra@wfubmc .edu  
Submitter  of this form is responsible for insuring that all regulatory and eligibility requirements are met 
for this registration.

The Use of Integra© in Coverage of Radial Forearm Free Flap Donor Site Defect 
Comprehensive Cancer Center of Wake Forest University (CCCWFU) 
CCCWFU # 99915A 
 
Protocol Version 6: 10.30.17 
Page 15 of 15 
 
 Appendix B – Race Verification Form 
 
Thank you so much for helping us to verify your race and ethnicity to ensure the quality of our 
information. As a brief reminder, the information you provide today will be kept confidential. 
1. Are you: 
Hispanic or Latino/a   
Not Hispanic or Latino/a 
2. What is your race? One or more categories may be selected. 
White or Caucasian 
Black or African American American Indian or 
Alaskan Native Asian 
Native Hawaiian or Other Pacific Islander 
Other, Please Specify: _______________________________________ 
 
                                                            
Internal use only: 
Was the self-reported race and ethnicity of the participant verified at the time of consent? 
Yes       No 
 
Was a discrepancy found?       Yes        No 
If yes, please provide what is currently indicated in the EMR: 
 
Ethnicity: _____________________________   Race: _________________________________                                              
 
Additional comments:  ______________________________________________________________ 
___________________________________________________________________________________ 
___________________________________________________________________________________