Clinical trial NCT04756154
Conditions: Surgical Skin Preparation
Sponsor: Solventum US LLC
Start date: 2020-07-06; Completion date: 2021-04-28
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the antimicrobial efficacy of an investigational CHG/IPA prep on skin flora of the inguinal regions of human subjects.

Detailed description:
Non-inferiority of the investigational product to the FDA-approved active control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. Non-inferiority is based on a non-inferiority margin of 0.5 log10/cm2.

Superiority of the active products to the negative control for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following application. A superiority margin of 1.2 log10/cm2 is used.

Number of observations for which the log10/cm2 recovery of skin flora on the inguinal region at 6 hours following application of the study products is higher than treatment day log10/cm2 baseline skin flora.

Arms: arm 1: Apply topically to the inguinal region for 2 minutes arm 2: Apply topically to the inguinal region for 2 minutes arm 3: Apply topically to the inguinal region for 2 minutes
Interventions: intervention 1: CHG/IPA Surgical skin preparation intervention 2: Normal saline
Intervention descriptions: intervention 1: Apply topically to the inguinal region for 2 minutes intervention 2: Apply topically to the inguinal region for 2 minutes

Protocol documents:
Prot_SAP_000.pdf: 
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Clinical Study Protocol
Study Number and Protocol Title
EM-05-014624 (MBT 109-296)
Assessment of the antimicrobial efficacy of 
3M™ SoluPrep™Preoperative Skin 
Preparation against resident human skin flora 
on the inguinal region
Principal Investigator
Sub-investigator
Research Facility 
M. Hamid Bashir, MD, CCRP
Laboratory Manager, Microbiology
Email: muhammad.bashir@microbac.com
Angela L. Hollingsworth
Director of Microbiology
Email: angela.hollingsworth@microbac.com
Microbac Laboratories, Inc
105 Carpenter Drive
Sterling, VA 20164
Telephone: 703-925-0100
FAX: 703-925-9366
IRB
Microbac Internal IRB
105 Carpenter Drive
Sterling, VA 20164
Sponsor
3M Health Care
3M Center Building 270-4N-01
St. Paul, MN  55144-1000
3M Study Monitor
Linda Olson
3M Health Care
3M Center Building 270-4N-01
St. Paul, MN  55144-1000
Telephone: 651-736-3586
FAX: 651-736-7329
Email: lkolson2@mmm.com
NCT #: NCT04756154


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3M Medical Monitor
Matthew Cooper, MD, MBA, FACS
Global Senior Medical Director &
Director Patient Safety Center of Excellence
3M Health Care
3M Center Building 270-4N-01
St. Paul, MN  55144-1000
Telephone: 651-736-4689
Approver List (3M Approvers Only):
Signer
Role
Date Signed
US113168:Morse Dan J
Clinical
May 26, 2020 06:50:44 AM CDT
US233115:Olson Linda K
Clinical
May 21, 2020 11:35:47 AM CDT
A4T08ZZ:Cooper Matthew M
Clinical
May 27, 2020 09:50:20 AM CDT
a10s7zz:Paulson Joan E
Clinical
May 26, 2020 12:35:01 PM CDT
US264576:Hupperts Ann M
Regulatory
May 25, 2020 10:24:34 PM CDT
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. 
cc:  
Clinical Study Folder
Investigator Study Documentation File (Regulatory Binder)


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Table of Contents
1.  
BACKGROUND INFORMATION........................................................................................6
1.1 Name, Description and Intended Use of the Investigational Product.......................................6
1.2 Summary of Relevant Studies......................................................................................................6
1.3 Risk/Benefit Summary.................................................................................................................7
1.4 Good Clinical Practices and Regulatory Requirements.............................................................7
1.5 Study Population...........................................................................................................................7
2.
STUDY OBJECTIVES.............................................................................................................8
3.
STUDY DESIGN.......................................................................................................................8
3.1 Study Type and Methodology......................................................................................................8
3.2 Primary and Secondary Endpoints ..............................................................................................9
3.3 Randomization and Blinding.....................................................................................................10
3.4 Study Products and Labeling.....................................................................................................12
3.4.1
Study Products ...............................................................................................................12
3.4.2
Investigational Product Labeling and Accountability.................................................12
3.4.3
Other Product Labeling.................................................................................................13
3.4.4
Additional Study Supplies.............................................................................................15
3.5 Study Duration............................................................................................................................16
3.6 Study Termination......................................................................................................................16
3.7 Source Data.................................................................................................................................16
3.8 Computerized Systems...............................................................................................................16
3.9 Protocol Modifications...............................................................................................................17
3.9.1
Protocol Amendments ...................................................................................................17
3.9.2
Protocol Deviations........................................................................................................17
4.
SUBJECT SELECTION........................................................................................................17
4.1 Subject Inclusion Criteria...........................................................................................................17
4.2 Subject Exclusion Criteria .........................................................................................................18
4.3 Subject Informed Consent..........................................................................................................19
4.4 Subject Authorization for Use and Disclosure of Protected Health Information...................19
5.
TREATMENT OF SUBJECTS ............................................................................................19
5.1 Medication(s)/Treatment(s) Not Permitted...............................................................................19
5.2 Subject Compliance....................................................................................................................20
5.3 Study Procedures........................................................................................................................20
5.3.1
Pretreatment Phase (Washout)......................................................................................20
5.3.2
Screening Phase .............................................................................................................20
5.3.3
Treatment Phase.............................................................................................................21
5.3.3.1
Preparation of Test Areas on Treatment Day...............................................21
5.3.3.2
Study Product Application.............................................................................22


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5.3.3.3
Evaluation of Skin Irritation..........................................................................22
5.3.3.4
Timing of Post-Prep Sample Collection.......................................................22
5.3.4
Microbiological Methods..............................................................................................23
5.3.4.1
Sample Collection and Processing................................................................23
5.3.4.2
Collection of Raw Data..................................................................................23
5.3.4.3
Neutralization of Investigational Materials..................................................24
5.4 Subject Discontinuation.............................................................................................................24
5.5 Subject Revocation of Authorization to Use and Disclose Protected Health Information....24
6.
ASSESSMENT OF EFFICACY ...........................................................................................24
6.1 Efficacy Parameters....................................................................................................................24
6.2 Assessment Methods..................................................................................................................25
7.
ASSESSMENT OF SAFETY ................................................................................................25
7.1 Safety Parameters .......................................................................................................................25
7.2 Assessment Methods..................................................................................................................25
7.3 Adverse Events...........................................................................................................................25
8.
STATISTICS............................................................................................................................26
8.1 Sample Size Justification...........................................................................................................26
8.2 Statistical Methods .....................................................................................................................27
8.2.1
Efficacy Analyses ..........................................................................................................27
8.2.2
Safety Analysis ..............................................................................................................27
8.3 Data Sets Analyzed.....................................................................................................................27
8.4 Criteria for the Termination of the Study..................................................................................28
8.5 Procedures for Accounting for Missing, Unused, and Spurious Data ....................................28
8.6 Deviations to Statistical Plan.....................................................................................................28
9.
MONITORING........................................................................................................................28
10.
QUALITY CONTROL AND QUALITY ASSURANCE..................................................29
11.
ETHICS ....................................................................................................................................29
12.
DATA HANDLING AND RECORD KEEPING...............................................................29
12.1 Study Personnel..........................................................................................................................29
12.2 Pre-Study Documentation Requirements..................................................................................29
12.3 Completion and Return of Case Report Forms.........................................................................29
12.4 Final Report ................................................................................................................................30
12.5 Records, Reports and Retention Requirements........................................................................30
13.
REFERENCES........................................................................................................................30
14.
APPENDICES..........................................................................................................................32


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14.1 Study Flow Diagrams.................................................................................................................32
14.2 Study Product Application Instructions....................................................................................34
14.3 Confirmation of Release & Receipt of Clinical Supplies........................................................36
14.4 Study Product Disposition Form...............................................................................................37
14.5 Subject Instructions....................................................................................................................38
14.6 Elements of Informed Consent..................................................................................................40
14.7 Test Site Diagram.......................................................................................................................42
14.8 Skin Irritation Rating Scale........................................................................................................43
14.9 Protocol for Neutralization Validation......................................................................................44
14.9.1 Background ....................................................................................................................44
14.9.2 Objective.........................................................................................................................44
14.9.3 Subject Entry Criteria....................................................................................................44
14.9.4 Test Organism................................................................................................................45
14.9.5 Study Products ...............................................................................................................45
14.9.6 Materials, Supplies and Equipment..............................................................................46
14.9.7 Study Procedures ...........................................................................................................46
14.9.7.1
Preparation of Inoculum..............................................................................46
14.9.7.2
Preparation of Test Areas and Post-Prep Sampling...................................47
14.9.7.3
Numbers Control and Toxicity Control......................................................48
14.9.7.4
Enumeration .................................................................................................48
14.9.8 Control of Bias...............................................................................................................48
14.9.9 Data Evaluation..............................................................................................................48


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1.  
BACKGROUND INFORMATION
1.1
Name, Description and Intended Use of the Investigational Product
3M™ SoluPrep™ Film-Forming Sterile Surgical Solution (SoluPrep Film-Forming Solution), an 
FDA-approved over-the-counter (OTC) drug product (NDA 208288), is an antimicrobial skin 
preparation containing the active ingredients 2% w/v chlorhexidine gluconate (CHG) and 70% 
v/v isopropyl alcohol (IPA) in combination with inactive ingredients: iso-octyl acrylate/methyl 
methacrylate/n-vinylpyrrolidone (IOA/MMA/NVP) polymer, acetyltributyl citrate (ATBC), 
trisodium hydroxylethyl ethylenediamine triacetic acid (HEDTA) and purified water (water). 
When the solution is applied to the skin, it dries to form a film. The potential benefits of this 
product, as compared with currently marketed CHG/IPA containing products without a polymer, 
include improved adhesion of incise drapes to prepped skin. In early clinical use situations, the 
performance of the SoluPrep film-forming polymer did not appropriately adhere to the patient’s 
skin, resulting in flaking or pilling of the polymer film in some cases. 3M is currently evaluating 
modifications to the quantitative formulation of the inactive ingredients in SoluPrep 
Film-Forming Solution including removal of the polymer. 
3M™ SoluPrep™Preoperative Skin Preparation (SoluPrep) is an investigational antimicrobial 
skin preparation containing 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl 
alcohol (IPA) without a polymer component. The product will be available in the following 
configurations: 10.5-mL tinted and colorless, and 26-mL tinted. The 10.5-mL tinted 
configuration will be evaluated in the current study.
3M™ CHG/IPA Film-Forming Preoperative Skin Preparation (SoluPrep FF) contains 2% w/v 
CHG and 70% v/v IPA. SoluPrep FF 10.5-mL tinted configuration will be used as the active 
control.
Sterile 0.9% saline will be used as the negative control.
1.2
Summary of Relevant Studies
SoluPrep FF has been evaluated at outside labs in 4 clinical safety studies, 1) cumulative 
irritation patch test (21 day) with challenge (EM-05-012853), 2) clinical evaluation to assess the 
phototoxicity potential (EM-05-012952), 3) clinical evaluation of photoallergy potential (EM-05-
013062), and 4) evaluation of impurities: human pharmacokinetics maximum usage trial 
(EM-05-014226). Under the conditions of these trials, the product was considered to be safe and 
well-tolerated.
Three in vivo pivotal studies (EM-05-012759, EM-05-012760, and EM-05-013260) conducted at 
outside labs to demonstrate the effectiveness of SoluPrep FF against resident skin flora showed 
that the product was well tolerated by the study populations.
Skin condition (erythema, edema, rash, dryness, and denudation) was evaluated in 3 clinical 
studies (EM-05-014626, EM-05-014733, and EM-05-014753) using a modification of the 


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SoluPrep FF formulation, which included reduction and removal of the polymer. These 3 studies 
all evaluated drape adhesion to skin. In the first 2 studies, the modified formulations used in 
combination with a surgical drape were well tolerated by the subject population, with no AEs 
reported. In the third study (EM-05-014753), 3 AEs were reported. Two of the 3 were mild in 
severity and the third was considered moderate. All 3 were probably related to the study 
products.
Refer to the Investigator Brochure (CLIN-INV-BROCH-US-05-171686) for a summary of the 
studies conducted.
1.3
Risk/Benefit Summary
There are minimal anticipated adverse health risks for the participants of this study.  
Considerable safety and efficacy data are available for the active ingredients in the 
investigational product and preclinical safety studies, as described above, have been completed. 
Application of the study products may cause skin irritation, which may manifest as minor 
redness, swelling, itching, cracking or peeling. The incidence of irritation is expected to be low, 
as is the severity of irritation. Individuals with a known history of sensitivity to acrylates, CHG-
or alcohol-containing products, medical tapes, metals, natural rubber latex, vinyl, or skin-
marking inks, will be excluded from this study.
There are no direct health benefits to subjects who participate in this study.
1.4
Good Clinical Practices and Regulatory Requirements
3M™ SoluPrep™Preoperative Skin Preparation is an investigational new drug. This study will 
be conducted in compliance with the protocol, Good Clinical Practice (GCP), and applicable 
state and federal regulations including 21 CFR 312 (Investigational New Drug Application), 50 
(Protection of Human Subjects), 56 (Institutional Review Boards), 54 (Financial Disclosure by 
Clinical Investigators), and 45 CFR 160 and 164 (Authorization for Use/Disclosure of Protected 
Health Information).
1.5
Study Population
Healthy male and female volunteers, 18 years of age or older, with no dermatological conditions 
on the test sites, or known history of sensitivity to acrylates, CHG- or alcohol-containing 
products, medical tapes, metals, natural rubber latex, vinyl, or skin-marking inks, will be 
enrolled into this study. A sufficient number of subjects will be enrolled in the screening phase, 
such that approximately 100 applications of the investigational product (10.5-mL tinted) and the 
active control (10.5-mL tinted), in addition to approximately 30 applications of the negative 
control, are evaluable for efficacy on the inguinal region (groin) at completion of the study. In 
total, 230 evaluable applications of investigational product, active control, and negative control 
would require 115 test subjects, utilizing both the right and left sides of the inguinal region. With 
the expectation that 15% of subjects will not meet treatment day baseline requirements, it is 
anticipated that 135 subjects will need to be treated. Subjects must satisfy all Screening Day and 


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Treatment Day Inclusion/Exclusion Criteria prior to collection of screening baselines and 
Treatment Day procedures. If the required numbers of subjects do not qualify from the initial 
screening group, additional volunteers will be recruited, as needed.
Each subject will be identified by a screening identification number, and a subject treatment 
number. Subject treatment numbers will not be assigned until a subject has passed the screening 
criteria, including screening baseline bacterial counts.
Both the right and left sides of the groin must meet the screening baseline requirements stated in 
the Inclusion Criteria to qualify for treatment.
2.
STUDY OBJECTIVES
The primary objective of this study is to evaluate the antimicrobial efficacy of SoluPrep by
demonstrating non-inferiority to SoluPrep FF, an FDA-approved active control, with a 0.5 
margin (log10 scale), and demonstrating a superiority margin of 1.2 log10/cm2 to saline, the 
negative control. In addition, both active products should demonstrate persistence of effect where 
the 6-hour post-treatment measurement is lower than or equal to the baseline measurement for 
100% of the subjects. 
Safety will also be evaluated based on the incidence of adverse events reported during the study 
and assessment of skin irritation ratings.
3.
STUDY DESIGN
3.1
Study Type and Methodology
This is a randomized, controlled, third-party blind, single-center study in healthy volunteers 
where each subject receives 2 of the 3 possible study products on the groin. The study staff 
performing the bacterial enumeration and the statistician performing the analysis will be blinded 
to the study products.
Table 3.1A provides a summary of the study procedures. A schematic diagram of the study is 
included in Appendix 14.1.


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Table 3.1A  Study Summary
Pre-Study 
Preparation
14-day 
Pretreatment Phase
Screening Phase
Treatment Day
Staff reviews 
study protocol
Discuss study 
procedures including 
Inclusion/Exclusion 
Criteria
Complete 
Inclusion/ Exclusion 
Criteria form
Assign sequential subject 
number
Complete
Inclusion/Exclusion Criteria 
form
Prepare 
consent form
Perform the Informed 
Consent process 
Perform visual skin 
assessment
Perform visual skin 
assessment 
Obtain IRB 
approval
Assign subject 
screening number
Collect screening 
baseline samples 
from inguinal region
Perform skin irritation rating
Recruit 
volunteers for 
Pretreatment 
Phase
Complete 
Inclusion/Exclusion 
Criteria form
Count screening 
plates, determine 
which subjects 
qualify for study
Per randomization, mark test 
areas, collect baseline 
samples from inguinal region
Prepare 
subject 
personal 
hygiene kits
Review subject 
instructions for wash 
out and dispense 
subject personal 
hygiene kit
Contact eligible 
subjects, schedule 
Treatment Day 
(schedule for 
clipping, if needed) 
Apply study products per 
randomization
If needed, perform 
clipping.
Perform skin irritation rating, 
collect 10-minute (30 sec) 
post-prep samples
Perform skin irritation rating, 
collect 6-hour (30 min) 
post-prep samples
3.2
Primary and Secondary Endpoints
Primary Endpoints:
The primary endpoints include (1) an immediate efficacy endpoint which is defined as the average 
treatment effect (ATE) log10 CFU/cm2 of skin flora on the inguinal region at 10 minutes following 
application of the study products relative to the treatment day baseline skin flora, and (2) a 
persistent efficacy endpoint which is a binary endpoint with success/failure, where “success” is 
defined as log10 CFU/cm2 of skin flora on the inguinal region at 6 hours following application of 
the study products being lower than the treatment day baseline skin flora.


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Secondary Endpoints:
Secondary microbiological endpoints are the log10/cm2 baseline skin flora, log10/cm2 recovery of 
skin flora, and log10/cm2 reduction of skin flora relative to Treatment Day baseline log10/cm2 on 
the inguinal region at 10 minutes and 6 hours following application of the study products.
The principal measure of safety will be the incidence of adverse events reported during the study 
and a summary of the skin irritation rating scores. A skin irritation rating of 3 in any category 
represents significant irritation and qualifies as an Adverse Event.
3.3
Randomization and Blinding
The left and right test areas on the subject’s inguinal region will be assigned according to a 
computer-generated randomization schedule to receive 1 of the 3 study products (see Table 
3.4.1A). Randomization will be balanced between left and right sides. There are 3 different 
combinations of treatments. These are shown below in Table 5.3.3A. To provide an ample 
number of subjects, the treatment groups will be randomized into 10 blocks of 12-2-2 for each of 
groups 1 through 3, respectively. Baseline and post-prep samplings will be randomized to sites 
within each test area. The same test site randomization will be used on each side of a subject’s 
body to reduce the possibility of sampling errors. An example of one of the blocks is shown in 
Table 3.3.1 below.
Table 3.4.1 Example Randomization
Random
-ization 
Number
Treatment 
Group
Left Groin 
Treatment
Right Groin 
Treatment
Sampling Site
Baseline
10 
Minute
6 Hour
1
1
SoluPrep FF
SoluPrep
4
2
3
2
1
SoluPrep FF
SoluPrep
3
2
4
3
1
SoluPrep
SoluPrep FF
4
2
3
4
1
SoluPrep FF
SoluPrep
3
2
4
5
1
SoluPrep
SoluPrep FF
3
4
2
6
3
Saline
SoluPrep FF
4
3
2
7
1
SoluPrep FF
SoluPrep
3
4
2
8
2
SoluPrep
Saline
2
3
4
9
1
SoluPrep FF
SoluPrep
3
4
2
10
1
SoluPrep
SoluPrep FF
4
2
3
11
1
SoluPrep
SoluPrep FF
2
4
3
12
1
SoluPrep
SoluPrep FF
3
4
2
13
3
SoluPrep FF
Saline
4
3
2


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Random
-ization 
Number
Treatment 
Group
Left Groin 
Treatment
Right Groin 
Treatment
Sampling Site
Baseline
10 
Minute
6 Hour
14
1
SoluPrep
SoluPrep FF
4
3
2
15
1
SoluPrep FF
SoluPrep
3
2
4
16
2
Saline
SoluPrep
3
4
2
The Investigator is responsible for ensuring that the study randomization is followed. 
Randomization envelopes will be provided to the study site.
The study products cannot be blinded from the Investigator or study staff performing the product 
application, sample collection and skin assessment due to the obvious differences in applicator 
design, color, and other physical characteristics. However, the study staff performing the 
bacterial enumeration will not be involved in the study product application or the collection of 
samples and, therefore, will be blinded to the study products. The statistician performing the 
analysis will also be blinded.
Randomization Plan:
A 3M statistician not assigned to the project will develop a randomization program and generate 
the randomization code list. The code list will include randomization number, treatment group, 
left side treatment, right side treatment, baseline sample site, 10-minute sample site and 6-hour 
sample site. The randomization assignments will be printed and inserted into security envelopes 
then tightly sealed.
The Clinical Data Analyst will remove the treatment assignment from the programs that are used 
to download the data from Clindex®. This will keep the statisticians and programmers assigned 
to the study blinded until data lock. 
Randomization Process:
For each eligible subject to be randomized, the investigator or designee will do the following:
●
Retrieve a randomization envelope with smallest available randomization envelop number.
●
Record randomization number onto a Data Collection Sheet (DCS) and/or the electronic Case 
Report Form (eCRF).
●
When the treatments are applied, record onto a DCS and/or the eCRF; left side treatment 
applied, right side treatment applied, baseline sample site, 10-minute sample site and 6-hour 
sample site.
●
Subjects will continue to be randomized until a minimum of 100 observations (with a 
baseline that meets the Treatment Day requirement) from each of the active treatments and 


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30 observations from the saline control (with a baseline that meets the Treatment Day 
requirement) have been collected.
3.4
Study Products and Labeling
3.4.1
Study Products
The products that will be evaluated in this study are described in Table 3.4.1A.
Table 3.4.1A  Study Products
Treatment 
Code
Study Product
Description
SP
SoluPrep 
Contains 2% w/v chlorhexidine gluconate (CHG) and 70% v/v 
isopropyl alcohol (IPA). 10.5-mL applicator, tinted.
SPFF
SoluPrep FF
Contains 2% w/v chlorhexidine gluconate (CHG) and 70% v/v 
isopropyl alcohol (IPA) in combination with an acrylate 
copolymer. 10.5-mL applicator, tinted.
S
Saline
Negative control. Sterile 0.9% saline. 20-mL bottle.
The SoluPrep products will be applied topically to intact skin of the inguinal (groin) region of the 
subject. The prep will be applied with repeated back-and-forth strokes for 2 minutes and allowed 
to dry for 3 minutes.
The saline control will be applied with repeated back-and-forth strokes for 2 minutes on the 
groin using sterile polyurethane foam applicators, aseptically saturated with 20 mL of solution, 
and allowed to dry for 3 minutes.
Detailed instructions for application and removal of the study materials are provided in the 
Investigational Product Application Instructions (Appendix 14.2).
3.4.2
Investigational Product Labeling and Accountability
3M will label, package and ship the study products to the research facility. SoluPrep will be 
provided in individual sterile packages and labeled as below.


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Sample Investigational Product Label (ie, SoluPrep)
CAUTION: New Drug-Limited by Federal Law to Investigational Use
For use in study EM 05-014624 (MBT 109-296) only.
3M Health Care, St. Paul, MN 55144-1000
Topical Patient Prep (10.5-mL)   Subject Number:
Product ID: 42-0037-0388-3
Treatment Code: SP
Directions: Use as directed in protocol
Warning:  Contents are flammable until dry.
3M requires Investigators to maintain accountability and adequate inventory security of the study
products at all times. The Investigator or designee will: 
●
Document receipt of study products on the Confirmation of Release & Receipt of Clinical 
Supplies form (Appendix 14.3) and return the completed form to 3M, 
●
Store study products in a secure facility accessible only to authorized individuals,
●
Dispense study products only to subjects properly enrolled into the study,
●
Account for inventory and disposition using the Study Product Disposition Form (Appendix 
14.4), and
●
Return all used and unused study products to 3M or dispose of used and unused study
products as agreed upon. NOTE: The subject number will be recorded on the package label 
and retained for inventory purposes. Used applicators can be discarded.
In addition, copies of all completed Study Product Disposition Forms must be retained in the 
Investigator Study Documentation File. The originals of all Study Product Disposition Forms
must be sent to the Sponsor’s Clinical Monitor.
3.4.3
Other Product Labeling
SoluPrep FF active control will be provided in original marketed packaging with an over label, 
as below, placed on each applicator pouch.


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Sample Marketed Active Control Label (ie, SoluPrep FF)
Commercialized Product – For use only as directed below
Study No: EM 05-014264 (MBT 109-296)
3M Health Care, St. Paul, MN 55144-1000
Topical Patient Prep (10.5-mL)   Subject Number: 
Product ID: 70-2007-8768-0
Treatment Code: SPFF
Directions: Use as directed in protocol
Warning:  Contents are flammable until dry.
The saline solution will be supplied in original marketed 20 mL bottles and box will be 
overlabeled as below.
Sample Negative Control Label (ie, saline 20 mL bottles)
For use only as directed below
Study No: EM 05-014264 (MBT 109-296)
3M Health Care, St. Paul, MN 55144-1000
Saline (20 mL)
Product ID: Hospira #00409488820
Treatment Code: S
Directions:  Use as directed in protocol
The sterile polyurethane foam applicators used for saline application will be provided in 
individual sterile packages labeled as below.
Sample Negative Control Foam Applicator Label (ie, saline applicators)
For use only as directed below
Study No: EM 05-014264 (MBT 109-296)
3M Health Care, St. Paul, MN 55144-1000
Saline Applicator
Subject Number:
Treatment Code: S
Directions:  Use as directed in protocol


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3.4.4
Additional Study Supplies
Sponsor will provide the following:
●
Study Product Disposition Forms
●
Randomization schedule
●
Data Collection Sheets (DCSs)
●
Study products
●
Triacetin (Glyceryl triacetate)
Study site will provide the following:
●
Subject Informed Consent / HIPAA Authorization forms, IRB-approved
●
Product kits (toiletry items to be used by subjects during study)
●
Standard Sampling Solution (SSS), 75mM phosphate buffer (0.04% monobasic potassium 
phosphate, and 1.01% dibasic sodium phosphate) containing 0.1% Triton® X-100, 0.3% 
lecithin, 3.0% polyoxyethylene sorbitan monooleate (Tween® 80), and 1.0% Tamol™ SN; 
pH 7.9 + 0.1, sterile
●
Butterfield’s sterile phosphate buffered water1 (PBW), 312 μM KH2PO4, pH 7.2 ± 0.1
●
High-purity deionized water, sterile
●
Trypticase soy agar containing 0.5% Tween 80 and 0.07% lecithin (TSA+N)
●
Disposable undergarments
●
Gloves, sterile
●
Sterile, non-occlusive dressings (to cover treated test sites)
●
Alcohol wipes
●
Transfer pipettes, polyethylene, sterile
●
Serological pipettes, 1 mL, 2 mL, and 10 mL, sterile
●
Pipettor, calibrated to accurately deliver volumes of 0.5 mL, 2.5 mL and 3.0 mL, and sterile 
tips
●
Tubes with sealable caps, polypropylene or glass, sterile
●
Petri dishes, 100-mm, sterile
●
Surgical clippers with blades
●
Sterile marking templates, 1.5” x 5” (for marking test sites)
●
Non-toxic marking pen (Sharpie or equivalent), sterile (Note: Do not use markers containing 
crystal violet)
●
Scrub cups (2.20 cm I.D., 3.80 cm2), sterile
●
Teflon or rubber policemen, sterile
●
Timers or stopwatches
●
Pipette-Aid® or similar apparatus
●
Vortex mixer
●
Water bath (45 ± 2C)
●
Incubator (30 ± 2C)


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3.5
Study Duration
The expected duration of this study for each subject is up to 4 weeks. Each subject’s 
participation will involve at least a 14-day Pretreatment Phase (washout), a 1-day Screening 
Phase, and a 1-day Treatment Phase. Following the Pretreatment Phase, each subject will be 
required to visit the test facility on an arranged date for collection of screening baseline samples 
from the inguinal region. Subjects will remain on washout until notified that they do or do not 
qualify for the study. Subjects whose screening baseline samples meet the requirements
described in the Inclusion Criteria (Section 4.1) will be notified and invited to participate in the 
Treatment Phase of the study. The Treatment Phase will be scheduled no sooner than 72 hours 
from the screening baseline collection. Each subject who chooses to participate in this study will 
be required to return to the test facility for treatment and again within 6 hours of treatment for the 
final sampling. Table 3.1A indicates the sequence of events throughout the study and a schematic 
diagram of the study is included in Appendix 14.1.
3.6
Study Termination
Conditions that may warrant termination of the study by 3M include, but are not limited to the 
following:
●
The discovery of an unexpected, serious, or unreasonable risk to study subjects,
●
Insufficient adherence to protocol requirements,
●
Failure of the Investigator to enroll subjects into the study at an acceptable rate,
●
Failure of the Investigator to comply with either pertinent FDA regulations or federal (eg, 
HIPAA) and state privacy regulations,
●
Submission of knowingly false information from the Investigator to 3M,
●
Termination of IND or IRB approval, or
●
A decision on the part of 3M to suspend or discontinue evaluation of the investigational 
product.
3.7
Source Data
Electronic data capture (eDC) will be used for this study. If not entered directly into eDC, data 
will first be recorded onto a DCS, followed by entry into the appropriate electronic Case Report 
Form (eCRF). Wherever the data are entered first is considered the source document.
3.8
Computerized Systems
●
Clindex® 4.4
●
SAS® 9.4 or later
●
R 3.4.0 or later
●
Minitab 17 or later
●
Excel for Office 365


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3.9
Protocol Modifications
3.9.1
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 significant protocol amendments to the FDA and Investigator for submission to 
the IRB. 3M will also notify the Investigator when a protocol amendment may be implemented.
3.9.2
Protocol Deviations
A deviation is a departure from the protocol that will likely affect the safety, rights or welfare of 
subjects, the scope of the investigation, or the scientific quality of the study.
A protocol deviation is only for an individual subject. Protocol deviations are documented on a 
Protocol Deviation Form.
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. 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. If the deviation affects subject safety, 
rights or welfare, a copy is sent to the 3M study monitor within 24 hours of identifying the 
occurrence.
Deviations, which are made to protect the life or physical well-being of a subject in an 
emergency, must be reported by the Investigator to the IRB within 5 working days of 
occurrence and by 3M to the FDA within 5 working days after 3M learns of the 
occurrence.
4.
SUBJECT SELECTION
4.1
Subject Inclusion Criteria
Subjects to whom all of these conditions apply will be eligible for enrollment in this study:
●
Subjects of either sex and any race who are at least 18 years of age,
●
Subjects must be in good general health,
●
Subjects who satisfy all Inclusion/Exclusion Criteria and will voluntarily read and sign the 
Informed Consent Form including authorization to use and disclose protected health 
information,
●
Subjects who are cooperative and willing to follow Subject Instructions for the study 
(Appendix 14.5),


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Subjects who are willing to report to the study facility approximately 72 hours prior to 
Screening or Treatment Day sampling for clipping, if needed,
●
Subjects who are willing to avoid showering and tub-bathing within 72 hours prior to 
Screening and Treatment Days (sponge-baths may be taken; however, the groin and upper 
thigh regions must be avoided),
●
Subjects who are willing to avoid showering, tub-bathing, swimming, and vigorous physical 
activity that may cause sweating during the 6-hour ± 30-minute period before the final 
sampling,
●
Subjects who are willing to return to the study facility within 6 hours of treatment for the 
final sampling, and
●
Subjects who have Screening Day baseline counts of > 5.00 log10 per cm2 bilaterally on the
inguinal region.
4.2
Subject Exclusion Criteria
Subjects to whom any of these conditions apply will be excluded from this study:
●
Participation in another clinical study in the past 30 days, current participation in another 
clinical study, or previous participation in this study,
●
Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders 
(including acne) on the applicable test areas,
●
A history of skin allergies,
●
A history of skin cancer within 6 inches of the test areas,
●
Known sensitivity to acrylates, CHG- or alcohol-containing products, medical tapes, metals, 
natural rubber latex, vinyl, or skin-marking inks, 
●
A medical diagnosis with physical condition that may put the subject at risk, such as a 
current or recent severe illness, hepatitis, organ transplant, congestive heart disease, or any 
immunocompromised conditions, such as AIDS (or HIV positive),
●
Any medical condition or use of any medications that, in the opinion of the Investigator, 
should preclude participation,
●
Pregnancy, possible pregnancy, attempting pregnancy, or nursing,
●
Topical antimicrobial exposure within 14 days prior to Screening and Treatment Days. 
Restrictions include, but are not limited to, antimicrobial soaps, medicated shampoos, 
medicated lotions, antiperspirants/deodorants, perfumes, after shaves, and colognes,
●
Use of systemic or topical antibiotic medications, steroid medications (other than for 
hormonal contraception or postmenopausal reasons), or any other product known to affect 
the normal microbial flora of the skin within 14 days prior to Screening and Treatment Days,
●
Use of topically applied or oral antihistamine medications in the last 48 hours (eg, Claritin®, 
Benadryl®, Zyrtec®, Singulair®, Cromolyn, Nyquil™, Tylenol® PM),
●
Exposure of the test areas to solvents, acids, bases, strong detergents, fabric softener-treated 
clothing, or other household chemicals within 14 days prior to Screening and Treatment 
Days,
●
Swimming in chemically treated pools or bathing in hot tubs, spas, or whirlpools within 14 
days prior to Screening and Treatment Days,


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Use of tanning beds, hot waxes, or depilatories (in the applicable test areas) within 14 days 
prior to Screening and Treatment Days, or
●
Bathing and showering within 72 hours prior to Screening and Treatment Days.
4.3
Subject Informed Consent
The Investigator or designee 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 or designee must provide the prospective subject or the 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 all the information that they need, 
2) ensure that the subject understands the information and 3) give the subject a chance to consider 
study participation. The process should permit the subject to ask questions and exchange 
information freely.
Specifically, the Investigator or designee is to explain to each subject all elements of informed 
consent as specified in 21 CFR 50.25 (Appendix 14.6). After the explanation, the subject or 
representative will voluntarily sign and date the consent form if they wish to participate in the 
study. A copy of the consent form must be provided to the subject. A signed and dated copy of the 
consent form must be maintained in the Investigator study documentation file at all times. 
Consent and study participation, with date, must be documented in the subject’s record.
4.4
Subject Authorization for Use and Disclosure of Protected Health Information
The Investigator or designee 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 or designee is to explain to each subject all elements of 
authorization as specified in 45 CFR 164.508. After the explanation, the subject or representative 
must voluntarily sign and date the authorization form if they wish to participate in the study. A 
copy of the authorization form must be provided to the subject. 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 record.
An authorization form may be combined with a consent form (ie, compound authorization) if 
required by the IRB. All required elements for both informed consent and authorization must be 
included in a compound authorization.
5.
TREATMENT OF SUBJECTS
5.1
Medication(s)/Treatment(s) Not Permitted
Exposure of the test areas to antimicrobial agents is not permitted within 14 days prior to 
Screening Day and for the duration of the study. Restrictions include, but are not limited to 


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antimicrobial soaps, antiperspirants/deodorants, shampoos, lotions, perfumes, after shaves, 
colognes, steroid medications (other than for hormonal contraception or postmenopausal 
reasons), and topical or systemic antibiotics.
5.2
Subject Compliance
Answers to the Inclusion/Exclusion Criteria questions asked at the beginning of the Screening 
and Treatment Phases, and prior to the final sample collection will determine compliance to the 
Subject Instructions (Appendix 14.5) provided to each subject upon study participation.
5.3
Study Procedures
These study procedures are based on ASTM E1173-15, Standard Test Method for Evaluation of 
Preoperative, Precatheterization, or Preinjection Skin Preparations.2
5.3.1
Pretreatment Phase (Washout)
The Inclusion/Exclusion Criteria will be reviewed with each subject to ensure eligibility for the 
study. If these criteria are satisfied, subjects will sign the consent form. Prior to the scheduled 
Screening Day, subjects will undergo a minimum 14-day pretreatment phase to allow for the 
removal of any antimicrobial agents from the subjects’ skin. Subjects are to refrain from the use 
of products containing antibacterial agents as written in the Subject Instructions (Appendix 14.5). 
Subjects will be given personal hygiene kits containing nonantimicrobial products for use during 
this period. Subjects will be instructed to use these products through completion of the Treatment 
Phase or until notified by the Investigator or designee.
In addition, subjects must avoid systemic or topical antibiotics or medications and contact with 
chemically treated swimming pools or hot tubs, hot waxes, and depilatories on the test areas for 
14-days before the scheduled Screening Day. If it becomes necessary to take systemic antibiotics 
or to apply topical medications to the test areas within this pretreatment period, the subject must 
contact the Investigator as soon as reasonably possible so that another volunteer may be 
recruited.
If subjects require hair removal to facilitate sample collection, the subject will be asked to return 
to the test facility approximately 72 hours before the Screening Day. Subjects will not be allowed 
to shower or bathe for 72 hours prior to their scheduled screening appointment. Sponge-baths 
may be taken; however, the groin and upper thigh regions must be avoided.
5.3.2
Screening Phase
Prior to collection of the screening baseline samples, the Investigator or a designee will complete 
the screening Inclusion/Exclusion form. A visual skin assessment of the test areas will be 
performed, and the screening baseline samples will be collected using the cup scrub technique 
described in Section 5.3.4.1. Baseline samples will be taken from the center of each contralateral 
test area within the inguinal region.


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Samples from both the left and right sides of the inguinal region must meet the values indicated 
in the Inclusion Criteria to be enrolled into the Treatment Phase of the study. Those subjects who 
qualify will be notified and will continue to follow the instructions in Appendix 14.5 until 
completion of the scheduled Treatment Day. Subjects will not be allowed to shower or bathe for 
72 hours prior to Treatment Day. Sponge-baths may be taken; however, the groin and upper 
thigh regions must be avoided.
5.3.3
Treatment Phase
A sufficient number of subjects who meet the Inclusion Criteria will be enrolled into the 
Treatment Phase of the study, such that approximately 230 inguinal regions are evaluable for 
efficacy at completion of the study. Table 5.3.3A lists the treatment groups that will be divided 
amongst the subjects.
Due to the film-forming component of SoluPrep FF, a modification of the sampling solution is 
required to dissolve the film for bacterial recovery (see Section 5.3.4.1). The agent used to 
accomplish this is Triacetin, a fully saturated triglyceride.  
Table 5.3.3A  Subject Treatments
Treatment 
Combination
Left and Right Treatment
1
SoluPrep 10.5-mL and SoluPrep FF 10.5-mL
2
SoluPrep 10.5-mL and saline
3
SoluPrep FF 10.5-mL and saline
The Investigator or a designee will complete the treatment Inclusion/Exclusion form.  If these 
criteria are satisfied, a visual skin assessment will be performed to evaluate the condition of each 
test area.
5.3.3.1
Preparation of Test Areas on Treatment Day
A Test Site Diagram for the inguinal test area is shown in Appendix 14.7.
The test area within the inguinal region is defined as the uppermost inner aspect of the thigh (the 
groin), centering the long axis of the template along the inguinal crease immediately below the 


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groin. If, due to a subject’s anatomy, the test area cannot be centered along the inguinal crease, 
the area should be positioned on the upper, inner thigh as close to the crease as possible. In no 
instance should sampling be performed on areas not having skin-to-skin contact. Using a 1.5” x 
5” sterile template, the corners of each inguinal test area will be marked directly on the skin 
using a non-toxic skin marker. Four sampling sites will be numbered within each inguinal test 
area. The positioning and numbering of the inguinal sampling sites are standard for all subjects. 
Sampling sites on the contralateral side of the groin will be numbered in a mirror-image 
orientation. The 4 sampling sites within each inguinal test area represent one baseline (pre-prep) 
site, 2 post-prep sample sites (10-min, 6-hr), and an unused site. Sampling sites 2, 3 and 4 will be 
randomized as baseline and the 2 post-prep sample sites. Sampling site 1 is designated as the 
unused sample site.
After inguinal test areas are marked and sample sites are numbered, baseline samples will be 
collected from the right and left test areas per the randomization schedule using the cup scrub 
technique described in Section 5.3.4.1.
5.3.3.2
Study Product Application
Following baseline sample collection, the contralateral inguinal test areas will each be prepped 
with 1 of the 3 study products according to the randomization codes provided. Treatments will be 
randomized between left and right test areas and post-prep sampling times will be randomized 
amongst the sampling sites within a test area.
The study products will be applied per the randomization schedule and the Investigational 
Product Application Instructions (Appendix 14.2). The duration of each prep procedure will be 
recorded on the appropriate form.
5.3.3.3
Evaluation of Skin Irritation
Prior to collection of the baseline, 10-minute, and 6-hour post-prep samples, the skin in each test 
area will be evaluated for indications of skin irritation, based on the Skin Irritation Rating Scale 
(Appendix 14.8). Skin irritation ratings for each area will be recorded on the Skin Irritation 
Rating form. A rating of 3 in any category during the evaluations for the 10-minute, and 6-hour 
post-prep samples represents significant irritation and qualifies as an Adverse Event. Any area 
with a rating of 3 should not be sampled.
5.3.3.4
Timing of Post-Prep Sample Collection
Microbial samples will be collected at 10 minutes (30 sec.) and 6 hours (30 min.) post-prep 
from the groin. Post-prep timing begins upon completion of study product application, including 
the 3-minute drying time. Microbial samples will be collected using the cup scrub technique 
described in Section 5.3.4.1.
After the 10-minute post-prep samples have been collected, a sterile non-occlusive dressing will 
be secured over the remaining sample sites to allow subjects restricted mobility and to protect the 


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sites from contamination between sampling times. The subjects will be allowed to leave the 
clinical test facility as long as they return within 6 hours for collection of the 6-hour samples.
Subjects should be reminded that they are to avoid showering, tub-bathing, swimming, vigorous 
physical activity that may cause sweating, and any other activities that may compromise the 
integrity of the test sites until their final sample collection has been completed. In the event that 
the dressing on the 6-hour test site has been compromised, the site will be sampled and the loss 
of dressing integrity will be recorded on the appropriate DCS.
Following the final sample collection, residual study products will be removed from the subject’s 
skin with alcohol wipes.
5.3.4
Microbiological Methods
5.3.4.1
Sample Collection and Processing
Quantitative cultures will be obtained from test sites using a modification of the cup scrub method 
of Williamson and Kligman.3 Modified sampling solution (MSS) will be used to collect all 
microbial samples.
Modified Sampling Solution (MSS):
A sterile scrub cup will be placed and held firmly on each site. Scrub 1:  1.0 mL of Triacetin and 
2.0 mL of SSS will be aseptically pipetted into the scrub cup. The skin will be scrubbed in a 
circular motion with moderate pressure for 1 minute using a sterile policeman. Using a sterile 
transfer pipette, the scrub solution will be transferred to a sterile collection tube. Scrub 2:  An 
additional 3.0 mL of fresh SSS will be pipetted into the scrub cup and the scrub procedure will be 
repeated. This solution will be pooled with the solution from Scrub 1 for a total sample volume of 
approximately 6 mL per site.
Following collection, each sample tube will be capped tightly and pulsed 3 times on a vortex 
mixer followed by a 2-minute sonication and 30-second vortex. A 1.0 mL aliquot of each sample 
will be diluted into sterile tubes containing 9.0 mL PBW. Serial 10-fold dilutions will be 
performed in PBW. One-milliliter (1.0-mL) aliquots of selected dilutions will be pour-plated in 
triplicate using TSA+N. Samples must be plated within 30 minutes of collection. Plated 
samples must be well swirled. Each plate should be labeled with the subject treatment number, 
anatomical region sampled (groin), test site sampled (right or left and time point), and dilution 
plated. After 72 (± 4) hours of aerobic incubation at 30 ± 2°C, colonies will be counted and 
viable cells in the original sample will be calculated using standard methods. Following 
incubation, plates may be refrigerated for up to 48 hours prior to counting.
5.3.4.2
Collection of Raw Data
Raw colony counts from each of the dilutions will be recorded on the appropriate DCS for each 
subject.


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Based on the scrub and dilution process, in order to have a baseline > 5.0 log10 requires that the 
average of the 3 plates from the 10-3 dilution be > 63. Averaging of the Screening Day counts 
will be automatically performed on the eCRF upon entry of raw data and Clindex will determine 
the subject’s eligibility for treatment.
5.3.4.3
Neutralization of Investigational Materials
The effectiveness of the neutralizers contained in the microbial sampling solution will be tested 
based on ASTM E1054-08 (Reapproved 2013), Standard Test Methods for Evaluation of 
Inactivators of Antimicrobial Agents,4 prior to Treatment Day. The Protocol for Validation of 
Neutralizer Effectiveness is provided in Appendix 14.9.
5.4
Subject Discontinuation
The Investigator or designee may discontinue individual subjects from the study at any time.  
Subjects may voluntarily withdraw from the study at any time. The Investigator or designee will 
provide a written report on the appropriate form including the date and reason for 
discontinuation. Subjects who have been previously screened may not be re-entered into the 
study.
5.5
Subject Revocation of Authorization to Use and Disclose Protected Health 
Information
In order to implement a valid revocation of authorization, the subject or their representative must 
make the request in writing to Microbac Laboratories, Inc., 105 Carpenter Drive, Sterling, VA, 
20164. The revocation cannot stop the use or disclosure of information that has been collected 
and disseminated prior to the revocation, is needed to ensure complete and accurate study results, 
and is required by law or government regulation (eg, reporting adverse events). 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.
6.
ASSESSMENT OF EFFICACY
6.1
Efficacy Parameters
Non-inferiority of the investigational product to the FDA-approved active control for log10/cm2
recovery of skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 
minutes following application. Non-inferiority is based on a non-inferiority margin of 0.5 
log10/cm2.
Superiority of the active products to the negative control for log10/cm2 recovery of skin flora 
relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes following 
application. A superiority margin of 1.2 log10/cm2 is used.


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Number of observations for which the log10/cm2 recovery of skin flora on the inguinal region at 6 
hours following application of the study products is higher than treatment day log10/cm2 baseline 
skin flora.
6.2
Assessment Methods
Efficacy will be assessed by sampling the skin using the cup scrub method described in Section 
5.3.4.1.
7.
ASSESSMENT OF SAFETY
7.1
Safety Parameters
The principal measure of safety will be the incidence of adverse events reported during the study 
and a summary of the skin irritation rating scores. A skin irritation rating of 3 post-treatment in 
any category represents significant irritation and qualifies as an Adverse Event.
7.2
Assessment Methods
The Investigator or designee will assess the subject’s skin condition prior to collection of the 
baseline, 10-minute, and 6-hour post-prep samples using the Skin Irritation Rating Scale 
(Appendix 14.8).
7.3
Adverse Events 
The Investigator is responsible for identifying adverse events that occur to each subject on 
Treatment Day. An adverse event can be identified by the Investigator or reported by the subject.
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. This use and 
disclosure is subject to the minimum necessary standard, ie, “the minimum necessary to 
accomplish the intended use, disclosure, or request.”
Definitions
●
Adverse event (AE) means any undesirable clinical occurrence in a subject whether or not it 
is considered to be drug related.
●
Drug-related adverse event (ie, adverse drug experience) is an adverse event that is 
considered by the Investigator to have a reasonable likelihood of being associated with the 
investigational drug.
●
Life-threatening adverse drug experience is any adverse drug experience that places the 
subject, in the view of the Investigator, at immediate risk of death from the reaction as it 


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occurred (does not include a reaction that, had it occurred in a more severe form, might have 
caused death).
●
Serious adverse drug experience is an adverse drug experience that is fatal or life-threatening, 
is permanently or significantly disabling/incapacitating, requires inpatient hospitalization or 
prolongation of existing hospitalization, or results in a congenital anomaly/birth defect.
●
Unexpected adverse drug experience is one not previously identified in nature, severity or 
frequency of incidence in the current Investigator brochure, in the clinical plan, or elsewhere 
in the current IND application and amendments.
Recording and Reporting
The Investigator records each AE occurring in the study, including those not thought to be 
associated with the drug, on the Adverse Event Record. Documentation includes the AE 
description, severity at onset, seriousness, date of onset and resolution, relationship to the 
investigational drug, action taken, and outcome.
The Investigator must promptly report all adverse drug experiences to the 3M study monitor. If 
the adverse drug experience is also considered by the Investigator to be serious and/or 
unexpected the Investigator must report it to the IRB as soon as possible.
3M reports (by telephone or fax) a death or life-threatening adverse drug experience to the FDA 
within 7 days of notification and submits a follow-up report within 15 days.
A serious and unexpected adverse drug experience involving a non-3M commercialized product 
is reported to the 3M study monitor and IRB.
If a subject does not experience an AE during the study, the absence of such must be recorded on 
the form.
8.
STATISTICS
8.1
Sample Size Justification
The Final Monograph (21 CFR Part 310 Safety and Effectiveness of Health Care Antiseptics; 
Topical Antimicrobial Drug Products for Over-the-Counter Human Use)5 calls for a minimum of 
100 observations per treatment. A standard deviation of 1.0 log10/cm2 was observed in study 
EM-05-012760. One-hundred subjects per treatment arm provides 94% power using a non-
inferiority margin of 0.5 log10/cm2 with a 1-sided alpha of 0.025.
In the same study, a superiority to the negative control was observed to be approximately 2.5 
log10/cm2, with a lower 95% confidence bound of 2.26 log10/cm2. A sample size of 30 for the 
negative control will ensure that the mean for log10/cm2 reduction of skin flora relative to 


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Treatment Day baseline will be normally distributed. Power was assessed through simulation 
using an assumed superiority of 2.26 log10/cm2 (the lower 95% confidence bound observed in 
study EM-05-012760), sample sizes of 30 for the negative control and 100 for the active 
treatments, and the standard deviation of 1.0 log10/cm2 mentioned above. All 1000 simulations 
had a lower bound for superiority greater than 1.2 log10/cm2.
8.2
Statistical Methods
8.2.1
Efficacy Analyses
Primary Efficacy Analyses:
The average treatment effect (ATE) for the investigational product will be estimated using a 
linear regression of the 10-minute post-treatment bacterial count (log10 scale) on the additive 
effect of a treatment indicator and the baseline measurement (log10 scale). The lower bound of 
the 95% confidence interval for the additive treatment effect must not include the investigational 
product being more than 0.5 log10/cm2 lower than the positive control.
The ATE of the test product compared to the negative control is estimated as the contrast of 
treatment effect of negative control minus the treatment effect of the test drug in the linear 
regression. Likewise, the ATE of the active control compared to the test product is estimated as 
the contrast of treatment effect of test product minus the treatment effect of the active control in 
the linear regression. Superiority to negative control uses a margin of 1.2 log10/cm2, which would 
be demonstrated by a lower bound of the 95% confidence interval for the contrast to exceed 1.2 
log10/cm2.
The percent of samples for which the 6-hours post treatment recovery is lower than the baseline 
recovery will be calculated by active product. The Final Monograph requires that these
percentages be 100.
Secondary Efficacy Analyses:
Summary tables will be produced by treatment for log10/cm2 baseline skin flora, log10/cm2
recovery of skin flora, and log10/cm2 reduction of skin flora relative to Treatment Day baseline 
log10/cm2 on the inguinal region at 10 minutes and 6 hours following application of the study 
materials. The tables will include number, mean, standard deviation, minimum and maximum.
8.2.2
Safety Analysis
Adverse events and skin irritation scores will be summarized by product.  
8.3
Data Sets Analyzed
A modified intent-to-treat data set will be used for primary efficacy analysis. All subjects who 
meet baseline requirements on a bilateral side will be included in the analysis for that bilateral 
side. However, the primary analyses involve a linear regression at the 10-minute post-treatment 


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time point and calculation of return to baseline at 6 hours. These analyses cannot be done 
without both baseline and 10-minute recovery for treatment effect or baseline and 6-hour 
recovery data for return to baseline percentage calculation. The exclusion of subjects who do not 
meet baseline requirements and who are missing recovery data at one or both of the 
post-treatment sampling times makes this data set a modified intent-to-treat data set.
The baseline bacterial count requirements are in the range of 5.00 to 7.50 log10/cm2 on the groin. 
The acceptability of each bilateral baseline will be assessed separately for inclusion in the study.
The full intent-to-treat data set (all randomized subjects) will be used for the safety analysis.
8.4
Criteria for the Termination of the Study
3M reserves the right to terminate the study at any time for business reasons.
8.5
Procedures for Accounting for Missing, Unused, and Spurious Data
Details of any other missing data handling will be specified in the statistical analysis plan.
8.6
Deviations to Statistical Plan
A statistical analysis plan (SAP) will be written and approved prior to study initiation. Any 
deviation from the original SAP will be described and justified in the final report.
9.
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. 3M has therefore assigned a study 
monitor to this study. The progress of the study will be monitored by:
●
Periodic on-site review
●
Ongoing review of electronic documentation via Clindex
●
Telephone and e-mail communications 
●
Review of source documents
The Investigator or designee will give the 3M study monitor direct access to source documents 
that support data on the eCRFs 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) 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.”


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10. 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 1.4 of this protocol. Study monitoring is carried out to 
accomplish this.
11. 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, 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. DATA HANDLING AND RECORD KEEPING
12.1 Study Personnel
Prior to study initiation, the Investigator must provide 3M with a signed Form FDA 1572. 
This form identifies all sub-investigators who will be assisting the Investigator in the 
conduct of the study. The Investigator will provide a log of signatures/initials prior to 
study initiation.
12.2 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 sub-investigators
●
IRB approved consent/authorization form
●
IRB study approval letter
●
IRB name, location and chairperson
●
IRB membership list
●
Signed Form FDA 1572
●
Financial Disclosure documents per 21 CFR 54
●
Signed research agreement
12.3 Completion and Return of Case Report Forms
Electronic data capture (eDC) will be used for this study. The site will be trained on the eDC 
software prior to study enrollment. The site will be provided with a manual, including 
instructions on how to complete the eCRFs and how to make eCRF corrections within the eDC 
software. Microbiological count data will be recorded onto DCSs prior to entry into the eDC 


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system. The Investigator must review and electronically sign eCRFs in a timely fashion 
following the 3M study monitor’s review.
12.4 Final Report
The Investigator will submit an Investigator Final Report to 3M within one month of the 
completion of statistical analysis or termination of the study. 3M will be provided a draft 
Investigator Final Report for review. The Investigator will make reasonable changes deemed 
necessary by 3M and finalize. The Investigator will submit the Investigator Final Report to 3M 
and the IRB. 
3M will prepare and submit a Sponsor Final Report to the FDA. The study medical monitor will 
sign the Sponsor Final Report.
12.5 Records, Reports and Retention Requirements
Study records must be kept until 3M provides notification that the documents can be destroyed. 
This may extend beyond the 2 years required by law. In order to comply with regulatory 
requirements, the Investigator must arrange for the retention of all study records for 2 years 
following the date a marketing application is approved for the drug and indication investigated, 
or if no application is filed, until 2 years after completion/termination of the study.
Records to be retained by the Investigator include, but are not restricted to:
●
Signed study protocol, amendments, deviations
●
IRB approval of protocol, consent form, authorization form, waiver of consent and/or 
authorization and amendments to any of these documents
●
Applications to the IRB
●
Signed consent/authorization forms
●
DCSs
●
eCRFs
●
Records of receipt, use or disposition of the investigational drug
●
Correspondence relating to the study
●
Investigator Brochure
●
Financial disclosure documents
●
Sponsor Final Report
●
Investigator Final Report
13. REFERENCES
1
Butterfield, CT. The selection of a dilution water for bacteriological examinations. J 
Bacteriol 1932; 23: 355–68.
2
ASTM International. ASTM E1173, standard test method for evaluation of preoperative, 
precatheterization, or preinjection skin preparations. West Conshohocken [PA]: ASTM Int’l; 
2015.


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3
Williamson P, Kligman PM. A new method for the quantitative investigation of cutaneous 
bacteria. J Invest Dermatol 1965; 45:498-503.
4
ASTM International. ASTM E1054, standard test methods for evaluation of inactivators of 
antimicrobial agents.  West Conshohocken [PA]: ASTM Int’l; 2013.
5
US Food and Drug Administration. Safety and effectiveness of health care antiseptics; 
topical antimicrobial drug products for over-the-counter human use. Final rule. Federal 
Register 2017; 82:60474-503.


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14. APPENDICES
14.1 Study Flow Diagrams
Screening


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Treatment


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14.2 Study Product Application Instructions
Study personnel must use sterile gloves to apply the solutions.
Treatment Code: SP (SoluPrep)
1. Aseptically remove investigational product from sterile packaging and maintain sample in a 
sterile environment prior to sample application.
2. With the sponge in a downward position, snap the lever on the applicator allowing the fluid 
to flow into the sponge. Wait until the sponge fills completely.
3. Apply the product with repeated back-and-forth strokes for 2 minutes on the groin.
4. Do not allow solution to pool. Use sponge applicator to absorb excess solution and continue 
to apply.
5. Allow the test area to dry for 3 minutes.
6. Contact time begins after step 5.
7. Residual product should be removed from test areas after the final sample collection is 
complete using alcohol wipes or soap and water.
8. Record the subject number on the package label and retain for inventory purposes. Discard 
used applicators.
Treatment Code: SPFF (SoluPrep FF)
1.
Aseptically remove investigational product from sterile packaging and maintain sample in a 
sterile environment prior to sample application.
2.
With the sponge in a downward position, snap the lever on the applicator allowing the fluid 
to flow into the sponge. Wait until the sponge fills completely.
3.
Apply the product with repeated back-and-forth strokes for 2 minutes on the groin.
4.
Do not allow solution to pool. Use sponge applicator to absorb excess solution and continue 
to apply.
5.
Allow the test area to dry for 3 minutes.
6.
Contact time begins after step 5.
7.
Residual product should be removed from test areas after the final sample collection is 
complete using alcohol wipes.
8.
Record the subject number on the package label and retain for inventory purposes. Discard 
used applicators.


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Treatment Code: S (Sterile 0.9% saline – 20 mL bottle, with sponge applicator)
1. Remove petri plate from sleeve. Place lid sterile side up on bench. 
2. Pour 20 mL sterile saline into lid.
3. Aseptically remove applicator from sterile packaging.
4. Holding applicator handle place one side of sponge into saline, allowing fluid to flow into 
sponge. Gently press sponge against lid until saturated. Flip sponge and repeat, ensuring both 
sides of sponge are completely saturated with fluid.
5. Apply the product with repeated back-and-forth strokes for 2 minutes on the groin, flipping 
applicator as needed to ensure the test area remains wet during product application.
6. Allow the test area to dry for 3 minutes.
7. Contact time begins after step 6.
8. Record the subject number on the package label and retain for inventory purposes. Discard 
used applicators.


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14.3 Confirmation of Release & Receipt of Clinical Supplies
CONFIRMATION OF RELEASE & RECEIPT OF CLINICAL SUPPLIES
Investigator: M. Hamid Bashir, MD
Study No:  EM-05-014264, MBT #109-296
Test Site:  Microbac
Qty
Item Name
ID/Lot Number
Exp. Date
Supplies Released to Site by:   _________________________________
Monitor’s Signature
Supplies Sent to Site (Date): ___________________________________
Supplies Checked and Verified by:  ______________________________
Signature
Date
   ______________________________
Print Name, Title
Once the supplies have been verified and this form is signed / dated, please scan and email a 
copy to Linda Olson at lkolson2@mmm.com.


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14.4 Study Product Disposition Form
As an investigator, you are required to record disposition of clinical study products. This form is 
supplied for your convenience in fulfilling this obligation. Use one form for each study product.
Study Number: EM-05-014264, MBT #109-296
Protocol Title: Assessment of the antimicrobial efficacy of 3MTM SoluPrepTM Preoperative Skin 
Preparation against resident human skin flora on the inguinal region
Investigator: M. Hamid Bashir, MD
Investigator Site: Microbac
Investigational Material 
ID:
Date Received:
Quantity
Received:
Lot Number/ 
Serial Number:
Date Returned 
to Sponsor:
Date 
Dispensed/Distributed
Subject Number
Quantity Dispensed
Quantity Remaining


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14.5 Subject Instructions
Subject Instructions during Washout, Screening and Treatment Phases
The instructions below are to be followed until the completion of the study.
1. Use only the soap provided for all sponge-bathing and hand-washing.
2. Use only the shampoo provided when washing your hair.
3. Do not use antiperspirants or deodorants (other than those provided to you in the kit), 
lotions, colognes, perfumes, after shaves or powders.
4. Do not come in contact with solvents, acids, bases, fabric softener-treated clothing or 
other household chemicals on the upper thigh body regions.
5. Do not swim in chemically treated pools or bathe in hot tubs, whirlpools or spas.
6. Do not use tanning beds.
7. Do not shave or use depilatories or hot waxes on the upper thigh body regions. If hair is 
present, allow study staff to clip hair at a designated time.
8. Do not apply any medicated creams or ointments to any area of your skin, nor should you 
take any antibiotics. If antibiotics are necessary due to illness, please report this to M. 
Hamid Bashir, MD at 703-925-0100 or 571-435-6371 immediately.
9. Do not use any topical or oral antihistamines within 48 hours of or during your Treatment 
Day Visit (eg, Claritin®, Benadryl®, Zyrtec®, Singulair®, Cromolyn, Nyquil™, 
Tylenol® PM).
DO NOT BATHE OR SHOWER IN THE 72-HOUR PERIOD BEFORE YOUR 
SCREENING VISIT (A sponge-bath may be taken but avoid the areas of the upper thigh.)
Clipping visit (if necessary):__________________________(Date)
Screening visit :____________________________________(Date)
You will be contacted by telephone on __________________to let you know if you have 
been selected to complete the study or if you have been eliminated. Please continue to use 
your kit products until you have been eliminated or complete the study.
If you are selected to complete the study:
DO NOT BATHE OR SHOWER IN THE 72-HOUR PERIOD BEFORE YOUR 
TREATMENT DAY VISIT (A sponge-bath may be taken but avoid the areas of the upper 
thigh.)
Clipping visit (if necessary):__________________________(Date)
Application visit :__________________________________(Date)
Return to the test facility for the 6 hour ± 30-minute skin sampling (as scheduled). Avoid 
sweating or getting the test sites wet during this time period.


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If you have questions about this study or in case of emergency, contact M. Hamid Bashir, 
MD, Principal Investigator, at 703-925-0100 at any time during business hours or 
571-435-6371 after business hours.


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14.6 Elements of Informed Consent
These elements of consent should be included as applicable to the study being conducted.
1. Statement that the study involves research.
2. Purpose(s) of the research.
3. Expected duration of subject’s participation.
4. Procedures to be followed and identification of any procedures that are experimental.
5. A description of any reasonable foreseeable risks or discomforts to the subject.
a) Risks/discomforts from study procedures.
b) Foreseeable risks associated with the investigational product, which include adverse 
experiences listed in the Investigator’s Brochure or package insert.
6. A description of any benefits to the subject or to others which may reasonably be expected 
from the research.
7. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might 
be advantageous to the subject.
8. Extent to which confidentiality of records identifying subject will be maintained.
a) Possibility that representatives of 3M and the FDA may inspect and make copies of the 
records.
b) Suggested text: “I understand that, at anytime, an agent of 3M may also review any 
hospital, physician, or insurance billing or any other costs which relate to therapy 
incurred as a direct result of my participating in this study.
9. An explanation as to whether any compensation or medical treatments are available if injury 
occurs for research involving more than minimal risk. The explanation should involve a 
description of the compensation or treatment available or a statement describing where 
further information may be obtained.
10. Whom to contact for answers to pertinent questions about research and research subject’s 
rights.
11. Whom to contact in the event of research-related injury to the subject.
12. Participation is voluntary:
a) Refusal to participate will involve no penalty or loss of benefits to which subject is 
otherwise entitled.
b) Subject may discontinue participation at any time without penalty or loss of benefit to 
which subject is otherwise entitled.


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ADDITIONAL ELEMENTS OF CONSENT
When appropriate, one or more of the following elements of information shall also be provided 
to each subject.
1. A statement that the particular treatment or procedure may involve risks to the subject (or 
embryo or fetus, if subject became pregnant) which are currently unforeseeable.
2. Anticipated circumstances under which subject’s participation may be terminated by the 
Investigator without regard to subject’s consent.
3. Any additional costs to the subject that may result from participation in the research.
4. A statement explaining the consequences of subject’s decision to withdraw during the course 
of the research which may relate to subject’s willingness to continue participation will be 
provided to the subject.
5. A statement that significant new findings developed during the course of the research which 
may relate to subject’s willingness to continue participation will be provided to the subject.
6. Approximate number of subjects involved in the study.
Nothing in these regulations is intended to limit the authority of a physician to provide 
emergency medical care to the extent the physician is permitted to do so under applicable 
federal, state, or local laws.
Informed consent allows the subject to fully understand his/her participation and serves to 
protect the Investigator and Sponsor from potential negligence claims. A fully informed subject 
is the best protection against such claims.
The informed consent requirements in these regulations are not intended to preempt any 
applicable federal, state, or local laws that require additional information be disclosed for 
informed consent to be legally effective. Some states, such as California and Oregon, require 
further action on the Investigator’s part concerning subject consent.


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14.7 Test Site Diagram
Follow the randomization schedule for each subject for the exact placement of test materials.


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14.8 Skin Irritation Rating Scale
a = A rating of 3 on the skin irritation scale will be recorded as an Adverse Event.
Skin Irritation Rating Scale (Modified Draize)
Condition
Rating Description
Erythema
0
No reaction
1
Mild and/or transient redness limited to sensitive area
2
Moderate redness persisting over much of the product-exposed area
3a
Severe redness extending over most or all of the product-exposed area
Edema
0
No reaction
1
Mild and/or transient swelling limited to sensitive area
2
Moderate swelling persisting over much of the product-exposed area
3a
Severe swelling extending over most or all of the product-exposed area
Rash
0
No reaction
1
Mild and/or transient rash limited to sensitive area
2
Moderate rash persisting over much of the product-exposed area
3a
Severe rash extending over most or all of the product-exposed area
Dryness
0
No reaction
1
Mild and/or transient dryness, limited to sensitive area
2
Moderate dryness persisting over much of the product-exposed area
3a
Severe dryness extending over most of the product-exposed area


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14.9 Protocol for Neutralization Validation
14.9.1 Background
In order to accurately assess the efficacy of an antimicrobial product, it is necessary to 
completely inactivate the antimicrobial agent at the time point being evaluated. Inadequate 
neutralization will allow killing or inhibition of the microorganisms to continue beyond the 
specified contact time, resulting in an overestimation of antimicrobial activity.
Standard sampling solution (SSS) is a buffered detergent solution that is commonly used in 
studies where microbial sampling of skin is conducted. Neutralizers have been added to 
inactivate the antimicrobial, CHG, present in the investigational and marketed active study 
products. Modified Sampling Solution (MSS) is a 1 to 6 ratio of Triacetin to SSS. Triacetin is a 
fully saturated triglyceride, commonly used as an emollient, and is required to dissolve the film 
formed by SoluPrep FF. The MSS is used to neutralize SoluPrep and SoluPrep FF. The 
effectiveness and nontoxicity of these neutralizer systems must be assessed to demonstrate that 
there is no effect on the growth of microorganisms and that the antimicrobial ingredient is 
inactivated.
The density of normal human skin flora generally ranges from 102 to 108 CFU/cm2 depending on 
the body site. However, since significant neutralizer or toxic effects are more easily detected at a 
lower cell density, the efficacy and toxicity of these neutralizers will be assessed against a lower 
bacterial concentration. 
This is an in vivo test where the active study products are applied to the skin using the same 
application instructions used for the inguinal region during the study (Appendix 14.2). Scrub cup 
samples are collected and inoculated with low levels of methicillin-resistant Staphylococcus 
epidermidis (MRSE) or methicillin-sensitive Staphylococcus epidermidis (MSSE). Two contact 
times after inoculation will be evaluated: immediately (<1 minute) and 40 minutes (to test for 
residual antimicrobial activity between sample collection and the time of plating).
14.9.2 Objective
The objective of this assay is to determine the ability of the sampling solutions to completely 
neutralize the active ingredients contained in SoluPrep and SoluPrep FF when applied to the 
abdomen of test subjects without exhibiting toxicity to the test organisms.
14.9.3 Subject Entry Criteria
Six subjects will participate in this study. Subjects must meet the inclusion and exclusion criteria 
in Sections 4.1 and 4.2 of the protocol to which this neutralizer validation is attached, except for 
the baseline bacterial count, the 72-hour exclusion from showering/bathing and the length of the 
washout period. The neutralization subjects do not require a minimum baseline count and they 
only need to avoid topical and systemic antimicrobials for 7 days (not 14 days) prior to 


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Treatment Day. Subjects will be asked to provide information on demographics and 
inclusion/exclusion criteria and sign the Informed Consent and Authorization Forms before 
beginning the 7-day washout period. When subjects return to begin their participation in the 
study they will again be asked to provide information relative to inclusion/exclusion criteria. If 
they meet all inclusion/exclusion criteria, they may be enrolled. These subjects will be identified 
by the letter “N” for neutralization and a subject number starting with 001.
Each subject will receive both active study products (SoluPrep and SoluPrep FF), which will be 
applied to 2 separate test areas on the abdomen. One area will be located on each side of the 
body as indicated in the diagram below.
Neutralization Test Area Diagram
14.9.4 Test Organism
The test organisms for this study are methicillin-resistant Staphylococcus epidermidis, ATCC 
51625, and methicillin-sensitive Staphylococcus epidermidis, ATCC 12228.
14.9.5 Study Products
●
SoluPrep, 10.5-mL, tinted
●
SoluPrep FF, 10.5-mL, tinted


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14.9.6 Materials, Supplies and Equipment
●
Product kits (toiletry items to be used by subjects during study)
●
Subject Informed Consent / Authorization forms, IRB-approved
●
Standard Sampling Solution (SSS), 75mM phosphate buffer (0.04% monobasic potassium 
phosphate, and 1.01% dibasic sodium phosphate) containing 0.1% Triton® X-100, 0.3% 
lecithin, 3.0% polyoxyethylene sorbitan monooleate (Tween® 80), and 1.0% Tamol™ SN; 
pH 7.9 + 0.1, sterile
●
Triacetin (provided by sponsor)
●
Butterfield’s sterile phosphate buffered water1 (PBW), 312 μM KH2PO4, pH 7.2 ± 0.1
●
70% Isopropyl alcohol (w/w) swabs/wipes
●
High-purity deionized water, sterile
●
Trypticase soy broth (TSB)
●
Trypticase soy agar (TSA)
●
Trypticase soy agar containing 0.5% Tween 80 and 0.07% lecithin (TSA+N)
●
Methicillin-resistant Staphylococcus epidermidis (MRSE), ATCC 51625
●
Methicillin-sensitive Staphylococcus epidermidis (MSSE), ATCC 12228
●
Alcohol wipes
●
Transfer pipettes, polyethylene, sterile
●
Serological pipettes, 1 mL, 2 mL, and 10 mL, sterile
●
Pipettor, calibrated to accurately deliver volumes of 0.5 mL, 2.5 mL and 3.0 mL, and sterile 
tips
●
Pipetting, calibrated to accurately deliver 20-200 µL, and sterile tips
●
Tubes with sealable caps, polypropylene or glass, sterile
●
Petri dishes, 100 mm, sterile
●
Gloves, sterile
●
Marking templates, 1.5” x 5”, sterile (for marking test sites)
●
Non-toxic marking pen (Sharpie or equivalent), sterile (Note: Do not use markers containing 
crystal violet)
●
Scrub cups (2.20 cm I.D., 3.80 cm2), sterile
●
Teflon or rubber policemen, sterile
●
Timers or stopwatches
●
Pipet Aid or similar apparatus
●
Vortex mixer
●
Water bath (45 ± 2C)
●
Incubator (30 ± 2C)
●
Surgical clippers with blades
14.9.7 Study Procedures
14.9.7.1 Preparation of Inoculum
Prepare an overnight (24 + 4 hours) broth culture of each of the test organisms at 35 + 2oC in 
TSB, to contain approximately 108 – 109 CFU/mL.


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Dilute the overnight cultures with PBW to achieve an appropriate concentration (approximately 
104 CFU/mL) for inoculation of the test samples. The density of the test inocula must be verified 
by direct plating at the beginning and end of the study.
14.9.7.2 Preparation of Test Areas and Post-Prep Sampling
Neutralization samples will be evaluated on the abdomen. The test areas on each subject’s 
abdomen will be assigned according to a computer-generated randomization schedule to receive 
either the investigational product on the left and the active control on the right or the 
investigational product on the right and the active control on the left. The subject number, 
location of the product application, location of the sites sampled within the test area, and the time 
of sample collection will be documented. Each subject will be treated with both study products, 
one in each test area.
Abdominal test areas will be marked using a sterile 1.5” x 5” template. One 1.5” x 5” area will 
be delineated on each side of the body with each area containing two 1” x 1” sampling sites (one 
sampling site will be used for each test organism) to yield 4 sampling sites for each subject (see 
neutralization test area diagram in Section 14.9.3 of the neutralization validation). One tube from 
each test area will be inoculated with MRSE and the other will be inoculated with MSSE.
After the test areas are marked, each area will be prepped with three 70% isopropyl alcohol 
swabs for a total of 1 minute and allowed to dry for 3 minutes.
Each test area will be treated with 1 of the 2 study products, according to the instructions for the 
inguinal region provided in Appendix 14.2 of the protocol to which this neutralizer validation is 
attached.
Samples will be collected, using the scrub cup technique, at 10 minutes (30 sec.) post-prep. 
Post-prep timing begins upon completion of study product application, including the 3-minute 
drying time. For the two sites within each 1.5” x 5” area; the samples may be collected 
simultaneously by two technicians. The sampling technique is described in Section 5.3.4.1 of the 
protocol to which this neutralizer validation is attached.
Residual product should be removed from test areas after sample collection is complete using 
alcohol wipes.
Each pooled sample (~6 mL) will be capped tightly and pulsed 3 times on a vortex mixer. 
Sample tubes will be sonicated 2 minutes followed by vortex mixing for 30 seconds. Five mL 
will be transferred to a clean tube and immediately inoculated with 100 μL of the appropriate 
diluted inoculum (Section 14.9.7.1 of the neutralization validation). This will yield an organism 
concentration of ~20 – 200 CFU/mL.


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Immediately (<1 minute) and at 40 minutes (+ 2 minutes) post-inoculation, 1.0-mL aliquots of 
the inoculated samples will be pour-plated in triplicate using TSA+N. Plates will be incubated 
inverted at 35 + 2oC for 48 + 4 hours.
14.9.7.3 Numbers Control and Toxicity Control
This testing will be performed in triplicate.
Numbers Control (NC):
Add 100 uL of the appropriate diluted inoculum to a tube containing 5 mL PBW to yield final 
inoculum concentrations of ~20-200 CFU/mL. Sonicate 2 minutes followed by vortex mixing for 
30 seconds. Pour-plate triplicate 1.0 mL aliquots immediately (<1 minute) and 40 minutes (+ 2 
minutes) post-inoculation in the same manner as 14.9.7.2, except using TSA without 
neutralizers.
Toxicity Control (TC-MSS):
Add 1.0 mL Triacetin to 5.0 mL SSS and pulse 3 times on a vortex mixer followed by a 2-minute 
sonication and 30-second vortex. Transfer 5 mL to a clean tube. Add 100 uL of the appropriate 
diluted inoculum to the 5-mL tube to yield final inoculum concentrations of ~20-200 CFU/mL. 
Pour-plate triplicate 1.0 mL aliquots immediately (<1 minute) and 40 minutes (+ 2 minutes) 
post-inoculation in the same manner as 14.9.7.2.
These controls will provide assurance that the test organisms are not adversely affected by the 
treatments or the sampling procedures.
14.9.7.4 Enumeration
Plates may be refrigerated for up to 72 hours prior to counting. Enumerate plates and calculate 
CFU/mL for each sample. Convert data to log10 CFU/mL.
14.9.8 Control of Bias
Bias is controlled by internal controls and triplicate plating.
14.9.9 Data Evaluation
Recovery for each of the samples will be expressed as Log10 CFU/mL.
Neutralizer Effectiveness: 
If the mean log10 CFU/mL of the sample is not more than 0.3 log10 less than the mean log10
CFU/mL of the NC, the neutralization will be considered effective.

Mean log10 CFU/mL from NC – Mean log10 CFU/mL from sample (use corresponding time 
points)


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Neutralizer Toxicity:
If the mean log10 CFU/mL of the TC is not more than 0.3 log10 less than the mean log10 CFU/mL 
of the NC, the sampling solutions will be considered non-toxic.

Mean log10 CFU/mL from NC − Mean log10 CFU/mL from TC (use corresponding time 
points).

SAP_001.pdf: 
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STATISTICAL ANALYSIS PLAN
Assessment of the Antimicrobial Efficacy of 3M™ SoluPrepTM
Preoperative Skin Preparation against Resident Human Skin Flora on 
the Inguinal Region
Clinical Study Number:  EM-05-014624
Microbac
Prepared by
Dan J. Morse
3M Project Statistician
Approvers
Do not change the table below as it is automatically populated by the system when the 
document is released. 
Signer
Role
Date Signed
US233115:Olson Linda K
Clinical
March 31, 2020 09:53:27 AM CDT
US314980:Meeter Carol A
Clinical
March 31, 2020 09:37:26 AM CDT
NCT #: NCT04756154


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Contents
1.
INTRODUCTION..................................................................................................................3
2.
STUDY OBJECTIVES ...........................................................................................................3
2.1
Primary Objective ..........................................................................................................3
2.2
Secondary Objectives......................................................................................................3
3.
INVESTIGATIONAL PLAN...................................................................................................4
3.1
Study Design.................................................................................................................4
3.2
Randomization...............................................................................................................4
3.3
Blinding........................................................................................................................6
4.
EFFICACY ENDPOINTS .......................................................................................................7
5.
ANALYSIS POPULATIONS ..................................................................................................7
5.1
Safety Population...........................................................................................................7
5.2
Modified Intent-To-Treat Population (MITT).....................................................................8
5.3
Per-Protocol Population ..................................................................................................8
6.1
Interim Analysis...........................................................................................................10
6.2
Determination of Sample Size........................................................................................10
6.3
Handling of Dropouts and Missing Data..........................................................................11
6.4
Validation Plan ............................................................................................................11
7.1
Subject Disposition.......................................................................................................12
7.2
Protocol Deviations......................................................................................................12
7.3
Baseline and Demographic Characteristics.......................................................................12
7.4
Treatment Duration and Compliance...............................................................................12
8.1
Primary Efficacy Analysis.............................................................................................13
8.2
Secondary Efficacy Analysis..........................................................................................14
9.1
Adverse Events............................................................................................................15
9.2
Other Safety Variables..................................................................................................15
APPENDIX................................................................................................................................16
LIST OF ABBREVIATIONS AND DEFINITIONS .....................................................................16


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1. INTRODUCTION
The text in the Statistical Analysis Plan (SAP) reflects the analysis methods planned as of 
the date of the SAP. It contains more details for the analyses mentioned in the Clinical 
Investigational Plan (CIP) and may be amended to reflect any additional analyses planned 
prior to unblinding the data.  
2. STUDY OBJECTIVES
2.1 Primary Objective
The primary objective of this study is to evaluate the antimicrobial efficacy of 3M™ 
SoluPrepTM Preoperative Skin Preparation (SoluPrep) by demonstrating non-inferiority to 
3M™ SoluPrepTM Film-Forming Sterile Surgical Solution (SoluPrep FF), an FDA-
approved active control, with a 0.5 margin (log10 scale), and demonstrating a superiority
to saline, the negative control, with a superiority margin of 1.2 log10/cm2. In addition, 
both active products should demonstrate persistence of effect where the 6-hour post-
treatment measurement is lower than or equal to the observed study day baseline 
measurement for 100% of the subjects. 
2.2 Secondary Objectives
Safety will also be evaluated based on the incidence of adverse events reported during the 
study and assessment of skin irritation ratings.


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3. INVESTIGATIONAL PLAN
3.1 Study Design
This is a randomized, controlled, third-party blind, single-center study in healthy 
volunteers where each subject receives 2 of the 3 possible study products on the groin. 
The study staff performing the bacterial enumeration and the statistician performing the 
analysis will be blinded to the study products.
3.2 Randomization
The left and right test areas on the subject’s inguinal region will be assigned according to 
a computer-generated randomization schedule where each will receive 1 of the 3 study 
products (see Table 1). Treatment randomization will be balanced between left and right 
sides. There are 3 different possible combinations of treatments. These are shown below 
in Table 2. 
To provide enough subjects to meet study objectives, the treatment combinations will be 
randomized in a 6:1:1 ratio for combinations 1 through 3, respectively, at the single 
recruiting clinical facility. The details of block size will be documented in the final study 
report.  
Baseline and post-prep samplings at 10 minutes and 6 hours will be randomized to three 
sites within each test area. The same test site randomization will be used on the left and 
right sides of a subject’s body to reduce the possibility of sampling errors.
The Investigator is responsible for ensuring that the study randomization is followed. 
Randomization envelopes will be provided to the study site.


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Table 1 Study Products
Treatment 
Code
Study Product
Description
SP
SoluPrep 
Contains 2% w/v chlorhexidine gluconate (CHG) and 70% v/v 
isopropyl alcohol (IPA). 10.5-mL applicator, tinted.
SPFF
SoluPrep FF
Contains 2% w/v chlorhexidine gluconate (CHG) and 70% v/v 
isopropyl alcohol (IPA) in combination with an acrylate 
copolymer. 10.5-mL applicator, tinted.
S
Saline
Negative control. Sterile 0.9% saline. 20-mL bottle.
Table 2 Subject Treatments
Treatment 
Combination
Left and Right Treatment
1
SoluPrep 10.5-mL and SoluPrep FF 10.5-mL (SP + SPFF)
2
SoluPrep 10.5-mL and saline (SP + S)
3
SoluPrep FF 10.5-mL and saline (SPFF + S)
Randomization Plan:
A 3M statistician not assigned to the project will develop a randomization program and 
generate the randomization code list. The code list will include randomization number, 
left side treatment, right side treatment, baseline sample site, 10-minute sample site and 
6-hour sample site. The randomization assignments will be printed and inserted into 
security envelopes then tightly sealed.
The Data Manager will strip the treatment assignment from the programs that are used to 
download the data from Clindex®. This will keep the statistician assigned to the study 
blinded until data lock. 


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Randomization Process:
For each eligible subject to be randomized, the investigator or designee will do the 
following:
●
Retrieve a randomization envelope with smallest available randomization envelop 
number.
●
Record randomization number onto a Data Collection Sheet (DCS) and/or the 
electronic Case Report Form (eCRF).
●
When the treatments are applied, record onto a DCS and/or the eCRF; left side 
treatment applied, right side treatment applied, baseline sample site, 10-minute 
sample site and 6-hour sample site.
●
Subjects will continue to be randomized until a minimum of 100 observations (with a 
baseline that meets the Treatment Day requirement) from each of the active 
treatments and 30 observations from the saline control (with a baseline that meets the 
Treatment Day requirement) have been collected.
3.3 Blinding 
The study products cannot be blinded from the Investigator or study staff performing the 
product application, sample collection and skin assessment due to the obvious differences 
in applicator design, color, and other physical characteristics. However, the study staff 
performing the bacterial enumeration will not be involved in the study product 
application or the collection of samples and, therefore, will be blinded to the study 
products. The statistician performing the analysis will also be blinded.
The biostatistician will remain blinded to treatment assignment before database lock and 
final study data analysis. The treatment assignments will be removed from the relevant
databases and random treatment assignments given to each subject. The final data review 


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and data classification meeting will be conducted before data lock and statistical
programming will occur using the dummy treatment assignments.
4. EFFICACY ENDPOINTS

Non-inferiority of the investigational product to the FDA-approved active control 
for log10/cm2 recovery of skin flora relative to Treatment Day baseline log10/cm2
on the inguinal region at 10 minutes following application. Non-inferiority is based 
on a non-inferiority margin of 0.5 log10/cm2.

Superiority of the active products to the negative control for log10/cm2 recovery of 
skin flora relative to Treatment Day baseline log10/cm2 on the inguinal region at 10 
minutes following application. A superiority margin of 1.2 log10/cm2 is used.

Number of observations for which the log10/cm2 recovery of skin flora on the 
inguinal region at 6 hours following application of the study products is higher 
than treatment day log10/cm2 baseline skin flora.

The principal measure of safety will be the incidence of adverse events reported 
during the study and a summary of the skin irritation rating scores. A skin irritation 
rating of 3 post-treatment in any category (erythema, edema, rash and dryness)
represents significant irritation and qualifies as an Adverse Event.
5. ANALYSIS POPULATIONS
5.1 Safety Population
The intent-to-treat (ITT) data set will be the primary data set for safety and will include 
all subjects randomized to a treatment group. Subjects will be analyzed in the group to 


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which they were randomly assigned.
5.2 Modified Intent-To-Treat Population (MITT)
A MITT data set will be used for primary efficacy analyses. All subjects who meet 
baseline requirements on a bilateral side will be included in the analysis for that bilateral 
side. However, the primary analyses involve a linear regression at the 10-minute post-
treatment time point and calculation of return to baseline at 6 hours. These analyses 
require both baseline and 10-minute recovery for treatment effect or baseline and 6-hour 
recovery data for return to baseline percentage calculation. There is no scientific basis for 
imputation of these missing values.  Fortunately, missing values are not expected.  There 
was no missing data for the 2346 microbiological samples taken in the pivotal study 
conducted at this site for SoluPrep FF.  The exclusion of subjects who do not meet 
baseline requirements and who are missing recovery data at either the 10-minute 
sampling time point or the 6-hour sampling time point (post-treatment) times makes this 
data set a modified intent-to-treat data set.
The baseline bacterial count requirements are in the range of 5.00 to 7.50 log10/cm2 on 
the groin. The acceptability of each bilateral baseline will be assessed separately for 
inclusion in the study.
5.3 Per-Protocol Population
A second per-protocol (PP) data set will be defined excluding any subjects with major 
deviations including lack of compliance 
A treatment side will be excluded from the modified intent-to-treat population that has 
one of the following:

A treatment side with a compromised dressing at 6 hours

A subject who was not compliant to study requirements during the time between 
the 10 minute and 6-hour sample collection


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A treatment side might also be excluded for scrub time or sample times outside of the 
approved window.
All deviations not captured above that will result in exclusion from the PP analysis will 
be defined and justified in a blinded fashion. In addition, documentation will be made of 
these data classification decisions prior to data lock.  
6. GENERAL STATISTICAL CONSIDERATIONS
All statistical analyses will be performed using SAS version 9.4 or above (SAS Institute, 
Cary, NC).  Any changes to the methods proposed in this SAP will be documented in the 
“Changes to Planned Analyses” section of the final clinical investigation report.
Reporting Precision:

Age will be reported as whole years.

Log10 CFU/cm2 and reduction log10 will be reported to 2 decimal places.

Means and medians will be presented to one more degree of precision than the 
raw data; except when specified otherwise.

Standard deviations and standard errors will be presented to two more degrees of 
precision than the raw data except when otherwise specified.

For log recovery and log reduction, means and medians will be reported to 2
decimal places and the standard deviation to 3 decimal places. 

Minimums and maximums will be presented to the same degree of precision as 
the raw data.

Confidence limit boundaries will be presented to one more degree of precision 
than the raw data.

P-values will be rounded to 3 decimal places and presented as 0.xxx. P-values 
smaller than 0.001 will be presented as “<0.001.”  P-values greater than 0.999 
will be presented as “>.999”.


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
Fractional numeric values will be presented with a zero to the left of the decimal 
point (for example, 0.12 – 0.30).

Percentages (such as return to baseline percentage) will be presented to one 
decimal place.
Other Data Handling Issues:

On treatment day, when a plate at the lowest dilution (highest concentration of 
bacteria) has no observed colonies, a value of “1” will be used, consistent with 
standard microbiology. 
Process time limits:

10-minute post-prep sampling time (post-prep and 3-minute dry) 10 minutes + 30 
second.

6-hour post-prep sampling time (post-prep and 3-minute dry) 6 hours + 30 
minutes.

The microbiological samples must be plated within 30 minutes of sample 
collection. 
6.1 Interim Analysis  
No interim analysis will be conducted.
6.2 Determination of Sample Size
The Final Monograph (21 CFR Part 310 Safety and Effectiveness of Health Care 
Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use) 
calls for a minimum of 100 observations per treatment. A standard deviation of 1.0 
log10/cm2 was observed in study EM-05-012760. One-hundred subjects per treatment arm 


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provides 94% power using a non-inferiority margin of 0.5 log10/cm2 with a 1-sided alpha 
of 0.025.
In the same study, a superiority to the negative control was observed to be approximately 
2.5 log10/cm2, with a lower 95% confidence bound of 2.26 log10/cm2. A sample size of 30 
for the negative control will ensure that the mean for log10/cm2 reduction of skin flora 
relative to Treatment Day baseline will be normally distributed. With 100 observations 
for the active products and 30 observations for the negative control, the mean observed 
difference must be greater than 1.62 log10/cm2 for the lower 95% confidence bound to be 
greater than 1.2 log10/cm2. At these sample sizes and the lower 95% confidence bound of 
2.26 log10/cm2, there is 79% power to show superiority to the negative control with a 1-
sided alpha of 0.025.
6.3 Handling of Dropouts and Missing Data
There will be no imputation of microbiological data because there is no scientific basis 
for such imputation.
6.4 Validation Plan
Programs were developed for the pivotal studies for SoluPrep FF.  Programs were written 
by both 3M and the Contract Research Organization (CRO) hired by 3M, yielding 
identical results.  The current study is very similar to those studies and the previously 
developed programs can be used with minor modifications.   Validation of statistical 
programs and output will be through an independent review of the code and output by a 
statistician not assigned to this study.  
7. SUMMARY OF STUDY POPULATION 


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7.1 Subject Disposition
Subject enrollment, including number of subjects screened, number of subjects 
randomized and the reasons for screen failures, will be summarized by treatment group 
and overall.
Subject disposition, including the number and percentage of subjects included in each 
analysis data set (ITT, MITT or PP), as well as reasons for exclusion from the PP data 
set, will be summarized by treatment group and overall. 
Study completion status (completed the study or discontinued early from the study), as 
well as the primary reason for study discontinuation, will be summarized by treatment 
group and overall.
7.2 Protocol Deviations
Protocol deviations are any departure from the protocol.  Protocol deviations that affect 
the evaluability of subjects will be reviewed during a blinded review process and 
documented before data lock and study analysis.  Deviations will be summarized by 
categories, treatment group and overall.  Listing of protocol deviations will also be 
provided.
7.3 Baseline and Demographic Characteristics
Descriptive summary statistics will be provided for demographic characteristics for each 
treatment group and overall.  For continuous variables, the number of subjects, mean, 
standard deviation, median, minimum and maximum will be provided.  For categorical 
variables, the number and percentage of subjects in each demographic category will be 
summarized.  
7.4 Treatment Duration and Compliance


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Since the treatments will be administered by study staff, subject compliance with respect 
to treatment compliance is not an issue in this study. Treatment duration is 6-hours, + 30 
minutes.  Therefore, treatment exposure and compliance will not be summarized or listed.
The subjects may leave the facility after the 10-minute post treatment microbial samples 
are taken.  They will be queried before the 6-hour sample is taken to determine if they have 
followed the instructions to avoid showering, tub-bathing, swimming, vigorous physical 
activity that may cause sweating, and any other activity that may compromise the integrity 
of the test sites.
8. EFFICACY ANALYSIS
8.1 Primary Efficacy Analysis 
The average treatment effect (ATE) for the investigational product will be estimated 
using a linear regression of the 10-minute post-treatment bacterial count (log10 scale) on 
the additive effect of a treatment indicator and the baseline measurement (log10 scale). 
The lower bound of the 95% confidence interval for the additive treatment effect must 
not include the investigational product being more than 0.5 log10/cm2 lower than the 
positive control.
The ATE of the test product compared to the negative control is estimated as the contrast 
of treatment effect of negative control minus the treatment effect of the test drug in the 
linear regression. Likewise, the ATE of the active control compared to the test product is 
estimated as the contrast of treatment effect of test product minus the treatment effect of 
the active control in the linear regression. Superiority to negative control uses a margin of 
1.2 log10/cm2, which would be demonstrated by a lower bound of the 95% confidence 
interval for the contrast to exceed 1.2 log10/cm2.
An example code for the analyses specified above is shown below:
Proc Mixed data=D_14624.LogMicro;
Class Treatment;


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Where Timepoint=1 and Treatment in (1 2);
Model LogRecovery=Treatment LogBaseline/ddfm=kr;
Lsmeans Treatment/cl;
Run;
The percent of samples for which the 6-hours post treatment recovery is lower than the 
baseline recovery will be calculated by active product. Thus, if log10 reduction is >0 the 
sample has not returned to baseline.  The Final Monograph requires that these 
percentages be 100.
An example code for percentage return to baseline is shown below:
Proc Format;
value Return              -5-0='Returned to Baseline'
0.0001-8='Did not Return to Baseline';
run;
Proc Freq data=D_14624.LogMicro;
Where Timepoint=2;
Tables LogReduction*Treatment/nopercent norow;
format LogReduction return.;
Run;
8.2 Secondary Efficacy Analysis 
Summary tables will be produced by treatment for log10/cm2 baseline skin flora, 
log10/cm2 recovery of skin flora, and log10/cm2 reduction of skin flora relative to 
Treatment Day baseline log10/cm2 on the inguinal region at 10 minutes and 6 hours 
following application of the study materials. The tables will include number, mean, 
standard deviation, minimum and maximum.


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9. SAFETY ANALYSIS
Adverse events and skin irritation scores will be summarized by treatment.  
9.1 Adverse Events
All adverse events (AEs) occurring after initiation of study treatment (treatment emergent 
AEs) will be summarized by severity, relatedness, overall and by treatment group.  AEs 
occurring during the screening period will be summarized separately. All AEs will be 
classified using the MedDRA dictionary.
All verbatim descriptions will be listed for all AEs, along with information regarding 
onset, duration, severity, relationship to treatment, and action taken.
Serious adverse events will be summarized and presented according to nature, time to 
onset, duration, relationship to treatment and outcome.  
A Fisher’s Exact test will be carried out to compare each safety parameter between the 
treatment groups.
9.2 Other Safety Variables
Skin irritation scores will be summarized by treatment.


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APPENDIX
LIST OF ABBREVIATIONS AND DEFINITIONS
AE
Adverse event
ATE
Average Treatment Effect
CFU
Colony forming units
CHG
Chlorhexidine gluconate
CRO
Contract Research Organization
DCS
Data Collection Sheet
eCRF
Electronic Case Report Form
EDC
Electronic data capture
FM
Final Monograph
IPA
Isopropyl alcohol
ITT
Intent to Treat
MITT
Modified Intent to Treat
PP
Per Protocol
Revision History
Revision
Details:
1
To establish statistical analysis plan before study enrollment.