Surgical Drape With an Atraumatic Acrylic Adhesive for Negative Pressure Wound Therapy
Phase: NA
Conditions: Frequency and Type of Medical Adhesive-Related Skin Injury, NPWT Drape Seal Effectiveness Rate (or Leak Incidence Rate), Clinician Acceptability of New NPWT Drape, Patient Drop-out Rate From Prescribed NPWT Treatment, Pain Assessment During Medical Adhesive Drape Removal
Sponsor: Global Biomedical Technologies, LLC

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                    PROTOCOL STUDY 
 
                1 R44 NR021251-01 
Title: Surgical drape with a releasable acrylic adhesive for atraumatic negative pressure wound 
therapy. 
 
 
 
 
 
 
                            Howard S Rosing, MD, PhD Sponsor & Principle-Investigator 
                                                  Global Biomedical Technologies, LLC 
 
 
 
 
                                                       Version: 2.3 October 13, 2025 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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1. NAME AND ADDRESSES OF INVESTIGATORS.............................................................3- 4  
2. INVESTIGATIONAL AGENT.......................................................................................... 5  
3. REPORT OF PRIOR INVESTIGATIONS ......................................................................5-8 
4. INVESTIGATIONAL PLAN ............................................................................................. 8  
    4.1 PURPOSE………………………………………………………..…..…….……..….8-9 
          4.1.1 PRIMARY EFFECTIVENESS ENDPOINT....................................................9-10  
           4.1.2. SAFETY ENDPOINTS ..................................................................................... 11 
          4.1.3 SECONDARY EFFECTIVENESS ENDPOINT…………….…………………11  
    4.2 PROTOCOL……..………………………………...……………..………..………11-22  
          4.2.1 OVERVIEW ..................................................................................................23-26  
          4.2.2 SAMPLE SIZE DETERMINATION..............................................................27-28 
          4.2.3 ENROLLMENT….............................................................................................. 29  
          4.2.4 STUDY DURATION...........................................................................................29  
          4.2.5 INCLUSION CRITERIA.................................................................................30-31  
          4.2.6 EXCLUSION CRITERIA.................................................................................... 31  
          4.2.7 PRIOR AND CONCOMITANT THERAPY...................................................... 31  
          4.2.8 TREATMENT REGIMEN..............................................................................31-32  
          4.2.9 POSTOPERATIVE REGIMEN .......................................................................... 32  
          4.2.10 CASE REPORT FORMS..............................................................................32-33 
    4.3 RISK ANALYSIS.....................................................................................................33-34  
    4.4 DESCRIPTION OF DEVICE....................................................................................... 34  
    4.5 MONITORING PLAN.................................................................................................. 34  
          4.5.1 PRIMARY SAFETY ENDPOINTS.......................................................................35  
          4.5.2 DEFINITIONS................................................................................................ 35-36  
          4.5.3 RECORDING OF ADVERSE EVENTS .............................................................. 36  
          4.5.4 REPORTING OF SERIOUS ADVERSE EVENTS ............................................. 36  
          4.5.5 UNBLINDING PROCEDURES .......................................................................... 37  
          4.5.6 STOPPING RULES.............................................................................................. 37  
          4.5.7 Internal Data and Safety Monitoring Board........................................................... 37  
          4.5.8 Independent Data and Safety Monitoring Board ................................................... 37 
5. MANUFACTURING INFORMATION.............................................................................38  
6 INVESTIGATOR AGREEMENT ......................................................................................38  
7 INVESTIGATOR CERTIFICATION................................................................................ 38  
8. IRB’s INFORMATION..................................................................................................... 38  
9. NAME AND ADDRESS OF THE INVESTIGATIONAL INSTITUTION..................... 39  
10.  FINANCIAL CLAIMS.........................................................................................................39  
    10.1 FUNDING SOURCE................................................................................................ 39  
    10.2 CONFLICT OF INTEREST...................................................................................... 39  
    10.3 SUBJECT STIPENDS OR PAYMENTS.................................................................. 39  
11. ENVIRONMENTAL ASSESSMENT......................................................................... 39  
12. REFERENCES...........................................................................................................40-41 
13. ATTACHMENTS ............................................................................................................42 
 
 
 
 
 

 
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1. NAME AND ADDRESSES OF INVESTIGATORS  
A. Sponsor & Principal Investigator 
Howard S. Rosing, MD, PhD 
CEO, Global Biomedical Technologies, LLC  
6350 Lake Oconee Pkwy, Ste 110, PMB 11 Greensboro, GA 30642 
Contact: hrosing@comfortrelease.com  
Phone: (m) 239-330-5646 
(o) 833-726-9269 Ext 710 
  
B. Principal Investigator 
 
Robert John Winchell, MD 
Chief, Division of Trauma & Burns Weill Cornell Medical Center 
525 East 68th Street, Room P7-714, 
Box 116 New York, NY 10065 
Contact: row9057@med.cornell.edu Phone: 646-962-8490 
 
C. Co-Principal Investigator Jarrod Terrence Bogue, MD 
Clinical Instructor in Surgery, Columbia 
University 161 Fort Washington Avenues, Suite 5 
New York, NY 10032 
Contact: jb3892@cumc.columbia.edu 
Phone: 203-668-8595 
 
D. Co-Principal Investigator 
Daniel Careaga, M.D. 
Contact: drcareaga@absolutemedicalcenter.com 
Phone: 305-508-0004 
Absolute Medical Center 
5040 Northwest 7th Street, Suite 500 
Miami, Florida 33126 
www.absolutemedicalcenter.com 

 
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Careaga Plastic Surgery 
        220 Alhambra Circle, First Floor 
 Coral Gables, FL 33134 
 
E. Co-Principal Investigator 
Deeva Frankel, DPM, D.ABFAS 
Contact: Frankel.d@vitalmedicalresearch.com 
Vital Medical Research, LLC 
10780 W Flagler ST, Suite #6, 
Sweetwater, FL 33174 
Phone: (305) 703-4414 
https://vitalmedicalresearch.com 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
           

 
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2. INVESTIGATIONAL AGENT 
 
Global Biomedical Technologies, LLC(“GBT”) has developed a 
method to blend a proprietary resin “OGS” (oligo- glycerol sebacate) 
with an pressure sensitive acrylic adhesive and coat onto surgical 
drapes. This is the Comfort Release® innovation: a strong bonding, 
switchable atraumatic adhesive. This new adhesive Negative 
Pressure Wound Therapy (NPWT) drape, when properly triggered, 
releases painlessly and trauma free from the skin. This innovative 
NPWT drape is important to decrease the typical pain and 
discomfort associated with common wound vacuum (V.A.C.®) 
therapy drape removal and is expected to increase patient 
compliance for the prescribed duration of NPWT treatment. This is 
especially important for patients with frail, geriatric, or sensitive 
skin, as well as those patients enduring multiple wound vac 
applications with strong, skin irritating adhesive NPWT drapes. 
 
3. REPORT OF PRIOR INVESTIGATIONS 
Global Biomedical Technologies, LLC has not conducted prior 
clinical IRB supported studies on the new Comfort Release® Drape. 
The Comfort Release® Drape has undergone preliminary clinical 
and non-clinical studies to support its safety features. These studies 
include an analysis of the adhesive skin binding using standard peel 
strength testing and moisture vapor transmission rate to measure 
breathability in direct comparison to the Control Drape being used in 
this study (Data is available upon request). We have done some 
evaluations of the drape on non-study controlpatients. We had three 
nurses apply the drapes to themselves and other volunteers to 
evaluate its wearability and painless release, comparing the response 
to other multipleotherdrapes, including our Control drape. The GBT 
drape demonstrated a strong adhesive bond lasting for at least3 days 
and released when triggered, painlesslywithno skin irritationorinjury. 
Attachedisa 
folderwiththe 
GBT 
drape(designated 
asS-2747) 
testingdata. Appropriate FDA biocompatibility studies, o f t h e 
GBT d r a p e including animal skin sensitization, skin irritation 
and cytotoxicity were successfully completed. 
 
Other GBT adhesiveproduct testing included:aUPMC Presbyterian 
Hospital study finds preference of Comfort Release® bidirectional, 
transparent tape compared to the Market Leading transparent tape 3M 
Transpore™. This study was a product evaluation comparing the 
use of Comfort Release® bidirectional,transparent tapeto the market 
leadingtransparenttape used at theUPMC Presbyterian Hospital in 
Pittsburgh. The 100-patient study included individuals aged 20-84, 
59% female and 39% male (2% preferred not to say). The VAT-IV 
team was responsible for applying the tapes for skin securement 
and the nursing staff was responsible for removing the tape and 

 
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completing a corresponding survey. Prior to removing Comfort 
Release®, tape nurses were queried on prior experiences with 
patient tape removal including the type of tape most often encountered 
and how often patientsexperiencedpain, redness, and erythemaduring 
the process. Nurses were then instructed to remove the tape by swiping 
the outside with alcohol prep pads and were asked a series of follow 
up questions related to the activity. These included patient-centered 
questions such as their perceived pain during the removal process 
as well as usability questions such as time spent removing the tape 
and utility of the tape. Throughout the study, length of tape 
application time ranged from 24-72 hours depending on the patient. 
To increase enrollment of patients undergoing phlebotomy on the 
study, additional facility units were also added. Key study findings 
were 
as 
follows: 
Nurses 
expressed preference 
forComfort 
Release®Tape over 3M Transpore Tape and report patients also had 
favorable opinions towards the Comfort Release® tape. Overall 
conclusions from 100 nursing staff responses: 
 
• Nurses overwhelminglyprefer Comfort Release® tape over 3M 
Transpore Tape. Only one nurse from the 100 favored the 3M 
product. 
• 98% of nurses surveyed responded that Comfort Release® was 
as good or better than current dressings. 
• 90% of nurses reported that Comfort Release® is easy to apply and remove. 
• Every 9 of 10 nurses indicated that their patient 
willdirectlybenefit fromthe use of Comfort Release® Tapes. 
 
Comfort Release® tape had a low rate of skin response. Nursing staff 
report that the incidence of medical adhesive skin injury (from tape 
removal) ranged between 30% and 50% of allpatients,using current tape 
products at UPMC(3M Transpore Tape).However, the same nursing 
staff reportedthe occurrence of medicaladhesive skin injury in the 100 
test patients was less than 10%. In total, 85% of patients tested had no 
skin response and 3% had only a faint response (measured by 
erythema).Comfort Release® Tape resulted in minimal t o n o pain 
to patients. Critically, 71% had no pain and 17% had only minimal 
pain or an unpleasant sensation. Clinical Surveys demonstrated 
user satisfaction with Comfort Release®. 
 
 
Clinical Surveys demonstrate user satisfaction with other Comfort 
Release® adhesive products. 
 
Nurse Evaluation. A focus group and product evaluation of Comfort 
Release® was performed by eight nurses of varying levels of 
experience. All nurses had prior experiences with IV site dressing, 
and all but one nurse had experience with border dressings and 
medicaltape. Prior to beginning product testingparticipating nurses 
were asked a series of questions before being introduced to the 

 
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Comfort Release® products. Preliminary survey questions found that 
89% agreed that trauma to a wound (or surrounding area) often 
occurs while removing a bandage/dressing (compared to 11% 
disagree);78% agreed that removal of bandages is a significant problem 
in wound care management, and 89% agreed patients complain of 
pain during dressing/bandage removal. After seeing, testing, and 
trying our product, 100% of surveyed nurses agreed that Comfort 
Release® would likely: decrease pain and trauma associated with dressing 
removal; decrease the frequency of skin tears; and improve patient 
comfort during dressing removal. 
 
Adult Patient evaluation. A total of n=100 adult patients were recruited 
to participate in a product evaluation of Comfort Release® bandages 
over the course of 2-3 days. The primary outcomes of this study were 
skin sensitivity responses to the bandage and/or IPA), durability of the 
bandage, and occurrence of adhesive residue. Participants were asked 
a series of questions before and after wearing sample Comfort 
Release® bandages during the study period. They were given limited 
background information and simple label instructions for use. All 
signed normal consent to participate in the evaluation. None were 
paid. Of those surveyed, 95% had prior experience with bandages 
and tapes (compared to 5% disagree); 78% reported that all other 
bandages fall off with simple bathing (compared to 12% disagree & 
10% don’t know); and 80% agree they are dissatisfied with other 
bandages and tapes (compared to 20% disagree).After trying the 
Comfort Release® Bandage, 99% reported Comfort Release® 
stayed on (90% for full test period of 48 or 72 hours, 9% for 24-36 
hours, and 1% less than 12 hours), 88% agreed Comfort Release® 
easily removed with rubbing alcohol (compared to 9% disagree and 
3% details not provided), and 94% agreed Comfort Release® left no 
glue residue (compared to 6% who reported minimal residue). After 
seeing, testing, and trying our product,94% of adult patients agreed 
they were satisfied with Comfort Release®. 
  
Child Patient Evaluation. Comfort Release® Bandages were also 
tested in a group of n=100 children at a pediatric medical practice. 
Each of our 100 child participants and their consenting adults were 
asked to provide answers about their experience with other adhesive 
products and with the results of using Comfort Release samples. 
All consenting adults signed a written consent, and each child 
received an incentive to participate. Of those surveyed, 94% had 
prior experience with bandages and tapes (compared to 6% 
disagree),81% agree that all other bandages fall off too easily 
(compared to 19% disagree), 93% agree that all other bandages fall 
off with simple bathing (compared to 7% disagree), and 84% agree 
all other bandages are painful to remove(compared to 16% 
disagree).86% of children had Comfort Release® bandages on for 

 
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the full test period — all of which easily removed their bandages 
with rubbing alcohol swipe— 86% of children easily removed their 
Comfort Release® bandages with rubbing alcohol (compared to 14% 
that did not need the alcohol), 86% removed Comfort Release® with 
no glue residue left on skin (compared to 14% with minor residue left 
after bandage removal), and 94% agreed Comfort Release® was not 
painful to remove (compared to 6% reporting slight discomfort). 
After seeing, testing, and trying our product, 94% of children and 
their parents agreed they would purchase Comfort Release®. 
 
 
4. INVESTIGATIONAL PLAN 
 
4.1. PURPOSE 
NPWT is commonly used for the management of more than 100 
indications, including chronic wounds, acute open wounds, burns, and 
post operative sites. An estimated 6.5 million patients suffer from 
chronic wounds and an estimated 48 million inpatient surgeries are 
performed each year in the US3,4. NPWT involves covering a wound 
with an airtight dressing, sealed by adhesive, and applying sub-
atmospheric pressure via a vacuum device. Strong adhesives are 
typically required for NPWT drapes. Exudate can leak with weaker 
adhesives, tainting peri-wound skin, causing loss of drape adherence, 
subsequently leading to the potential for macerated tissue, increased 
wound size, and slower or reduced healing. However, strong adhesives 
substantially increase the risk for medical adhesive-associated skin 
injuries (MARSI) during drape removal/changes. Drape removal can 
cause epidermal layers to separate and/or detach from the dermis, 
resulting in skin tears and moisture-associated skin damage, and skin 
irritation. Studies show the type of drape used correlates with acute 
pain during dressing changes and injury to the peri-wound tissue, in 
turn delaying the wound healing process. Previous attempts to develop 
a product with strong adhesion and easy removability have fallen short. 
Silicone adhesives have poor skin adherence and are expensive, thus 
requiring stronger adhering acrylic sealing strips or other acrylic 
components to mitigate leaks. Addressing this unmet need, Global 
Biomedical Technologies has developed an adhesive acrylic NPWT 
drape incorporating innovative ester oligomers that release from the 
skin with the addition of isopropyl alcohol. This painless adhesive 
technology, “Comfort Release®,” has proven high patient satisfaction 
with low incidence of MARSI. This project will confirm the superior 
functionality and acceptability of Comport Release® NPWT drapes 
against the market leader (V.A.C. drape by KCI Technologies, Inc.) or 
standard NPWT drape in both single-use and serial-use NPWT 
applications. The data obtained from this Direct to Phase II project is 
expected to support a 510K FDA clearance. 
 
The proposed research aims to provide the clinical validation and data 

 
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needed for 510K FDA clearance. If successful, the knowledge gained 
as a result of this trial can bring to market a novel surgical drape for 
wound therapy that has strong potential to be painless and atraumatic 
and will help facilitate wound healing and prevent adhesive related 
secondary skin injuries. This can potentially contribute to improved 
patient outcomes. Given that there are minimal risks in this trial we 
find them reasonable to obtain the knowledge and clinical data needed 
to bring this drape to pursue FDA clearance and bring this novel 
NPWT drape to market. 
 
Aim 1: Compare performance of Comfort Release® drapes with 
control NPWT drapes in single-use NPWT applications in a 
randomized controlled trial. Single use negative pressure wound 
therapy is used after post-surgical procedures. 
 
Aim 2: Compare performance of Comfort Release® drapes with 
control NPWT drapes in serial-use NPWT applications in a 
randomized controlled trial. Serial use negative pressure wound therapy 
is used with patients with chronic wounds. 
 
 
 
4.1.1 PRIMARY EFFECTIVENESS ENDPOINT 
Primary effectiveness will be determined by patient improvement 
and satisfaction and by product acceptance by the clinicians 
involved in the study. 
 
Measurements between Comfort Release® test drape and the 
control drape used in the clinical study should demonstrate a: 
 
1) Decrease incidence of medical adhesive-related skin irritation 
and injuries following drape removal. 
 
2) Decrease patient discomfort and pain during the drape removal. 
 
3) Decrease use of medications for anxiety, pain and stress related to drape removal. 
 
4) Maintaining a vacuum seal with a leak incidence rate that is 
as low or lower than the control drape. 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Brief Description 
At time of removal, clinicians will assess associated skin irritation and 
injuries by using the MARSI classification scale. 
Participating clinicians will be trained (led by Denise Anderson, RN, WCC) 
on how to identify and measure MARSI across presentations (including 
erythema lasting 15-30 minutes, skin tears, skin stripping, folliculitis, 
maceration, tension/injury blister, allergic contact dermatitis, and irritant 
contact dermatitis). All incidences of MARSIwill be recorded. 
Clinicians will ask patients to assess pain using the Indiana Polyclinic 
Combined Pain Scale. Instances of patients prematurely stopping 
treatment will be recorded. 
Patient use of narcotics, pain and stress-reducing medications prescribed to 
patients undergoing the drape removal will be recorded throughout the 
duration of the study. 
During the NPWT application, clinicianswillbe instructed to record any 
incidence of vacuum leaks (as alerted by vacuum pump machine) that occur 
as a result of unsealed adhesive. 
  
 
 
 
 

 
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4.1.2 SAFETY ENDPOINTS 
 
Completion of the Negative Pressure Therapy treatment plan as 
established by ordering physician. 
 
Treatment and resolution of any medical adhesive related skin 
injuries from the drape removal in both control and study patients. 
 
  
4.1.3 SECONDARY EFFECTIVENESS ENDPOINT 
 
Secondary effectiveness will be determined by healthcare 
professionals’ use of both drapes. 
 
Use of Comfort Release® drape will be compared to control drape 
use in the clinical study and should demonstrate: 
 
1) Clinician acceptability of the Comfort Release® drape. 
 
2) Less time to remove the Comfort Release® NPWT drape and the 
economic value of less time of the healthcare professional spent on 
the drape removal activity. 
 
3) Measurement of patient rate drop-out (or refusal) to continue and 
finish their NPWT therapy prescribed by their treating physician 
  
4.2 PROTOCOL 
Negative pressure wound therapy (NPWT) is a common primary or 
adjunctive treatment approach for more than 100 indications, 
including chronic complex wounds that are potentially non-healing, 
and acute open wounds that are infected or subject to swelling, severe 
burns, and post operative care. Despite demonstrated benefits of 
NPWT, the technology faces challenges regarding the adhesive sealant 
component of the system as the strong adhesive required to establish 
and maintain an airtight seal for successful implementation of NPWT 
substantially increases the chances for mechanical skin injury. 
Addressing this, Global Biomedical Technologies will compare 
Comfort Release® NPWT drape - an innovative “switchable adhesive” 
technology for painless and trauma free removal, with the standard 
NPWT drape, typically KCI V.A.C.® drape, in post-surgical wound 
patients. The types of post-op wounds that receive NPWT that are 
eligible for this study include adult acute wounds and incisions, as well 
as chronic wounds and burns. 
 
 
 
 
 
 

 
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In Aim 1, we will evaluate drape performance in post-surgical single-
use NPWT, where the approach will be used to treat surgical sites 
(e.g. skin closures and skin grafts), a common occurrence at the 
clinical study sites. 
 
Aim 1: Compare performance of Comfort Release® drapes with 
standard drapes in single-use, or short-term NPWT applications in a 
randomized controlled trial. Post-surgical patients (n=100) with 
prescribed NPWT, will be enrolled at Weill Cornell under PI. Dr. 
Robert Winchell, at Columbia Presbyterian hospital under co-
Principal Investigator Dr. Jarrod Bogue, and at Absolute Medical 
Center under co-Principal Investigator Dr. Daniel Careaga. Patients 
will be randomized to a single use control (standard drape) or 
intervention (Comfort Release® drape). All other components of the 
NPWT device including but not limited to the pump, tubing, foam or 
dressing insert will be identical. 
 
Aim1 Testing Protocol 
1) measurement of medical adhesive-related skin irritation and 
injuries, as measured by the Medical Adhesive-Related Skin Injury 
(MARSI) classification scale. 
2) measurement of pain, as measured by the Indiana Polyclinic Combined Pain Scale. 
3) measurement of the use of medications for pain and stress related to 
dressing removal. 4) measurement of the effectiveness in maintaining 
seal (leak incidence rate). 
5) measure clinician acceptability of the Comfort Release® drape. 
6) measurement of patient drop-out from the prescribed length of the NPWT 

 
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therapy prescribed by treating physician. 
 
In Aim 2, we will evaluate the drape performance in serial-use NPWT; this 
course of treatment is commonly used for numerous types of wounds 
including burns, pressure ulcers, fasciotomy sites, and other post-traumatic 
indications. 
 
Aim 2: Compare performance of Comfort Release® drapes with V.A.C. drapes in serial-use 
NPWT applications in a randomized controlled trial. Chronic wound patients (n=100) with 
prescribed NPWT will be enrolled at Weill Cornell Medical Center under Principal Investigator Dr. 
  
Robert Winchell and at Vital Medical Research under co-Principal Investigator, Deeva Frankel, 
DPM, D.ABFAS 
All patients will undergo approximately 3 NPWT drape changes per 
week (or as ordered by provider). Patients will be randomized to 
control (standard drape.) or intervention (Comfort Release® drape) for 
the duration of their study enrollment. All other components of the 
NPWT device including but not limited to the pump, tubing, foam or 
dressing insert will be identical. 
 
Aim 2 Testing Protocol 
1) measurement of medical adhesive-related skin irritation and 
injuries, as measured by the Medical Adhesive-Related Skin Injury 
(MARSI) classification scale. 
2) measurement of pain, as measured by the Indiana Polyclinic Combined Pain Scale. 
3) measurement of the use of medications for pain and stress related to 
dressing removal. 4) measurement of the effectiveness in maintaining 
seal (leak incidence rate). 
5) measure clinician acceptability of the Comfort Release® drape. 
6) measurement of the time to remove the NPWT drape and any 
economic value through change in clinician time spent in the activity. 
7) measurement of patient drop-out from the prescribed length of 
the NPWT therapy prescribed by treating physician. 
 
Clinicians, including nurses, physicians, residents, and physician 
assistants will be trained to use the investigational drape and record 
data on patient reactions to the Comfort Release® Drape and the 
standard drape. Clinicians will be asked to evaluate the ease of 
learning and using the new drape. Training on using the Comfort 
Release® Drape and rating skin injuries according to the Medical 
Adhesive-Related Skin Injury (MARSI) classification scale will be 
provided through online videos and, if needed, on-site sessions 
 
Comfort Release® Drape applies to the skin like most standard NPWT 
drape, with the exception of a tab that remains attached to the drape on 
the patient’s skin. The tab assists in the removal of the drape at the 
time of dressing removal. Comfort Release® removal is different than 

 
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other drapes because isopropyl alcohol (or common rubbing alcohol) 
is needed to switch the adhesive bond from the skin off. 
 
A detailed step by step device instruction is in the PDF below or refer to GB141-A IFU. 
 
(Please see the attached PDF of GB141-A – Pouch Label) 
 
Aim 1 Initial Visit 
 
Step 1) Compare inclusion/exclusion criteria to find eligible 
participants and record them on the case report. 
 
Inclusion Criteria: 
1. 18 years or older post-surgical inpatients with a plan of 
treatment using NPWT. 2. Able to communicate and consent to 
participate in the study. 
3. Access to the standard drape and NPWT kits. 
 
4. Able to report pain level using a pain scale. 
5. If outpatient, participants must return to the clinic for all dressing changes 
to be performed under the supervision of study-trained clinical professionals. 
 
Exclusion Criteria: 
1. History of known hypersensitivity to acrylic 
adhesives. 2. History of known hypersensitivity 
to isopropyl alcohol. 
3. The patient is expected to be unconscious during the drape 
removal/change. 4. Under the age of 18 years 
6. Unable to give consent, including language barrier, unless an 
interpreter is readily available. 
 
Step 2) Willing participants sign consent, signing is witnessed, and in a 
timely matter and is then co-signed by site PI. 
 
Step 3) Subject is assigned an identification code number. Date, 
subject initials, ID, DOB, gender at birth, ethnicity, eligibility, 
medications, and health history are recorded on case report forms. 
 
Step 4) The Site PI or a designated individual will email the 
Program Coordinator, Denise Anderson, RN, WCC at: 
danderson@comfortrelease.com, call, or text at (352) 397-8810 to 
receive the next subject ID number from the sponsor’s randomized 
list. As backup, you may also contact Dr. Howard Rosing at 
(239)330-5646. 
 
After-Hours Procedure (or if a timely response is not available): 
 
1. If warranted, an emergency backup list of Participant IDs will be 
provided to your site. o You must select the next unused ID in 
sequence. 
2. Log in to ClinCapture EDC and register the participant 

 
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using that ID. 3. When entering the participant, select the 
appropriate Study Aim: 
o Aim 1 – Single or short-term NPWT use following post-
surgicalincisionalclosure or graft placement. 
o Aim 2 – Chronic wounds requiring multiple NPWT applications. 
4. Immediately send an email to grant@comfortrelease.com 
with the following: o Subject line: “ID used – facility 
name or ID- Aim 1 or Aim 2. 
o Email body: Include the ID used and the actual or anticipated date 
of first dressing application. 
 
Randomized subject ID numbers beginning with 1-XXXX are control 
participants (standard drape), and randomized subject ID numbers 
beginning with 0-XXXX are study participants (Comfort Release® 
drape). 
 
a. Randomize patients- 1/2 of the patients to receive the standard 
drape and 1/2 to receive Comfort Release drape. 
0-XXXX = Study drape (Comfort 
Release®) 1-XXXX = Control drape 
(standard) 
 
Step 5) Complete the demographic, medical history, and concomitant medication case report forms 
 
Step 6) Drape Application Procedure 
 
A. Comfort Release® Drape Application Procedure 
• After the wound has been appropriately covered with 
foam dressing per NPWT standard protocol, apply the 
drape over the foam and to clean, dry, intact periwound 
skin. 
• Cover the sponge completely with the drape, ensuring 
at least 1–2 inches of overlap onto intact periwound 
skin. 
• When cutting the drape to fit over the wound, maintain 
at least one edge with a portion of the blue Tab #3 
(Directions Tab) intact. 
• Remove Layer #2 from the drape. 
• To remove the blue handling tab(s): 
o Hold the drape side of the perforation steady with one hand.  
o Use the other hand to peel and remove the blue Tab #3 along 
the perforation line. 
o A portion of the tab will remain on the drape and is intended to assist with drape  
         removal later. 
• Gently pat down the drape to secure the seal. 
• Proceed with the site’s standard NPWT procedures to 
connect the drape and foam dressing to the pump. 
 
 

 
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B. Control Drape Application Procedure 
• After the wound has been appropriately covered with 
foam dressing per standard protocol, apply the control 
drape to clean, dry, intact skin only. 
• Follow the site’s standard operating procedure for 
application of the control drape. 
• Proceed with the site’s standard NPWT procedures to 
connect the drape and dressing to the pump. 
 
 
Step 7) Fill in the information and answer questions regarding 
drape application: 1. Record wound location and 
measurements. 
2. Which drape was applied? 
3. Was the drape easy to apply? 
4. Were the drape application instructions easy to follow? 
 
 
Drape Removal Visit 
 
Step 1) Update Concomitant Medication Case Report Form 
 
Step 2) Drape Removal Procedure 
 
A. Comfort Release® Drape 
•     Lift the Directions Tab and gently swipe isopropyl alcohol prep 
pads or swab sticks underneath the edge of the drape. 
•     Continue wetting the underside of the drape where it adheres to the 
skin, using additional alcohol pads or swab sticks as needed, until the 
drape lifts easily from the skin. 
B. Control Drape 
•     Remove the drape according to the site’s standard protocol for 
traditional NPWT dressing removal. 
 
Step 3) Pain Assessment 
•     Use the Indiana Polyclinic Combined Pain Scale to assess the participant’s pain. 
o Do not use the numeric scale alone. Instead, rely on the verbal 
descriptors provided in the scale to obtain a more accurate 
understanding of the participant’s experience. 
•     Carefully remove all remaining drape 
•     Document removal per standard operating procedures. 
  
Step 4) Periwound Skin Assessment 
•     Assess and score the periwound skin using the MARSI 
Classification Scale provided below. 
•     If any skin injury is observed, follow the timing guidelines below: 
o Score 1–2: Evaluate the skin again in approximately 
15 minutes. o Score 3–4: Evaluate the skin again in 
approximately 30 minutes. 

 
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•     Record all findings in the appropriate fields on the case report form. 
  
Step 5) Drape Removal Questions:  
a. Which drape was removed?  
b. Was the drape easy to remove? 
c. Were the drape removal instructions easy to follow? 
d. Was pain or anxiety medication given to the participant due 
to pain or discomfort experienced during drape removal? 
Record any medications given. e. Did the drape maintain an 
effective seal during the course of use? 
f. Use the additional notes section to explain any issues 
with the drape maintaining a seal or for any other 
treatment complications. 
g. Is the patient dropping out of the prescribed treatment? 
• If yes, please specify in the comments section the 
reason for the subject dropping out of treatment or 
write unknown if the reason is not available. 
 
Note: 
In the rare event that a second or third application of NPWT is used, the metrics from the second  
or third application will be measured, and the participant will remain in the study. 
  
Aim 2 Initial Visit 
 
Step 1) Compare inclusion/exclusion criteria to find eligible 
participants and record them on the case report. 
 
Inclusion Criteria: 
1. 18 years or older post-surgical inpatients with a plan of 
treatment using NPWT. 
2. Able to communicate and consent to participate 
in the study. 3. Access to the standard drape and 
NPWT kits. 
4. Able to report pain level using a pain scale. 
5. If outpatient, participants must return to the clinic for all 
drape changes to be performed under the supervision of study-
trained clinician. 
 
Exclusion Criteria: 
1. History of known hypersensitivity to acrylic adhesives. 
2. History of known hypersensitivity to isopropyl alcohol or 
rubbing alcohol. 3.The patient is expected to be unconscious 
during multiple drape removals/changes. 
4. Under the age of 18 years. 
5. Unable to give consent, including language barrier, unless 
an interpreter is readily available. 
 
 

 
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Step 2) Willing participants sign consent, signing is witnessed, and in 
a timely matter is co-signed by PI. 
 
Step 3) Subject is assigned an identification code number. Date of 
evaluation, subject initials, ID, DOB, gender, ethnicity questions, and 
eligibility evaluation are recorded on case report form. 
 
Step 4) The Site PI or a designated individual will email the 
Program Coordinator, Denise Anderson, RN, WCC at: 
danderson@comfortrelease.com, call, or text at (352) 397-8810 to 
receive the next subject ID number from the sponsor’s randomized 
list. As backup, you may also contact Dr. Howard Rosing at 
(239)330-5646. 
  
After-Hours Procedure (or if a timely response is not available): 
 
1. If warranted, an emergency backup list of Participant IDs will be 
provided to your site. o You must select the next unused ID in 
sequence. 
2. Log in to ClinCapture EDC and register the participant 
using that ID. 3. When entering the participant, select the 
appropriate Study Aim: 
o Aim 1 – Single or short-term NPWT use following post-
surgicalincisionalclosure or graft placement. 
o Aim 2 – Chronic wounds requiring multiple NPWT applications. 
4. Immediately send an email to grant@comfortrelease.com 
with the following:  
o Subject line: “ID used – facility name or ID -Aim1or Aim 2 
 
o Email body: Include the ID used and the actual or anticipated date 
of first dressing application. 
 
Randomized subject ID numbers beginning with 1-XXXX are control 
participants (standard drape), and randomized subject ID numbers 
beginning with 0-XXXX are study participants (Comfort Release® 
drape). 
 
a. Randomize patients- 1/2 of the patients to receive the standard 
drape and 1/2 to receive Comfort Release drape. 
 
0-XXXX= Study drape  (Comfort Release®)  
1-XXXX = Control drape 
 
Step 5) Complete medical history, and concomitant medication CRFs. 
  
Step 6) Drape Application Procedure 
  
 

 
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A. Comfort Release® Drape Application Procedure 
• After the wound has been appropriately covered with 
foam dressing per standard protocol, apply the drape to 
clean, dry, intact skin only. 
• Cover the sponge completely with the drape, ensuring 
at least 1–2 inches of overlap onto intact periwound 
skin. 
• When cutting the drape to fit over the wound, maintain 
at least one edge with a portion of the blue Tab #3 
(Directions Tab) intact. 
• Remove Layer #2 from the drape. 
• To remove the blue handling tab(s): 
o Hold the drape side of the perforation steady with one hand.  
o Use the other hand to peel and remove the blue Tab #3 along 
the perforation line. 
o A portion of the tab will remain on the drape and is intended to assist with drape  
         removal later. 
• Gently pat down the drape to secure the seal. 
• Proceed with the site’s standard NPWT procedures to 
connect the drape and foam dressing to the pump. 
 
B. Control Drape Application Procedure 
• After the wound has been appropriately covered with 
foam dressing per standard protocol, apply the control 
drape to clean, dry, intact skin only. 
• Follow the site’s standard operating procedure for 
application of the control drape. 
• Proceed with the site’s standard NPWT procedures to 
connect the drape and foam dressing to the pump 
 
Step 7) Fill in the information and answer questions 
regarding drape application: 
1. Record wound location and measurements.  
2. Which drape was applied? 
3. Was the drape easy to apply?  
4. Were the drape application instructions easy to follow? 
  
Aim 2 
Drape Removal Visit 
 
Step 1) Update Concomitant Medication Case Report Form 
 
Step 2) Drape Removal Time 
• Record the total time taken (in minutes) to remove the drape. 
• Enter this value in the appropriate field on the case report form. 
  
Step 3) Drape Removal Procedure 
 
 

 
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A. Comfort Release® Drape 
•     Lift the Directions Tab and gently swipe isopropyl alcohol prep 
pads or swab sticks underneath the edge of the drape. 
•     Continue wetting the undersideof the drape where it adheres to the 
skin, using additional alcohol pads or swab sticks as needed, until the 
drape lifts easily from the skin. 
 
B. Control Drape 
•     Remove the drape according to the site’s standard protocol for 
traditional NPWT dressing removal. 
 
Step 4: Pain Assessment 
 
    •     Use the Indiana Polyclinic Combined Pain Scale to assess the participant’s pain. 
o Do not use the numeric scale alone. Instead, rely on the verbal 
descriptors provided in the scale to obtain a more accurate 
understanding of the participant’s experience. 
        •     Carefully remove all remaining dressing components.  
      •     Document removal per standard operating procedures. 
  
Step 5) Periwound Skin Assessment 
•     Assess and score the periwound skin using the MARSI 
Classification Scale provided below. 
•     If any skin injury is observed, follow the timing guidelines below: 
o Score 1–2: Evaluate the skin again in approximately 
15 minutes. o Score 3–4: Evaluate the skin again in 
approximately 30 minutes. 
•     Record all findings in the appropriate fields on the case report form. 
 
Step 6) Drape Removal 
Questions a. Which drape 
was removed? 
b. Was the drape easy to remove? 
c. Were the drape removal instructions easy to follow? 
d. Was pain or anxiety medication given to the participant for pain or discomfort 
                   experienced due to drape removal? Record any medication used. 
e. Did the drape maintain an effective seal during the course of use? 
f. Use the additional notes section to explain any issues with the 
drape maintaining a seal or for any other treatment complications. 
g. Is the patient dropping out of the prescribed treatment? 
• If yes, please specify in the comments section the reason 
for the subject dropping out of treatment or put unknown. 
 
 
 
 
 
 
 

 
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Indiana Polyclinic Combined Pain Scale 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Medical Adhesive-Related Skin Injury (MARSI) classification scale 
 
MARSI Classification Form 
Instructions for Use: 
 
• Initial Evaluation: Clinicians assess the skin under the drape immediately after the drape is removal  
and check the appropriate box based on the severity of each skin injury. 
 
• If any skin injury is observed, follow the guidelines below: 
For any score 1-2, reassess the skin in approximately 15 minutes, record results  
For any score 3-4, reassess the skin in approximately 30 minutes, record results 
 
 
Skin Injury Type 
1. Erythema 
(Redness) 
 
 
 
 
2. Skin Stripping 
 
 
 
 
3. Tension Blisters 
 
 
 
4. Maceration 
 
 
 
5. Contact 
Dermatitis 
Initial Evaluation (0–4) 
0 = No redness □ 1 = 
Very slight redness □ 2 
= Well-defined redness 
□ 3 = Moderate □ 4 = 
Severe redness □ 
0 = No stripping □ 1 = 
Very slight stripping □ 2 
= Partial epidermal loss 
□ 3 = Full-thickness □ 4 = 
Severe stripping □ 
0 = No blisters □ 1 = Very 
small blister □ 2 = Small 
blister □ 3 = Large blister 
□ 4 = Severe blister □ 
0 = No maceration □ 1 = 
Very slight softening □ 2 = 
Mild softening □ 3 = 
Moderate □ 4 = Severe □ 
0 = No reaction □ 1 = 
Slight 
30-Minute Evaluation 
(0–4) 0 = No redness □ 1 
= Very slight redness □ 2 
= Well-defined redness 
□ 3 = Moderate □ 4 = 
Severe redness □ 
0 = No stripping □ 1 = 
Very slight stripping □ 2 
= Partial epidermal loss 
□ 3 = Full-thickness □ 4 = 
Severe stripping □ 
0 = No blisters □ 1 = Very 
small blister □ 2 = Small 
blister □ 3 = Large blister 
□ 4 = Severe blister □ 
0 = No maceration □ 1 = Very 
slight softening □ 2 = Mild 
                                                                     
softening □ 3 = Moderate □ 4 
= Severe □ 
0 = No reaction □ 1 = Slight 
 
reaction □ 2 = 
Moderate reaction □ 3 
= Severe reaction □ 4 = 
Severe with vesicles □ 
6. Folliculitis 
0 = No inflammation □ 
1 = Mild irritation □ 2 = 
Moderate irritation □ 3 
= Severe inflammation 
□ 4 = Infected □ 
 
 
reaction □ 2 = 
Moderate reaction □ 3 
= Severe reaction □ 4 = 
Severe with vesicles □ 
0 = No inflammation □ 
1 = Mild irritation □ 2 = 
Moderate irritation □ 3 
= Severe inflammation 
□ 4 = Infected □ 
 
 
 
 
 
                                     
 
 
 
 
 
 

 
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4.2.1 OVERVIEW 
This is a nonblinded study to measure the following, in two 
randomized groups: ½ of the study patients that have 
prescribed NPWT will receive the standard of care NPWT 
drape and ½ of the patients will receive the NPWT Comfort 
Release drape. 
 
Skin irritation and skin injury: At time of removal, clinicians 
will assess associated skin irritation and injuries using the 
MARSI classification scoring system. Briefly, the clinician will 
utilize the four-point scoring system for 1) erythema, (scale 
ranks from no erythema (0) to severe erythema (4). 
Participating clinicians will be trained (led by Clinical 
Research Coordinator, Denise Anderson, RN, WCC) on how to 
identify and measure MARSI across presentations. For any 
score 1-2, reassess the skin in approximately 15 minutes, 
record results. For any score 3-4, reassess the skin in 
approximately 30 minutes, record results All incidences of 
MARSI will be recorded. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Table: Description of MARSI Injury 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Pain: Taking repeated measures of pain is best practice for pain 
intensity measurement. Immediately prior to adhesive removal 
clinicians will ask patients to assess pain using the Indiana 
Polyclinic Combined Pain Scale and record a baseline pain 
measure. This will then be repeated during and immediately 
after adhesive removal. This ten-point scale provides criteria for 
each score, ranging from “No pain” (0) to “Worst Imaginable – 
Paralyzing; person is in and out of consciousness and near death 
as a result of the pain. Emergency medical attention and 
hospitalization are required”. 
 
Treatment compliance: Patient treatment plan adherence is 
a known challenge with NPWT. In this study we will assess 
patient compliance to the prescribed NPWT. Instances of 
patients prematurely stopping treatment will be recorded. 
 
Medication use: Patient use of narcotics, pain, and stress 
reducing medications prescribed to patients undergoing the 
dressing removal will be recorded throughout the duration of 
the study. These data will be used to assess any differences in 
usage between the two treatment groups. 
 
Leak rate: During the NPWT application clinicians will be 
instructed to record any incidence of leaks (as alerted by 
vacuum pump machine) that occur as a result unsealed 
adhesive. With any leak, the clinicians will record steps to 
remediate the leak (e.g., applying additional adhesive strips). 
and homogenous variance will be assessed visually using plots of the model residuals. 
 
Clinician acceptability Questions provided to clinician at each dressing removal. 
 
Economic Analysis: Using collected data from serial-use 
application participants (patient chart data, clinical surveys), 
we will perform an economic analysis to evaluate the potential 
for time added value with Comfort Release® drapes compared 
to standard of care. Variables that will be included in the 
analysis include clinician time; cost of materials; medication 
use cost; and length of treatment period. 
  
4.2.2 SAMPLE SIZE DETERMINATION 
Sample Size Justification for Aim1, single-use NPWT: 
Sample sizes of 100 patients per randomization group (n=50 patients 
per randomization group) will allow for a standardized mean difference 
of 0.4 between the treatment groups to be considered 
statistically significant at an α = 0.05 level with 80% power. An 
effect size of d = 0.4 is considered a moderate effect size and 
would translate to a mean difference of 1 unit on the MARSI 

 
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classification scoring system assuming a within group standard 
deviation of 2.5; and a mean difference of 4 units on the 
Indiana Polyclinic Combined Pain Scale assuming a within 
group standard deviation of 10. 
  
Sample Size Justification for Aim2, multi-use NPWT: 
 Sample sizes of 50 patients per randomization group will allow for an overall standardized mean 
difference of d = 0.6 between the treatment groups to be considered statistically significant at an α = 
0.05 level with 80% power. An effect size of 0.6 is considered a moderate effect size and would 
translateto a mean difference of 1.5 units on the MARSI classification scoring system assuming a 
within group standard deviation of 2.5; and a mean difference of 6 units on the Indiana Polyclinic 
Combined Pain Scale assuming a within group standard deviation of 10. We expect a larger effect 
size in Aim 2 patients than patients than the Aim 1 patients because the rate of MARSIis much 
higher in serial-use NPWT applications. 
 
 
4.2.2.1 STATISTICAL METHODS 
Statistical Analysis: 
For single-use NPWT, measures of skin irritation,injuries, 
and pain will be analyzed using linear models to compare 
Comfort Release® drapes with the standard drapes while 
controlling for gender, age,facility, and other relevant patient 
comorbidities. All hypothesis tests will be two-sided and p-
values <0.05 will be considered statistically significant. 
Model assumptions of normality and homogenous variance 
will be assessed visually using plots of the model residuals. 
 
For serial-use NPWT, measures of skin irritation and injuries and 
pain collected repeatedly after each drape change will be 
analyzed using linear mixed models to compare Comfort 
Release® drapes with the standard drapes. Fixed effects will 
include treatment group (intervention vs. control), time, an 
interaction between treatment group and time, gender, age, and 
other relevant patient comorbidities. Models will include a 
random effect of the patient id to controlfor the repeated 
measurements taken on patients over time. All hypothesis tests 
will be two-sided and p-values <0.05 will be considered 
statistically significant. Model assumptions of normality and 
homogenous variance will be assessed visually using plots of the 
model residuals. 

 
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4.2.2.1.1 SUBJECT POPULATION FOR ANALYSIS 
Aim1. 
Post-surgical inpatient participants (n=100) prescribed NPWT 
by the treating physician will enroll in this study. Any patient 
meeting the inclusion criteria of: patient is 18 years or older, 
scheduled for non-emergency surgery; a plan of treatment using 
NPWT; access to standard drape and NPWT kits; patient ability 
to verbally communicate are eligible, and if outpatient, 
participants must return to the clinic for all dressing changes to be 
performed under the supervision of study-trained clinical 
professionals. Exclusion criteriainclude known hypersensitivity 
to acrylic adhesives; known hypersensitivity to isopropyl 
alcohol; unconscious patientduring the expected time of the 
drape removal/change; under the age of 18 years; unable to give 
consent; and language barrier, unless interpreter is readily 
available. 
 
Aim2. 
Chronic wound patients (n=100) prescribed NPWT will be 
enrolled in this study for inpatient serial use NPWT 
applications. Inclusion criteria are: patient is 18 years or older, 
NPWT recommended by the treating physician; a plan of 
treatment using NPWT; access to the standard drape and NPWT 
kits; patient ability to verbally communicate, and if outpatient, 
participants must return to the clinic for all dressing changes to be 
performed under the supervision of study-trained clinical 
professionals. Exclusion criteria include known hypersensitivity 
to acrylic adhesives; known hypersensitivity to isopropyl 
alcohol or rubbing alcohol, unconscious patient during the 
expected time of the drape removal/change; under the age of 18 
years; unable to give consent; and language barrier, unless 
interpreter is readily available. 
 
4.2.2.1.2 PRIMARY ANALYSIS METHOD 
For single -use NPWT: 
To demonstrate that compared to market leader (standard 
drapes), patients with the Comfort Release® drapes have 
statistically significant (α=0.05): 1) decreased medical 
adhesive-related skin irritation and injuries, as measured by the 
MARSI scoring system, 2) lower experience of pain, as 
measured by the Indiana Polyclinic Combined Pain Scale, 3) 
decreased use of medications for pain and stress related to 
dressing removal, 4) demonstrate equivalent or improved 
effectiveness in maintaining seal compared to control (leak 
incidence rate), and 5) establish clinician acceptability of the 
Comfort Release® drape: average questionnaire scores >4. 
 

 
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For serial-use NPWT, measures of skin irritation and injuries 
and pain collected repeatedly after each drape change will be 
analyzed using linear mixed models to compare Comfort 
Release® drapes with the standard drapes. Fixed effects will 
include treatment group (intervention vs. control), time, an 
interaction between treatment group and time, gender, age, and 
other relevant patient comorbidities. Models will include a 
random effect of the patient id to controlfor the repeated 
measurements taken on patients over time. All hypothesis tests 
will be two-sided and p-values <0.05 will be considered 
statistically significant. Model assumptions of normality and 
homogenous variance will be assessed visually using plots of 
the model residuals. 
 
In Aim 2 (serial-use NPWT) the methodology is to demonstrate 
that compared to the standard NPWT drapes, patients with 
Comfort Release® drapes have statistically significant 
(α=0.05):1) decreased medical adhesive-related skin irritation 
and injuries, as measured by the MARSI scoring system, 16 2) 
lower experience of pain, as measured by the Indiana Polyclinic 
Combined Pain Scale, 3) improved compliance to the full 
duration of treatmentas prescribed by clinician, 4) decreased 
use of medication for pain and stress related to dressing 
removal, 5) demonstrate equivalent or better effectiveness in 
maintaining seal compared to control (leak incidence rate), 6) 
demonstrate clinician acceptability (questionnaire score >4) 7) 
demonstrate the ability of Comfort Release® drape to reduce 
nursing time by at least 20% compared to the standard drape; 
and 8) demonstrate significant time added economic value 
compared to the standard drape through economic analysis. 
 
 
4.2.2.1.3 IMPUTATION METHOD WHEN HANDLING 
MISSING DATA IN THE PRIMARY ANALYSIS 
Imputation is the process of replacing the missing date with 
estimated value based on other available information. Instead of 
deleting any patient that has missing information, the current 
study approach preserves all cases by replacing the missing data 
with a probable value estimated by other available information 
on the same patient with other drape changes. This will allow 
each patient’s data to be analyzed using standard statistical 
techniques. 
 
 
4.2.2.1.4 JUSTIFICATION OF ZERO SUPERIORITY MARGIN 
The aim of demonstrating superiority of the Comfort Release® 
drape showing that the product is ‘superior’ to the current 

 
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standard treatment used in each facility. The data from these 
trials are assessed for statistical significance That is, do the data 
show a difference between the drapes. The Comfort Release® 
product can be shown to be superior if results are statistically 
significant. This does not necessarily mean that the findings 
have clinical relevance. Statistical significance is a 
mathematical confirmation that the sample size is adequate to 
sufficiently determine if the data shows that a visible effect 
exists within the sample. Superiority is shown statistically when 
the difference between the mean of the new treatment drape 
and the mean of the standard treatment drape is not equal to 
zero within a 95% two-sided confidence interval. The 
difference between their means are different statistically to a 
significance of 5% (p=0.05). 
  
4.2.3 ENROLLMENT 
Post-surgical patients (n=100) will be enrolled at Weill 
Cornell under PI. Dr. Robert Winchell, at Columbia 
Presbyterian hospital under Co-Investigator Dr. Jarrod 
Bogue, and at Absolute Medical Center under Co-
Investigator Dr. Daniel Careaga for single-use NPWT. 
Patients will be randomized to control (standard drape) or 
intervention (Comfort Release® drape). 
 
Chronic wound patients (n=100) will be enrolled at Weill Cornell 
Medical Center under Principal Investigator Dr. Robert Winchell and 
at Vital Medical Research under Co-Investigator Deeva Frankel, 
DPM, D.ABFAS. Patients will be randomized to control (standard 
drape) or intervention (Comfort Release® drape). 
 
4.2.4 STUDY DURATION 
Post-surgical patients (n=100) enrolled at Weill Cornell under 
PI. Dr. Robert Winchell, at Columbia Presbyterian hospital 
under co-investigator Dr. Jarrod Bogue, and at Absolute 
Medical Center under Co-Investigator Dr. Daniel Careaga will 
occur over one year with interim checkpoints every 3 months 
to evaluate technical process and enrollment. For the treatment 
to be effective, the applied NPWT must maintain a strong 
adhesive seal for the duration of the treatment (1-7days). 
 
Chronic wound patients (n=100) will be enrolled at Weill Cornell Medical Center under Principal 
Investigator Dr. Robert Winchell and at Vital Medical Research under Co- Investigator Deeva 
Frankel, DPM, D.ABFAS over one year.

 
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4.2.5 INCLUSION CRITERIA 
Inclusion of Individuals Across the Lifespan Adults of all age ranges 
will be included in this study. Children will not be included as 1) we 
would like to test our novel drape technology in adults first and 2) 
there are no pediatric or neonatal guidelines for negative pressure 
wound therapy. 
 
Inclusion of Women and Minorities 
Women and minorities will be represented in this study. We 
will make our best effort to recruit across all races and 
ethnicities and aim to have a study population that is 
representativeof the demographics of the United States, 
however actual study enrollment may be limited due to the 
available patients. 
 
Inclusion criteria for Aim 1 are: 
 
1. patient is 18 years or older, 
2. scheduled for non-emergency surgery, 
3. NPWT recommended by the treating physician;  
4. a plan of treatment using NPWT; 
5. access to standard NPWT drape  and NPWT kits;  
6. patient ability to communicate pain using a scale.  
7. If outpatient, participants must return to the treating clinic for all drape changes to be performed    
under the supervision of study-trained clinical professionals. 
 
Inclusion criteria for Aim 2 are: 
1. patient is 18 years or older, 
2. NPWT recommended by the treating physician;   
3. a plan of treatment using NPWT; 
4. access to standard NPWT drape  and NPWT kits;  
5. patient ability to communicate pain using a scale. 
6. If outpatient, participants must return to the clinic for all drape changes to be performed under the 
supervision of study-trained clinical professionals.  
   
4.2.6 EXCLUSION CRITERIA 
Exclusion criteria for Aim 1include: 
    1. known hypersensitivity to acrylic adhesives;   
    2. known hypersensitivity to isopropyl alcohol; 
    3. the patient is expected to be unconscious during the drape removal/change;  
    4. unable to give consent; and language barrier, unless an interpreter is readily available. 
 
Exclusion criteria for Aim 2 includes: 
1. known hypersensitivity to acrylic adhesives; 

 
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2. known hypersensitivity to isopropyl alcohol; 
    3. the patient is expected to be unconscious during multiple drape removals/ changes; 
    4. unable to give consent; 
5. and language barrier, unless interpreter is readily available. 
 
 
 
4.2.7 PRIOR AND CONCOMITANT THERAPY 
Any concomitant therapy that study patient might be 
receiving is allowed as determined by the treating 
physician. 
 
  
4.2.8 TREATMENT REGIMEN 
Negative pressure wound therapy as ordered by the patient’s treating physician. 
 
Control patients using the standard drape will use the 
facilities’ standard operating procedures for the standard 
drape application and removal.. 
 
Study patients receiving the alternateComfort Release® drape 
will have the following directions for use by the clinicians in 
the study: 
  
Application of the Comfort Release® drape: 
Step 1. Cut and place the drape to cover foam or dressing, with 
an additional 1"-2” overlap onto intact peri-wound skin. 
Maintain at least one edge with a portion of the blue #2 tab. 
 
Step 2. Remove layer #1 to expose the adhesive. Place the 
adhesive side down over wound dressing/foam pad and 
adjacent skin. Smooth the drape over the skin to prevent 
creasing. 
  
Step 3. Remove layer #2. Next; to remove the blue #3 handling 
tab(s), hold the drape side of the perforationsteady with one hand. 
Then use your other hand to pull and remove the blue tab #3 
along the perforation line. A small portion of the tab remains on 
the drape (to assist with drape removal). Pat down to assure a 
good seal. 
 
Step 4. Follow facilityprotocoland manufacturer’s directions to 
complete the application of the NPWT device 

 
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Removal of the Comfort Release® drape: 
 
Step 1 Lift and swipe under the residual drape tab with 
alcohol prep pads or alcohol swab sticks, until the drape lifts 
easily from the skin. Continue to wet the underside of the 
drape with alcohol, where adhesive meets the skin. 
 
Step 2 Use additional alcohol prep pads or alcohol swab 
sticks, as needed, to keep the underside edge of the drape 
wet, to release the drape from the skin. 
 
Step 3 Carefully remove all the foam/dressing pieces 
from the wound bed. Note the number of pieces 
removed per facility protocol. 
 
Step 4 Discard the used drape and foam/dressing pieces per facility protocol. 
  
4.2.9 POSTOPERATIVE REGIMEN 
 
The same care as is standard for NPWT. 
 
4.2.10 CASE REPORT FORMS 
 
See attachments for: 
•     Aim 1 Training Protocol Manual with Case Report Forms  
o Eligibility  
o Consent and  Demographics o Participant Consent Forms 
o Medical History with Allergies 
  o Medical History Additional Pages  
o Concomitant Medications  
o Initial Drape Application 
o Additional Drape Application  
o Drape 
Removal  
o Pain Assessment   
o Skin assessment 
o Drape Re-Application Directions and Questions (use only if more than one drape        
application is needed) 
o Early NPWT Discontinuation (Early Exit Questionnaire) 
 
•     Aim 2 Training Protocol Manual with Case Report Forms  
o Eligibility 
o Demographics & Medical History o Concomitant Medication Log 
  o Drape Application Directions and Questions  
               o Drape Removal Concomitant Medication Log  

 
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               o Drape Removal Directions and Questions 
                o Drape Removal Pain Assessment  
                o Drape Removal Skin Assessment 
 o Drape Re-Application Directions and Questions 
 o Early NPWT Discontinuation (Early Exit Questionnaire) 
 
4.3 RISK ANALYSIS 
 
Comfort Release® technology has been successfully commercialized in acute and advanced 
wound care products including bandages, tapes and dressings.  Prior to usage in this study, the 
Comfort Release® drape has undergone rigorous internal quality testing to ensure its utility for 
study applications. These tests were used to determine the optimal formulation of the switchable 
adhesive in the drape. For example, groups of volunteers have already worn the new Comfort 
Release® drape material and followed directions for successful removal (Data available, upon 
requested). 
 
In addition, in the unlikely event that product performance milestones are not met, we can modify 
our prototype by implementing a change in formulation of adhesive and polymer used in its 
manufacture; these decisions will be dependent on the observed issue. We 
have already engineered several adhesive formulations that could be easily implemented if a change 
is needed. Further, if our enrollment targets are not reached, we may need 
to extend the study length beyond the initial study end date of August 31, 2026, by an additional 6 
months. 
 
Risk of the Comfort Release Drape: 
Subjects may experience discomfort, pain, irritation, or skin 
injury with the use of the Comfort Release® drape. Subjects 
will not participate in this study if you have known 
sensitivity to acrylic adhesive on the skin. 
As with any NPWT drape on the market, the airtight seal 
on your NPWT may leak air even when the Comfort 
Release® drape is applied correctly. 
 
Risks of Rubbing Alcohol: 
Anyone with known sensitivity to rubbing alcohol on the 
skin should not participate in this study. 
Rubbing alcohol or our standard acrylic adhesives 
may irritate the skin of some individuals. 
 
Unknown Risks 
There may be other risks of taking part in this research 
study that we don't know about. Subjects will be told if we 
learn about other risks that can affect their participation in 
the study. 
 
 
 

 
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Discomfort with Questionnaires 
The exit questionnaire completed if subjects withdraw from 
the study can make them uncomfortable. Subjects do not 
need to answer any questions that they are not comfortable 
with. 
  
Privacy 
To protect subjects' confidentiality, all subjects’ data will 
be assigned numerical study identifiers or "codes." No 
identifiable information will be provided to GLOBAL 
BIOMEDICAL TECHNOLOGIES, LLC. Before subject 
data are shared, the study doctor and staff will replace any 
information that could directly identify a subject (such as 
name, address, and contact information) with a generic 
code which the sponsor cannot link to that subject's identity 
to protect the confidentiality of the data. 
 
4.4 DESCRIPTION OF DEVICE 
This Direct-to-Phase II project will advance an adhesive 
acrylic NPWT drape incorporating novel OGS resin with a 
pressure sensitive acrylic that releases from the skin with 
the addition of isopropyl or rubbing alcohol. This patented 
Comfort Release® drape is applied to intact skin 
surrounding the wound bed which is packed with a foam 
sponge or gauze. At removal, isopropyl alcohol is applied 
to the adhesive interface to intact skin. This painless 
adhesive technology exhibits high patient satisfaction and 
decreased clinical time in bandage and tape applications. 
This project will demonstrate a) the equivalence of 
performance; and b) the reduction of MARSI and pain of 
Comfort Release® NPWT drapes against the market 
leader, standard drape. 
 
4.5 MONITORING PLAN 
 
Our team comprises experienced wound care professionals 
and clinicians from multiple specialties at four clinical 
sites. This team is highly knowledgeable in the use of 
NPWT for chronic wound and post-surgical applications 
and is well-equipped to quickly recognize and address 
complications specifically related to NPWT. 
 
The monitoring plan prioritizes collecting data relevant to 
the study objectives. Adverse event (AE) monitoring will 

 
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focus on events occurring within 1 hour of device removal 
and deemed related to the removal procedure or the device 
itself. 
 
 
 
 
4.5.1 PRIMARY SAFETY ENDPOINTS 
 
The primary safety endpoints for this study are: 
 
•The occurrence of adverse events directly related to 
the removal of the device, recorded within 1 hour 
post-removal. 
• Adverse events will be assessed for severity and 
attribution (e.g., definite, probable, possible, 
unlikely, or unrelated). Only events classified as 
definite, probable, or possible within the specified 
timeframe will be included in the study's analysis. 
• This streamlined data collection process ensures 
the study focuses on device-specific safety 
outcomes while excluding unrelated events. 
 
4.5.2 DEFINITIONS 
Attribution: The determination of whether an AE is related to a medical treatment or 
procedure. 
ATTRIBUTION CATEGORIES DESCRIPTION 
       •     Definite: The adverse event is clearly related to the investigational agent  
       •     Probable: The adverse event is likely related to the investigational agent 
   •     Possible: The adverse event may be related to the investigational agent 
   •     Unlikely: The adverse event is doubtfully related to the investigational agent 
   •     Unrelated: The adverse event is clearly NOT related to the investigational agent  
   •     Adverse Event (AE): Any adverse experience that occurs within 1 hour of device 
removal and is deemed related to the device or procedure. 
 
Disability: A substantial disruption of a person’s ability to conduct normal life functions. 
 
Life-threatening Adverse Event: Any adverse device 
experience that places the patient or subject, in the view 
of the investigator, at immediate risk of death from the 
reaction as it occurred (i.e., it does not include a 
reaction that, had it occurred in a more severe form, 
might have caused death). 
 
Serious Adverse Event (SAE): Any adverse device 
experience, related to the research interventionthat 
results in any of the following outcomes: death, a life-
threatening 
adverse 
device 

 
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experience,inpatienthospitalizationorprolongationof 
existinghospitalization,any persistent or significant 
disability/incapacity, or a congenital anomaly/birth 
defect. Important medical events that may not result 
in death, be life-threatening, or require hospitalization 
may be considered a serious adverse device experience 
when, based upon appropriatemedical judgment, they 
may jeopardizethe patient or subject and may require 
medical or surgical intervention to prevent one of the 
outcomes listed in this definition. 
 
Unexpected Adverse Event: Any adverse device 
experience, the specificityor severity of which is not 
consistent with the current investigator brochure; or, 
if an investigator brochure is not required or available, 
the specificity or severity of which is not consistent with 
the risk 
information described in 
the general 
investigational plan or elsewhere in the current 
application, as amended. “Unexpected” as used in this 
definition refers to an adverse device experience that 
has not been previously observed (e.g., included in the 
investigator brochure) rather than from the perspective 
of such experience not being anticipated from the 
device. 
 
 
4.5.3 RECORDING OF ADVERSE EVENTS 
Only adverse events occurring within 1 hour of device 
removal and deemed related to the removal procedure or 
device will be recorded. Events unrelated to the device or 
study intervention will not be collected. Documentation will 
be based on patient testimonials and investigator evaluation. 
  
4.5.4 REPORTING OF SERIOUS ADVERSE EVENTS 
 
The following events, occurring within 1 hour of device 
removal and related to the procedure or device, will be 
reported: 
 
• Moderate and Severe Events – Events that are Unexpected and Possibly, Probably, or 
Definitely   Related/Associated with the device removal. 
• ALL Life Threatening or Disabling Events Related to Device Removal 
• ALL Fatal Events – When the event occurs within 1 hour of device removal and 
is related to the procedure or device. 
 
 
4.5.4.1 STUDY SPONSOR NOTIFICATION 

 
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BY INVESTIGATOR All adverse events will 
be recorded and sent to the Sponsor. 
 
4.5.4.2 IRB NOTIFICATION BY INVESTIGATOR 
Reports of all unexpected problems (UPs) (including 
follow-up information) must be submitted to the IRB 
within 7 days. 
 
 
4.5.5 UNBLINDING PROCEDURES 
 
This is an unblinded study both for both study patients and 
all healthcare professionals involved in the care of a study 
patient. 
  
4.5.6 STOPPING RULES 
 
NPWT is stopped by the patient’s treating clinician. 
 
The patient (in either group) has a known reaction or 
develops or experiences a hypersensitivity or allergic 
reaction to the acrylic adhesive in the drape or a reaction 
to common isopropyl alcohol (rubbing alcohol). 
 
4.5.7 INTERNAL DATA AND SAFETY MONITORING BOARD 
 
Internal data review and safety every 3 months: 
 
That compared to the standard NPWT drapes, patients with Comfort Release® drapes have 
statistically significant (α=0.05): 1) decreased medical adhesive-related skin irritation and 
injuries, as measured by the MARSI scoring system, 2) lower experience of pain, as measured by 
the Indiana Polyclinic Combined Pain Scale, 3) improved compliance to the fullduration of 
treatment as prescribed by clinician, 4) decreased use of medication for pain and stress related to 
dressing removal, 5) demonstrate equivalent or better effectiveness in maintaining seal compared 
to control (leak incidence rate), 6) demonstrate clinician acceptability (questionnaire score >4) 7) 
demonstrate the ability of Comfort Release® drape to reduce nursing time by at least 20% 
compared to the standard drape; and 8) demonstrate significant time added economic value 
compared to the standard drape through economic analysis. 
 
 
4.5.8 INDEPENDENT DATA AND SAFETY MONITORING BOARD 
 
Independent data review will be conducted every 3 months. 
 
That compared to the standard NPWT drapes, patients with Comfort Release® drapes have 
statistically significant (α=0.05): 1) decreased medical adhesive-related skin irritation and 
injuries, as measured by the MARSIscoring system, 2) lower experience of pain, as measured by 

 
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the Indiana Polyclinic Combined Pain Scale, 3) improved compliance to the full duration of 
treatment as prescribed by clinician, 4) decreased use of medication for pain and stress related to 
dressing removal, 5) demonstrate equivalent or better effectiveness in maintaining seal compared 
to control (leak incidence rate), 6) demonstrate clinician acceptability (questionnaire score >4) 7) 
demonstrate the ability of Comfort Release® drape to reduce nursing time by at least 20% 
compared to the standard drape; and 8) demonstrate significant time added economic value 
compared to the standard drape through economic analysis. 
  
5. MANUFACTURING INFORMATION 
Global Biomedical Technologies has already gained a 
presence in the adhesive acute and advanced wound care 
market, so a logical transition would be to develop Comfort 
Release® drapes for NPWT in specific medical markets for 
both post-surgical and chronic wound patient use. Global 
Biomedical Technologies has developed an adhesive 
acrylicNPWT drape that incorporates innovative ester 
oligomers, that releases painlessly from the skin via the 
application of isopropyl alcohol. The underlying 
technology is a pressure sensitive bioengineered medical 
adhesive made with oligo (glycerol sebacate) and 
polyacrylate. This painless adhesive technology, “Comfort 
Release®,” has been demonstrated to result in high patient 
satisfaction and decreased nursing time in bandage and tape 
applications.  Successful completion of this project is 
expected to yield the data needed to support a 510K FDA 
clearance.  Global Biomedical Technologies is FDA 
registered as a medical device manufacturer for both Class I 
and Class II devices. 
 
8. IRB INFORMATION 
 
This protocol was previously reviewed and approved by the 
Columbia University Irving Medical Center (CUIMC) Institutional 
Review Board. Oversight of the study is being transferred to 
Advarra IRB, which will serve as the single IRB of record for all 
participating sites. 
Each site will cede review to Advarra through executed reliance 
agreements. All study conduct, consent materials, and 
continuing reviews will follow Advarra’s policies and 
procedures in compliance with 45 CFR 46 and applicable FDA 
regulations. 
 
Advarra IRB is fully accredited by the Association for the 
Accreditation of Human Research Protection Programs 
(AAHRPP). 
IRB of Record: Advarra IRB 
 
All sites participating in this study will cede review to Advarra 
IRB under executed reliance agreements. Site investigators and 
study staff will follow Advarra-approved protocols, consent 

 
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forms, and continuing review requirements. 
 
 
 
 
9. NAME AND ADDRESS OF THE INVESTIGATIONAL INSTITUTION 
 
Advarra Institutional Review Board 
Address: 6100 Merriweather Drive, Suite 600, Columbia, MD 21044  
Phone: 410-884-2900 
Email: info@advarra.com  
Website: www.advarra.com 
  
10. FINANCIAL CLAIMS 
 
10.1 FUNDING SOURCE 
 
This project is funded by a Direct Phase II clinical study by the NIH. NIH Score: 20. 
 
 
10.2 CONFLICT OF INTEREST 
 
Dr. Yadong Wang faculty at Weill Cornell is listed 
consultants to the NIH grant and have minority 
ownership in Global Biomedical Technologies, LLC. 
He will be involved in the clinical study. 
 
 
10.3 SUBJECT STIPENDS OR PAYMENTS 
 
Participants will not receive monetary compensation for study 
participation. However, subjects enrolled at any of the sites may 
receive reimbursement of $25 per completed study visit to offset 
travel expenses. 
 
This reimbursement is intended solely to cover costs incurred by the 
participant (e.g., transportation) and does not constitute a payment for 
participation. No additional stipends, bonuses, or incentives will be 
provided at any site. 
 
 
11. ENVIRONMENTAL ASSESSMENT 
Per Device Advice on the CDRH Web site, 
http://www.fda.gov/cdrh/devadvice/ide/application.shtml, 
an environmental assessment as required under 21 CFR 
25.40 or a claim for categorical exclusion under 21 CFR 
25.30 or 25.34 is no longer required. 
 
 

 
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12. REFERENCES 
 
1. Technical Data Comparison: Peel and Breathability Testing. 
2. Wang Y, Ameer GA, Sheppard BJ, Langer R. A 
tough biodegradable elastomer. Nature 
Biotechnology 2002;20:60-6 
3. Sen CK, Gordillo GM, Roy S, Kirsner R, Lambert L, 
Hunt TK, Gottrup F, Gurtner GC, Longaker MT. 
Human skin wounds: a major and snowballing threat 
to public health and the economy. Wound Repair 
Regen. 2009 Nov-Dec;17(6):763-71. doi: 
10.1111/j.1524-475X.2009.00543.x. PMID: 
19903300; PMCID: PMC2810192. 
4. National Health Statistic Report, Number 102, February 28, 2017 
5. Apelqvist J, Willy C, Fagerdahl A‐M, etal. EWMA 
document: negative pressure wound therapy: 
overview, challenges, and perspectives. Journal of 
wound care 2017; 26:S1‐S154. 
6. Zaver V, Kankanalu P. Negative Pressure Wound 
Therapy. Stat Pearls. Treasure Island (FL): Stat 
Pearls Publishing Copyright© 2022, Stat Pearls 
Publishing LLC.; 2022 
7. Vuerstaek JD, Vainas T, Wuite J, Nelemans P, 
Neumann MH, Veraart JC. State‐ of‐the-
arttreatmentof chronic leg ulcers: a randomized 
controlled trial comparing vacuum‐assisted closure 
(VAC) with modern wound dressings. Journal of 
vascular surgery 2006; 44:1029‐37 
8. General Surgery. Standford Medicine, 
2021.at 
https://stanfordhealthcare.org/medical‐
clinics/surgery‐clinic/patient‐ 
resources/surgery‐statistics.html.) 
9. Rippon M, White R, Davies P. Skin adhesives and 
their role in wound dressings. WOUNDS UK 
2007;3:76. 
10. Yates S, McNicholL, Heinecke SB, Gray M. 
Embracing the concept, defining the practice, and 
changing the outcome. Journal of Wound, Ostomy 
and Continence Nursing 2017;44:13‐7. 
11. MARSI COA. Medical Adhesive Related Skin 
Injury (MARSI): Wounds UK Made Easy. 
12. Ghersi MM, Ricotti C, Nousari CH, Newman MI. 
Negative pressure dressing in the managementof 

 
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pyoderma gangrenosum ulcer. Archives of 
dermatology 2007; 143:1249‐51. 
13. Upton D, Andrews A. Pain and trauma in 
negative pressure wound therapy: a review. Int 
Wound J 2015; 12:100‐5 
14. Upton D, Solowiej K, Hender C, Woodyatt KY. 
Stress and pain associated with dressing change in 
patients with chronic wounds. J Wound Care 2012; 
21:53‐ 4,6,8passim. 
15. Robertson F, Wang Y, Rosing H. An oligomeric 
switch that rapidly decreases the peel strength of a 
pressure‐sensitive adhesive. International Journal of 
Adhesion and Adhesives 2014; 55:64‐8 
16. Skin‐Friendly Adhesives Show Their Sensitive Side. 
MDDI,2012. at 
https://www.mddionline.com/news/skin‐friendly‐
adhesives‐show‐their‐sensitive‐ side.) 
17. McNichol L, Lund C, Rosen T, Gray M. Medical adhesives and patient safety: 
 
state of the science: consensus statements for the 
assessment, prevention, and treatment of adhesive-
related skin injuries. Journal of Wound, Ostomy 
and Continence Nursing. 2013; 40(4):365-80. DOI: 
10.1097/WON.0b013e3182995516(British Journal 
of Nursing). 
18. Fumarola S, Allaway R, Callaghan R, et al. 
Overlooked and underestimated: medical adhesive-
related skin injuries. Journal of Wound Care. 2020; 
29(Sup3c). DOI: 10.12968/jowc.2020.29.Sup3c.S1. 
19. The Indiana Polyclinic Combined Pain Scale. 2022 
.at https://www.painscale.com/article/the‐indiana‐
polyclinic‐combined‐pain‐scale.) 
20. Blume PA, Walters J, Payne W, Ayala J, Lantis J. 
Comparison of negative pressure wound therapy using 
vacuum‐assisted closure with advanced moist wound 
therapy in the treatmentof diabeticfoot ulcers: a 
multicenter randomized controlled trial. Diabetes care 
2008;31:631‐6. 
21. Xu R, Xia H, He W,etal. Controlled water vapor 
transmission rate promotes wound‐healing via 
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22. 3M™ Dermatac™ Drape with V.A.C.® Granufoam™ Dressing Kit. 2022. (Accessed     
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13. ATTACHMENTS 
•     Efficacy of Comfort Release Sacral 
Bordered Foam Dressings, 2023  
•     Prototype drape testing (S-2747) 
•     GB141-A IFU 
•     Aim 1 Case Report Forms  
o Eligibility Criteria 
o Consent and Demographics 
o Medical History with Allergies  
o Medical History Additional Pages  
o Concomitant Medication Log 
o Initial Drape Application  
o Drape Removal Concomitant  Medication Log   
o Drape Removal  
o Pain Assessment  
o Skin Assessment 
o Drape Re-Application   
o Early Exit Questionnaire   
      •     Aim 2 Case Report Forms 
o Eligibility Criteria 
o Consent and Demographics 
o Medical History with Allergies 
o Medical History Additional Pages  
o Concomitant Medication Log 
o Initial Drape Application   
o Drape Removal Concomitant Medication Log  
o Drape Removal 
o Pain Assessment  
o Skin Assessment 
o Drape Re-Application 
o Early Exit Questionnaire