Adhesive Tape Trauma Evaluation of a New Gentle Tape in Healthy Infant Subjects
Phase: NA
Conditions: Skin (FLACC Scores of Test Subjects) After Tape Removal
Sponsor: Solventum US LLC

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Clinical Study Protocol
Based on the International Conference on Harmonization
Good Clinical Practice
Consolidated Guideline
Federal Register: Docket No. 95D-0219
62 FR 25692/May 9, 1997 
Also Presented as
Guidance for Industry
E6 Good Clinical Practice:
Consolidated Guidance
U.S. Department of Health and Human Services
Food and Drug Administration 
Center for Drug Evaluation and Research (CDER)
Center for Biological Evaluation and Research (CBER)
April 1996
ICH

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Clinical Study Protocol
Study Number and Protocol Title
Study 05-014050
 
 Tape in Healthy Infant Subjects
Principal Investigator
Sub-investigator (if applicable)
Research Facility
Gary Grove, PhD
Charles Zerweck, PhD
Danielle Fendrick (Vice President of Operations)
cyberDERM, Inc.
867 Sussex Blvd.
Broomall, PA 19008
Telephone: 610-325-0112
Fax: 610-325-0881
E-mail: dfendrick@cyberderm-inc.com
IRB
Allendale Investigational Review Board
30 Neck Road, Old Lyme, CT 06371
Sponsor
3M Health Care
Health Care Business Group
3M Center, Bldg 270-3A-04
St. Paul, MN  55144-1000
3M Study Monitor
Joseph A. Tucker
3M Health Care
Health Care Business Group
3M Center, Bldg 270-3A-04
St. Paul, MN  55144-1000
Telephone: 651-736-4685
                   651-335-5883 (cell)
Fax: 651-733-4931
E-mail: jatucker@mmm.com
3M Medical Monitor (if applicable)
Patrick J. Parks, MD, PhD
3M Health Care
Critical & Chronic Care Solutions Division
3M Center, Bldg 270-3A-04
St. Paul, MN  55144-1000
Telephone: 651-736-4868
                   651-334-6225 (cell)
E-mail: pjparks@mmm.com
3M Confidential
This document contains confidential information that is the property of 3M and is subject to all of 
the restrictions on use and disclosure contained in the study contract to which this is appended. 
Do not copy, disclose, circulate or use for benefit for any third party without written authorization 
from 3M.

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Approver List (3M Approvers Only):
Signer
Role
Date Signed
us342303:Smith Graham E
Clinical
December 11, 2017 09:44:47 AM CST
US291440:Parks Patrick J
Clinical
December 09, 2017 09:14:32 AM CST
A7SGSZZ:Swearingen Anne
Clinical
December 11, 2017 09:13:56 AM CST
us231932:Tucker Joseph A
Clinical
December 08, 2017 06:10:13 PM CST
cc:  
Clinical Study Folder
Investigator Study Documentation File (Regulatory Binder)

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TABLE OF CONTENTS
1.0
STATEMENT OF COMPLIANCE ....................................................................................................6
2.0
BACKGROUND INFORMATION.....................................................................................................7
2.1 Name, Description and Intended Use of the Investigational Material ............................7
2.2 Summary of Previous Studies .......................................................................................7
2.3 Risk/Benefit Summary..................................................................................................7
2.4 Investigational Material Application.............................................................................8
2.5 GCP and Regulatory Requirements...............................................................................8
2.6 Study Population ..........................................................................................................8
3.0
STUDY OBJECTIVES AND PURPOSE...........................................................................................8
4.0
STUDY DESIGN..............................................................................................................................8
4.1 Study Type ...................................................................................................................8
4.2 Primary and Secondary Endpoints ................................................................................8
4.3 Randomization and Blinding.........................................................................................9
4.4 Study Materials and Labeling .......................................................................................9
4.4.1
Investigational Material Labeling.............................................................................9
4.4.2
Other Materials Used in this Study..........................................................................9
4.5 Study Duration .............................................................................................................9
4.6 Study Termination/Subject Discontinuation or Withdrawal/Subject Revocation of 
Authorization..............................................................................................................10
4.6.1
Study Termination.................................................................................................. 10
4.6.2
Subject Discontinuation.........................................................................................10
4.6.3
Subject Revocation of Authorization to Use and Disclose PHI............................10
4.7 Investigational Material Accountability ......................................................................10
4.8 Source Data................................................................................................................11
4.9 Protocol Modifications ...............................................................................................11
4.9.1
Protocol Amendments ...........................................................................................11
4.9.2
Protocol Deviations................................................................................................11
4.10 Computerized Systems ...............................................................................................11
5.0
SUBJECT SELECTION.................................................................................................................12
5.1 Subject Inclusion Criteria ...........................................................................................12
5.2 Subject Exclusion Criteria ..........................................................................................12
5.3 Subject Assent and Parent Consent .............................................................................12
5.4 Subject Authorization for Use and Disclosure of Protected Health Information (PHI).13
6.0
TREATMENT OF SUBJECTS....................................................................................................... 13
6.1 Treatment(s) to be administered..................................................................................13
6.1.1
Screening Visit (Day -7 to -2) .................................................................................13
6.1.2
Washout (Day -1).................................................................................................... 13
6.1.3
Tape Application (T0).............................................................................................13
6.1.4
Tape Removal (T24)................................................................................................14
7.0
ASSESSMENT OF EFFICACY...................................................................................................... 14

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7.1 Efficacy Parameters....................................................................................................14
7.1.1
Tape Lift..................................................................................................................14
7.1.2
Faces, Legs, Activity, Cry and Consolability (FLACC) Behavioral Pain 
Assessment.........................................................................................................................14
7.1.3
Skin Erythema and Skin Stripping.........................................................................15
7.1.4
Hair and Skin Cell Quantification...........................................................................15
7.2 Assessment Methods ..................................................................................................15
7.2.1
Lift Assessment...................................................................................................... 15
7.2.2
Discomfort Assessment.........................................................................................15
7.2.3
Laboratory Assessments.......................................................................................15
7.2.4
Expert Skin Grader Assessments..........................................................................15
7.2.5
Photography...........................................................................................................16
8.0
ASSESSMENT OF SAFETY .........................................................................................................16
8.1 Safety Parameters .......................................................................................................16
8.2 Anticipated Events......................................................................................................16
8.3 Adverse Events...........................................................................................................17
9.0
STATISTICS ................................................................................................................................. 18
9.1 Data Sets Analyzed.....................................................................................................18
9.2 Statistical Methods .....................................................................................................18
9.2.1
Efficacy Analyses................................................................................................... 18
9.2.2
Safety Analyses...................................................................................................... 18
9.3 Sample Size Justification ............................................................................................18
9.4 Procedures for Accounting for Missing, Unused, and Spurious Data...........................18
9.5 Deviations to Statistical Plan ......................................................................................18
10.0 MONITORING...............................................................................................................................19
11.0 QUALITY CONTROL AND QUALITY ASSURANCE..................................................................... 19
12.0 ETHICS.........................................................................................................................................19
12.1 Confidentiality............................................................................................................19
13.0 DATA HANDLING AND RECORD KEEPING................................................................................20
13.1 Study Personnel..........................................................................................................20
13.2 Pre-Study Documentation Requirements.....................................................................20
13.3 Completion and Return of Case Report Forms............................................................20
13.4 Final Report................................................................................................................20
13.5 Records, Reports and Retention Requirements............................................................21
14.0 REFERENCES..............................................................................................................................21

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1.0 Statement of Compliance
This study, “
 in Healthy Infant Subjects,”
will be carried out in accordance with Good Clinical Practice (GCP) as required by the following:
!
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 
46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812)
!
ICH GCP E6.
Any and all individuals responsible for the design and conduct of this trial have completed Human 
Subjects Protection Training.
I agree to ensure that all staff members involved in the conduct of this study are informed about their 
obligations in meeting the above commitments.
Principal Investigator: ___________________________
Print/Type name
Signed: ________________________________________ Date: ________________________
Signature

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2.0 Background Information
2.1
Name, Description and Intended Use of the Investigational Material
 
 The adhesive is intended for contact with intact 
skin for a prolonged period.
The tape is supplied non-sterile in multiple sizes and lengths. The tape does not contain any 
medicinal substances, biological tissues, or blood products.
is a general purpose medical adhesive tape for medical applications used primarily to 
secure dressings, lightweight tubing, and devices to skin.
2.2
Summary of Previous Studies
The studies completed to assess the biocompatibility of 
were selected based on the 
international standard ISO 10993-1: 2003 (E), Biological Evaluation of Medical Devices Part 
1: Evaluation and Testing.
is categorized as a surface device having prolonged contact (24 hours to 30 days) on 
intact skin.  Tests included Cytotoxicity by MEM Elution and Agar Overlay methods per ISO 
10993-5; Primary skin irritation in rabbits (24 hour contact time) per ISO 10993-10; and a 
Guinea Pig Maximization test using saline and sesame oil extracts of the tape per ISO 
10993-10.  In addition, a Human Repeat Insult Patch Test (HRIPT) was conducted (n=212) 
on the tape.  The tape was determined to be non-cytotoxic, non-irritating, and non-sensitizing.
A toxicology risk assessment of the materials used in
has been completed by 3M 
Toxicology & Compliance Solutions, 3M Medical Department, and all materials are 
considered safe for human use.
During the development of
, a total of 21 clinical studies have been conducted on 
various, but similar, formulations of the product and there have been no adverse events 
noted on 
.  There have been a total of 272 healthy adult volunteers in these trials. A 
number of healthy adult volunteers may have participated in more than one 3M internal 
clinical study. To date there have not been any studies conducted on healthy infants or 
children.
2.3
Risk/Benefit Summary
Tapes are considered to be low risk medical devices that are commonly used throughout 
healthcare and in home use, and on patients of various ages, with few problems. Potential 
risks to the subject include possible itch, slight discomfort during removal, erythema, and skin 
stripping, typically without any long-term effects. No subject is expected to endure more than 
slight discomfort upon removal of the tape. There are no medical benefits for a subject who 
participates in this study.

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2.4
Investigational Material Application
The product to be tested is an investigational adhesive tape for medical use and will be used 
as intended. There will be no control tape for this study. Tape will be provided in 1-inch wide 
widths and will be applied as 1-inch by 1.5-inch strips onto the back of the subject.  The tape
will be allowed to remain in place for approximately 24 hours before removal. The tape will 
be applied and removed according to the procedures listed in Appendix 1.
2.5
GCP and Regulatory Requirements
3M does not consider 
 to be a significant risk investigational device.  This study will be 
conducted in compliance with this protocol, GCP, and applicable state and federal 
regulations, including 45 CFR 160 & 164 (Authorization for Use/Disclosure of PHI), 21 CFR 
812.2 [b] (Investigational Device Exemptions-Abbreviated Requirements), and 50 (Informed 
Consent).
2.6
Study Population
Up to 24 subjects that meet the inclusion/exclusion criteria will be enrolled in the study.  
During recruitment, an attempt will be made to balance the genders as much as possible.
Any subjects that withdraw or are withdrawn from the study may be replaced to ensure that a 
total of 20 subjects complete the study.  (Up to 24 total subjects are anticipated to be 
screened and potentially enrolled in the study to reach a final enrollment target of 20 
subjects.) Subjects will be healthy infant volunteers of either gender, between the ages of 6 
months and 4 years of age, and free of skin problems on the intrascapular region of the back.
Refer to Inclusion/Exclusion criteria listed in Section 4.0 for more detail.
3.0
Study Objectives and Purpose
The objective of this study is to determine the relative
.  A three-prong 
multidimensional evaluation consisting of expert grader, subject discomfort assessment, and 
laboratory assessments will be used.  One pre-study visit will take place up to 7 days prior to the 
start of the study. The study will be conducted over two days with one tape sample applied and 
removed.  Assessments will be taken on the final day. This is to mimic a normal tape application in 
health care practice.  Assessments will be compared to those taken in a previous study.
4.0
Study Design
4.1
Study Type
This will be a prospective study with a multidimensional evaluation, consisting of skin 
assessments made by an expert skin grader, subject discomfort assessments performed by 
an expert discomfort grader, and laboratory assessments (hair and skin cell quantification) on 
the removed tapes.
4.2
Primary and Secondary Endpoints
The primary endpoint will be the change in the subject discomfort (from baseline to the final 
assessment) using the FLACC (face, legs, activity, cry, consolability) scale.

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Secondary endpoints will be laboratory assessments (hair and skin cell quantification), skin 
erythema (as made by an expert skin grader), skin denudation (skin stripping), and sample 
lift.
These endpoints will be compared to those taken in a previous study.
4.3
Randomization and Blinding
There will be no randomization used in this study, as only 1 test sample will be evaluated.
The discomfort assessor will be observing the video recording of the subject’s full anterior 
side.
4.4
Study Materials and Labeling
Investigational Material: 
, provided in 1-
inch wide rolls.
4.4.1
Investigational Material Labeling
3M will label, package and ship the study tape to the research facility. Rolls of tape will be 
provided in bulk. Each investigational material bulk package will be labeled with the following 
minimum information:
!
Study Number  05-014050
!
3M Health Care Business Group, St. Paul, MN 55144-1000
!
Identifying lot
!
Quantity of contents
!
For use in study 05-014050 only.
!
“Use as directed in protocol”
4.4.2
Other Materials Used in this Study
!
Sterile Petri Dishes
!
Digital SLR camera (provided by the study investigator)
!
Digital Video camera (provided by study investigator)
4.5
Study Duration
The duration of each study subject’s participation will be up to 9 days (3 visits), consisting of 
1 day for subject screening, including acclimation to study staff and facility, and 2 days for 
material application and removal.

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4.6
Study Termination/Subject Discontinuation or Withdrawal/Subject Revocation of 
Authorization
4.6.1
Study Termination
3M or the Investigator has the right to discontinue the study at any time for medical 
and/or administrative reasons.  As far as possible, this should occur after mutual 
consultation.
4.6.2
Subject Discontinuation
The Investigator may discontinue individual subjects from the study at any time.  
Subjects may voluntarily withdraw from the study at any time.  The Investigator will 
provide a written report on the appropriate CRF describing the reason for 
discontinuance and the date of discontinuance.
A subject who discontinues may be replaced with another qualified subject who will 
follow the same treatment scheme as the discontinued subject in order to finish with 
a minimum of 20 subjects.
4.6.3
Subject Revocation of Authorization to Use and Disclose PHI
In order to implement a valid revocation of authorization, the subject’s parent or legal 
representative must make the request in writing to cyberDERM, inc., 867 Sussex 
Blvd., Broomall, PA 19008.  The revocation cannot stop the use or disclosure of 
information that has been collected prior to the revocation, which is needed to ensure 
complete and accurate study results and is required by law or government regulation 
(e.g. reporting adverse events, etc.).  Revocation of an authorization may not be used 
to withhold normal medical care from the subject but may make the subject ineligible 
to receive the study treatment or care.
4.7
Investigational Material Accountability
3M requires Investigators to maintain accountability and adequate inventory security 
of the investigational material at all times. The Investigator or designee will:
!
Complete a Confirmation of Release and Receipt of Clinical Supplies form 
and maintain and account for inventory on the Investigational Material 
Disposition form.
!
Keep investigational materials in a secure storage area, accessible only to 
authorized individuals.
!
Dispense investigational material only to subjects properly enrolled into the 
study.
!
Return all unused investigational materials to 3M at the end of the study, or 
dispose of as agreed upon.

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4.8
Source Data 
Source data includes any original documents, data, and records where any study data is first 
recorded (e.g., hospital records, patient charts, laboratory notes, questionnaires, 
photographs, and consent forms).
For this study, paper case report forms (CRFs) will be provided by cyberDERM for each 
subject.  All required data will be recorded in the CRFs.  If study-related data are recorded for 
the first time directly into the CRF, then the CRF is the source document.  Completed CRFs 
will be reviewed by the site monitor to ensure accuracy and consistency of subject data.
Any discrepancies found during CRF review are to be clarified by the Investigator or 
designee.
4.9
Protocol Modifications
4.9.1
Protocol Amendments
The party initiating an amendment must confirm it clearly in writing using the 
Amendment/Administrative Revision form.  It must be signed and dated by 3M, and, 
in the case of a significant amendment, the Investigator.  A significant amendment 
means one that affects the safety, rights or welfare of subjects, the scope of the 
investigation or the scientific quality of the study.
3M will submit protocol amendments to the Investigator for submission to the IRB for 
pre-approval.  3M will also notify the Investigator when a protocol amendment may 
be implemented (post IRB approval).
4.9.2
Protocol Deviations
A deviation is a departure from the protocol.
A protocol deviation is only for an individual subject.  Protocol deviations are 
documented on a Protocol Deviation CRF.
Deviations that potentially affect 1) subject safety, rights or welfare, 2) data integrity 
or 3) compromise the statistical analysis of the study require immediate 
communication to 3M; the Investigator must contact the 3M study monitor within 24 
hours of occurrence (651-736-4685).  A Protocol Deviation Form must be completed 
by the Investigator and include the type of deviation and a description of the 
circumstances surrounding the deviation.
Deviations which are made to protect the life or physical well-being of a subject in an 
emergency must be reported to the IRB within 24 hours after the Investigator learns 
of the occurrence.
4.10 Computerized Systems
The computer software systems that will be used to create, modify, maintain, archive, 
retrieve, or transmit data will be:  eMatrix, SAS, Excel, Word, Outlook, and Minitab.
Electronic study documents will be stored in eMatrix.

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5.0
Subject Selection
5.1
Subject Inclusion Criteria
Subjects will be infants or children of either gender who meet the following criteria:
1. Who are healthy and who have intact skin at the test site with a baseline score of 0 for 
erythema
2. Who are between the ages of 6 months – 4 years of age (48 months)
3. Who have a Fitzpatrick Skin Type of I, II or III
4. Whose parent or legal representative agrees to not use any products (i.e. topical 
medications, creams, powders or ointments) on the test sites for 24 hours prior to the 
study start date
5. Whose parent or legal representative agrees to sponge bathe their child during the 
study but agrees to not bathe their child 1 hour before each visit.
6. Whose parent or legal representative agrees to not soak the tape during a sponge 
bath.  If the site gets wet, parent or legal representative agrees to pat their child’s back 
dry (no rubbing).
7. Whose parent or legal representative is willing to sign the Informed Consent Form (with 
photo release) and HIPAA Authorization.
5.2
Subject Exclusion Criteria
Subjects who are specifically excluded from this study are subjects:
1. Who are known to be developmentally delayed
2. Who have any known allergy or sensitivity to tapes
3. Who have sunburn, skin infection or scars, moles, or other blemishes on the back that 
would obscure grading of the test site
4. Who have had any exposure to other topical medications, creams, powders, or 
ointments on the test sites 24 hours prior to the start of the study
5. Who have had a strep infection within the 2 weeks prior to the start of the study
6. Who have a history of uncontrolled diabetes, psoriasis, any active dermatitis, or recent 
history of dermatitis or skin reactions
7. Has participated in any study in the last 2 weeks, or are currently participating in 
another study, or are scheduled to participate in another study during this study period.
8. Has any other skin disorders that, in the opinion of the investigator, will interfere with 
the study results or will increase undue risk for the child.
5.3
Subject Assent and Parent Consent
Active written assent will not be obtained because the subjects are not of the appropriate 
intellectual age (i.e., typically 7 years of age and older).
The Investigator must ensure that written informed consent to participate in the investigation is 
obtained before including any individual as a subject in the investigation.  The Investigator 
must provide the prospective subject’s parent or legal representative sufficient opportunity to 
consider whether or not to participate, and minimize the possibility of coercion or undue 
influence. The process is designed to 1) give the subject’s parent or legal representative all 
the information that they need, 2) ensure that the subject’s parent or legal representative 
understands the information and 3) give the subject’s parent or legal representative a chance 
to consider study participation.  The process should permit the subject’s parent or legal 
representative to ask questions and exchange information freely.

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Specifically, the Investigator is to explain to each subject’s parent or legal representative all 
elements of informed consent (as specified in 21 CFR 50.25 [Appendix 11.1]).  After the 
explanation, the parent or legal representative will voluntarily sign and date the consent form if 
they wish their child to participate in the study.  A copy of the consent form must be provided 
to the parent or legal representative.  A signed and dated copy of the consent form must be 
maintained in the Investigator study documentation file at all times.
5.4
Subject Authorization for Use and Disclosure of Protected Health Information (PHI)
The Investigator must ensure that written authorization for use and disclosure of protected 
health information is obtained before including any individual as a subject in the investigation.
Specifically, the Investigator is to explain to each subject’s parent or legal representative all 
elements of authorization as specified in 45 CFR 164.508.  After the explanation, the parent
or legal representative must voluntarily sign and date the authorization form if they wish their 
child to participate in the study.  A copy of the authorization form must be provided to the 
parent or legal representative.  A signed and dated copy of the authorization form must be 
maintained in the Investigator study documentation file at all times and may be placed in the 
subject’s medical record.
An authorization form may be combined with a consent form (i.e. compound authorization) if 
required by the IRB.  All required elements for both informed consent and authorization must 
be included in a compound authorization.
6.0
Treatment of Subjects
See Appendix 1 (Study Schedule) for listing of procedures and assessments.
6.1
Treatment(s) to be administered
6.1.1
Screening Visit (Day -7 to -2)
!
Review Inclusion/Exclusion Criteria
!
Obtain parent/legal representative consent
!
Obtain HIPAA authorization
!
Obtain relevant infant medical history
!
Acclimate subject to study staff and facility
6.1.2
Washout (Day -1)
!
Remind parent or legal representative to refrain from applying topical medications, 
creams, powders, ointments, etc. on test site area of the subject.
6.1.3
Tape Application (T0)
!
Review Inclusion/Exclusion Criteria.  Ensure that subjects have not exposed their 
skin to topical medications, creams, powders, or ointments on the test sites.
!
Verify that the subject has intact skin at the test sites with no visible erythema.

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!
Outline and label 1 site on the child’s back, between the shoulder blades using a 
non-toxic permanent skin marking pen.  The site on the back will be 1 inch by 1.5 
inches in size.  The site will be remarked on Day 2 if needed.
!
Perform Expert Grader baseline assessments for erythema.
!
Apply investigational tape to intrascapular region with gloved hands. The child may 
be seated on the parent’s or legal representative’s lap during sample application for 
ease of application.  Allow to dwell for approximately 24 hours.
6.1.4
Tape Removal (T24)
!
Before tape is removed, assess tape lift at the test site.  Re-mark test site with non-
toxic permanent skin marking pen if needed.
!
Begin filming subject when subject is relaxed and record for approximately 2 minutes 
prior to removal of the tape.  Include at start of video a card indicating screening 
number and subject number. 
!
Remove tape with gloved hands (continue filming). Collect the tape sample in a Petri 
dish. Continue filming approximately 2 minutes after tape removal.  Include at 
completion of video a card indicating screening number and subject number.  Subject 
discomfort assessment will be rated externally.
!
Take photos and perform Expert Skin Grader assessment for erythema and skin 
stripping approximately 30 minutes post-removal of tape.
!
Tape samples shipped to study sponsor for further laboratory analysis.
7.0
Assessment of Efficacy
7.1
Efficacy Parameters
The following efficacy parameters will be computed for each subject:
7.1.1
Tape Lift
!
Measured prior to tape removal at T24 by an expert grader.
7.1.2
Faces, Legs, Activity, Cry and Consolability (FLACC) Behavioral Pain Assessment
!
At T24, just prior to tape removal (for approximately 2 minutes), and following tape 
removal (for approximately 2 minutes), the subject will be videotaped to document 
their reaction at baseline, upon removal, and after removal of the tape.
!
Video recordings will be sent to the 3M, where the subject’s reaction will be scored by 
a discomfort expert (identified by 3M), using the Faces, Legs, Activity, Cry and 
Consolability (FLACC) Behavioral Pain Assessment. The discomfort expert will be 
blinded as to whether the video is from baseline or the removal of the tape.
!
Video recordings will be made of the subject’s full anterior side.  The removal of the 
tape will be completed only when the infant appears to be relaxed (not anxious or 
stressed).

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7.1.3
Skin Erythema and Skin Stripping
!
Measured approximately 30 minutes after tape removal on Day 2 by an expert skin 
grader.
7.1.4
Hair and Skin Cell Quantification
!
Measured by established techniques in 3M laboratories.
7.2
Assessment Methods
7.2.1
Lift Assessment
Lift Assessment will be taken prior to removal at T24. Lift will be assessed according 
to the following scale:
0 = No lift
0.5 = Corner lift only (up to four corners)
1 = 1-25% lift
2 = 26-50% lift
3 = 51-75% lift
4 = 76-99% lift
5 = Tape is missing
7.2.2
Discomfort Assessment
At T24, just prior to tape removal (for approximately 2 minutes), and following tape 
removal (for approximately 2 minutes), the subject will be videotaped to document 
their reaction at baseline, upon removal, and after removal of the tape.  The video 
recordings will be sent to the 3M, where the subject’s reaction will be scored by a 
discomfort expert (identified by 3M) using the Faces, Legs, Activity, Cry and 
Consolability (FLACC) Behavioral Pain Assessment.  Video recordings will be made 
of the subject’s full anterior side.  The removal of the tape will be completed only 
when the infant appears to be relaxed (not anxious or stressed).
7.2.3
Laboratory Assessments
The tape sample that has been removed from each subject with gloved hands will be 
placed in a Petri dish and shipped to 3M for further laboratory testing, including 
quantifying the amount of hair and skin cells removed by the tape samples.  Hair 
counts will be completed on each tape specimen.  The skin cells will be quantified 
using bicinchoninic acid (BCA) colorimetric detection and protein quantification on the 
same tape samples. The samples will be identified by screening number and subject 
number. If samples fell off during the 24 hour wear, the samples will not be retrieved.
7.2.4
Expert Skin Grader Assessments
At T0 (Baseline), Expert Skin Grader Assessments of Erythema will be made prior to 
the first tape application.  At T24, Expert Skin Grader Assessments will be made 
approximately 30 minutes after the tape is removed. If the sample is missing at T24, 
no assessment will be conducted.

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3.2.1.1 Erythema & Edema Visual Assessment Method
Score
Description of Response
0
No visible response
1
Mild Response. Diffused, patchy, not well-defined, just barely
perceived erythema. No perceivable edema.
2
Moderate Response. Perceivable erythema is obvious, with diffused
redness. Pink or red in color, area well defined. No edema.
3
Severe Response. Obvious erythema. Definite red in color, area 
well defined. Edema Present.
4
Extreme Response. Bright, fiery red erythema. Edema is present.
3.2.1.2 Skin stripping (Denudation) Scale
Score
3M Denudation Severity Scale
0
No sign of denudation.
1
Trace amount of denudations in epidermis. (Slight glazed 
appearance).
2
Partial thickness denudations (first sign of pitting in the skin) extending 
up to the glistening layer of the epidermis. (Moist and/or wet 
surface).
3
Full thickness denudations extending into the dermis. (Exudates 
present on the test site)
4
Full thickness denudations extending into the dermis or in combination 
with an extreme Erythema/Edema response.
Erythema with edema will be assessed at T0 and T24.  Skin stripping will be 
assessed at T24.
7.2.5
Photography
Photographs will be taken at T24 to document skin reactions. The photographs may 
be used in publications to visually document the erythema scores determined by the 
Expert Skin Grader.
8.0
Assessment of Safety
8.1
Safety Parameters
The principle measure of safety will be the incidence of tape-related adverse events reported 
during the study.
8.2
Anticipated Events
For the purpose of this study, any signs or symptoms of expected events associated with the 
tape application/removal including erythema, skin stripping, itching and discomfort upon 
removal may or may not be coded as an adverse event based on the investigator assessment.  

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If any of these irritation parameters appear to be highly exacerbated, more than normally 
associated with use conditions in this type of population, the event will be recorded as an 
adverse event.  This can only be determined by the investigator.
8.3
Adverse Events 
The Investigator is responsible for identifying adverse events that occur to each subject 
throughout the study and follow-up period.  An adverse event can occur at any time during the 
conduct of the study, in any phase of the study or after the study is completed. An adverse 
event can be identified by the Investigator or reported by the subject.
For this study, any non-device adverse events (e.g. common cold, falls, systemic 
illnesses, etc.) will not be recorded.  All device-related and serious adverse events will need 
to be reported to the sponsor.
Note: The Federal Privacy Rule (HIPAA) specifically permits the use and disclosure of 
protected health information “without written authorization of the individual” when used for 
public health activities such as reporting adverse events, tracking FDA-related products, 
enabling recalls, repairs, replacements, lookbacks, or conducting post-market surveillance [45 
CFR 164.512].  This use and disclosure is subject to the minimum necessary standard, i.e. 
“the minimum necessary to accomplish the intended use, disclosure, or request” [45 CFR 
164.502(b)(1)].
Definitions:
!
Adverse event (AE) means any undesirable clinical occurrence in a subject whether or 
not it is considered to be device related.
!
Device-related adverse event (i.e. adverse device effect) is an AE considered by the 
Investigator to have a reasonable likelihood of being associated with the 
investigational device.
!
Serious adverse device effect is a device effect that has a serious adverse effect on 
health or safety causing hospitalization or prolonged hospitalization, or is life 
threatening or causes death.
!
Unanticipated adverse device effect is any serious adverse device effect on health or 
safety or any life-threatening problem or death caused by, or associated with a device 
if that effect, problem or death was not previously identified in nature, severity or 
degree of incidence in the investigational plan or application, or any other 
unanticipated serious problem associated with a device that relates to rights, safety 
and welfare of subjects.
Recording and Reporting
The Investigator records each material-related adverse event on an Adverse Event CRF. 
Documentation includes the description, severity, seriousness, date of onset and resolution, 
relationship to the investigational material, action taken and outcome.
The Investigator must promptly report an adverse device effect to the 3M study monitor.  If the 
adverse device effect is also considered by the Investigator to be serious and/or unanticipated, 
the Investigator must report it to the IRB as soon as possible and within IRB requirements.

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A serious AE involving a non-3M commercialized product is reported to the 3M study monitor 
and IRB.
If a subject has no adverse device effect during the study, the absence of such must be 
recorded on the CRF.
9.0 Statistics
9.1
Data Sets Analyzed
Data obtained for all subjects that enter the study and have samples applied will be analyzed 
in this study.
9.2
Statistical Methods
9.2.1
Efficacy Analyses
The BCA results will be summarized, and log-transformed data will be compared to a 
previous study.
Cumulative FLACC scores will be calculated from this study and compared to a 
previous study.
Summary statistics will be provided for all variables tested in the study. This includes 
tables with mean, median, std dev, min, and max, as well as frequency distribution 
tables when needed.
9.2.2
Safety Analyses
The analyses listed above for erythema, denudation, and discomfort will be carried out 
as the safety analyses.
9.3
Sample Size Justification
The sample size of 20 is needed so that the one-sided Wilcoxon signed rank test will have 
approximately 80% power to detect a p>0.5 assuming that the observed p=0.85 with 
significance level set at 0.05, where p=probability of observing a higher ordinal FLACC score 
in one sample than the other sample when comparing to a previous study.
9.4
Procedures for Accounting for Missing, Unused, and Spurious Data 
Subjects who do not comply with the requirements of this study will be dropped.  Any subject 
who withdraws from this study or is dropped for cause may be replaced to ensure that a 
minimum of 20 subjects complete the study. In the event that lost subjects have a material 
effect on the analysis of the study and the importance of the conclusions drawn from the 
study, efforts will be made to consult with the study requester and a statistician to discuss how 
to best address the issues.
9.5
Deviations to Statistical Plan
Any deviation(s) from the original statistical plan should be described and justified in the final 
report, as appropriate.

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10.0 Monitoring
3M, as sponsor of this study, is responsible for ensuring the proper conduct of the study with regard 
to protocol adherence and validity of the data recorded on the CRFs.  3M has therefore assigned a 
study monitor to this study.  The progress of the study will be monitored by:
!
Periodic on-site review
!
Telephone communications 
!
Review of CRFs and source documents (e.g. Expert Skin Grader notes, photographs, video 
recordings, etc.)
The Investigator will give the 3M study monitor direct access to source documents that support data 
on the CRFs and make available such records to authorized 3M quality assurance, IRB, and 
regulatory personnel for inspection and/or copying.
Note: The Federal Privacy rule (HIPAA) specifically permits the use and disclosure of protected 
health information “to a person subject to the jurisdiction of the Food and Drug Administration (FDA) 
[e.g. study sponsor] with respect to an FDA-related product or activity for which that person has 
responsibility, for the purpose of activities related to the quality, safety, or effectiveness of such 
FDA-regulated product or activity” [45 CFR 164.512(b)(1)(iii)].
11.0 Quality Control and Quality Assurance
3M is responsible for implementing and maintaining quality assurance and quality control systems 
through written standard operating procedures (SOPs) to ensure that this study is conducted and 
data are generated, documented and reported in compliance with the protocol, GCP and 
regulations cited in Section 1.5 of this protocol.  Study monitoring is carried out to accomplish this.
12.0 Ethics
This study will be conducted in accordance with the principles that have their origin in the 
Declaration of Helsinki, 21 CFR 50 (Informed Consent) and 56 (IRBs).
The study will start only after approval of the protocol and consent form by the IRB.  The approval 
letter or notice must contain the IRB name and identification number, meeting date, and sufficient 
information to identify the protocol and informed consent by name and number that were reviewed. 
3M, prior to study initiation, must receive a copy of the IRB approval letter.
12.1 Confidentiality
Participant confidentiality and privacy is strictly held in trust by the participating investigators, 
their staff, and the sponsor. This confidentiality is extended to cover testing of biological 
samples and genetic tests in addition to the clinical information relating to participants. 
Therefore, the study protocol, documentation, data, and all other information generated will 
be held in strict confidence. No information concerning the study or the data will be released 
to any unauthorized third party without prior written approval of the sponsor.
All research activities will be conducted in as private a setting as possible.
The study monitor, other authorized representatives of the sponsor, representatives of the 
Institutional Review Board (IRB), or regulatory agencies may inspect all documents and 
records required to be maintained by the investigator, including but not limited to, medical 

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records (office, clinic, or hospital) and pharmacy records for the participants in this study. The 
clinical study site will permit access to such records.
The study participant’s contact information will be securely stored at each clinical site for 
internal use during the study. At the end of the study, all records will continue to be kept in a 
secure location for as long a period as dictated by the reviewing IRB, Institutional policies, or 
sponsor requirements.
Study participant research data, which is for purposes of statistical analysis and scientific 
reporting, will be transmitted to and stored within 3M’s secure electronic documentation 
system, based in St. Paul, MN. This will not include the participant’s contact or identifying 
information. Rather, individual participants and their research data will be identified by a 
unique study identification number. The study data entry and study management systems 
used by clinical sites and by 3M’s research staff will be secured and password protected.
13.0 Data Handling and Record Keeping
13.1 Study Personnel
Prior to study initiation, the Investigator must provide 3M with a signed Investigator Agreement
(Statement of Investigator).  The agreement contains pertinent investigator information (e.g. 
qualifications, experience, etc.) as well as the Investigator’s commitment to conduct the study 
according to the protocol and all applicable state and federal regulations.
13.2 Pre-Study Documentation Requirements
Prior to study initiation, the Investigator must provide 3M with the following documents:
!
Signed protocol including any amendments in place prior to study initiation
!
Curriculum vitae for the Investigator and any co-investigators
!
IRB-approved consent form
!
HIPAA Authorization form
!
IRB study approval letter
!
IRB name, location and chairperson
!
IRB membership list or identification number
!
Signed investigator agreement (Statement of Investigator)
!
Signed Research Agreement
13.3 Completion and Return of Case Report Forms
Paper case report forms (CRFs) will be provided by the study center for this study.  Data may 
be recorded onto data collection sheets prior to entry on the CRFs, or it may be entered 
directly onto the CRFs.  Once the forms are completed, the monitor will review the CRFs to 
ensure accuracy and completeness.  The Investigator must review the CRFs for each subject 
in a timely fashion following completion.
13.4 Final Report

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The investigator will provide a study report detailing the conduct of the study.
3M will have an analysis performed and prepare a final study report.  The investigator will be 
provided with a copy of the report for his review and comment.  The final report will be a 
record of the total study conduct and will be subject to review by the Investigator and 3M.  
The final report will assess and summarize all data collected and include:
!
Sponsor and test material identification
!
Study procedure
!
Dates of study initiation and completion
!
Copies of the raw data
Source data for this study will be maintained according to the study site’s standard operating 
procedure.
13.5 Records, Reports and Retention Requirements
The Investigator will maintain study records for a minimum of 2 years following completion of 
the study.  Records that must be maintained by the Investigator include, but are not restricted 
to:
!
Signed study protocol, amendments, deviations
!
IRB approval of study, protocol, and consent form
!
Applications to the IRB
!
Signed consent and authorization forms
!
Case report forms
!
Adverse event reports
!
Correspondence relating to the study
!
Sponsor Final Report
14.0 References
1.
Konya C, et al. Skin Injuries Caused by Medical Adhesive Tape in Older People and Associated 
Factors. J Clinical Nurs. 2010;19:1236-1242.
2.
McNichol L, Lund C, Rosen T, Gray M. Medical Adhesives and Patient Safety: State of the 
Science. J Wound Ostomy Continence Nurs. 2013;40(4):1-15.
3.
Grove GL, Zerweck C, Houser T, Smith GE, Koski NI. Adhesive Tape Trauma Evaluation of Two 
Gentle Tapes in Health Human Subjects. Poster, SAWC 2011, WOCN 2011.
4.
Trad FR, Lampin F, Ciria ER, Fromantin I. Evaluation of the Tolerance and Benefits of a New 
Microporous Silicone Tape on Irradiated Skin. Poster, EWMA 2012.
5.
Maene B. Customer Evaluation of a New Gentle-to-Skin Medical Tape by 217 Clinical Evaluators. 
Poster, EWMA 2012.
6.
Grove GL, Zerweck C, Ekholm B, Smith GE, Koski NI. Adhesive Tape Trauma Evaluation of Two 
Gentle Tapes in Healthy Human Infant Subjects. Poster, WOCN 2012.
7.
Manriquez S. Changing Medical Tape Practice for At-Risk Skin. Poster, WOCN 2012.

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8.
Zeng LA, Lie SA, Chong SY. Comparison of 3M Kind Removal Silicone Tape vs Standard Tapes 
Durapore/Medipore on the Face in Patients at Risk of Skin Trauma under Anaesthesia. Poster, 
Would Anesthesia Congress 2013.
9.
Maene B. Hidden Costs of Medical Tape-Induced Skin Injuries. Wounds UK. 2013;9(1)46-50.
10. Grove GL, Zerweck C, Houser T, Smith GE, Koski NI. A Randomized and Controlled Comparison 
of Gentleness of 2 Medical Adhesive Tapes in Healthy Human Subjects. J Wound Ostomy 
Continence Nurs. 2013;40(1):51-59.
11. Grove, GL, Zerweck C, Ekholm B, Smith GE, Koski NI. Randomized Comparison of a Silicone 
Tape and a Paper Tape for Gentleness in Health Children. J Wound Ostomy Continence Nurs. 
2014;41(1):40-48.
12. Wong I, Chow SY, Ghadiali N, Chong SY, Tham CS. Comparison of the Use of Kind Removal 
Silicone Tape vs Micropore Paper Tape on Patients’ Eyelids under General Anaesthesia – is One 
Superior to Another? Am Soc of Regional Anesthesia and Pain Medicine. 2014;39(5):E233.
13. Manriquez S, Loperfido, B, Smith G. Evaluation of a New Silicone Adhesive Tape among 
Clinicians Caring for Patients with Fragile or At-Risk Skin. Advances in Skin & Wound Care. 
2014;27:163-170.
14. Zeng LA, Lie SA, Chong SY. Comparison of Medical Adhesive Tapes in Patients at Risk of Facial 
Skin Trauma under Anesthesia. Anesthesiology Research and Practice. 2016:1-6.

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Appendix 1
Study Schedule
Study Day
-7 to -2
-1
T0
T24
Review Inclusion/Exclusion Criteria
x
Obtain Consent and HIPAA Authorization (Parent/Legal 
Representative)
x
Acclimate Subject to Study Staff and Facility
x
Remind Parent/Legal Representative to Refrain from Applying 
Topical Medications, Creams, Powders, and Ointments on Test 
Site Area
x
Confirm Inclusion/Exclusion Criteria
x
Take Baseline Erythema Assessments
x
Apply Test Material
x
Assess Tape Lift
x
Record Video of Subject
x
Remove Test Material
x
Take Photos
x
Assess Erythema and Skin Stripping
x
Record Adverse Device Events
x
x