Evaluation of the Antimicrobial Effectiveness of CHG/IPA in Healthy Volunteers
Conditions: Microbial Colonization
Sponsor: Becton, Dickinson and Company

CCD 
CCD-5115.T01 Protocol Template 
Revision 05 
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BD Protocol #: MPS-17IPVSS02 
Eurofins Evic Romania 
Study #: ER18/149 
Protocol Title: A Randomized, Single-Center, Partially Blinded, Evaluation of the 
Time-Dependent Antimicrobial Effectiveness of Swabsticks 
Impregnated with 2% (w/v) Chlorhexidine Gluconate in 70% (v/v) 
Isopropyl Alcohol in Healthy Volunteers 
Current Version Version 2.0 – 06 May 2019 (Amendment 1) 
Version History Version 2.0 – 06 May 2019 (Amendment 1) 
Version - 1.0 26 February 2019 (Original) 
Sponsor BD – Becton, Dickinson & Company 
75 N. Fairway Dr., 
Vernon Hills, 
IL 60061 
Sponsor Medical 
Monitor VP, Medical Affairs, Interventional Segment 
The product information and data disclosed through this protocol are confidential and may not be disclosed without 
prior written consent of Becton, Dickinson and Company. 
This study will be performed in accordance with all stipulations of the protocol and in compliance with all applicable 
BD Policies and Procedures.  This study will be conducted in accordance with the ethical principles that originate 
from the Declaration of Helsinki and the Belmont Report. Study conduct will comply with applicable regulatory 
requirements and the Good Clinical Practice guidelines set forth by the International Conference on Harmonization 
(ICH-E6). 
All Study Product(s) used in this study should be considered to be for investigational use only. 
NCT Number: [NCT04035161] (Number added post-approval per CT.gov requirement)

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INVESTIGATOR SIGNATURE PAGE 
 
Investigator 
Rozalia Olsavszky, MD 
Dermatologist 
 
64-66, Marasesti Boulevard 
040256 - Bucharest, Romania 
Investigational Site 
EUROFINS EVIC PRODUCT TESTING 
ROMANIA S.R.L. 
 
64-66, Marasesti Boulevard 
040256 - Bucharest, Romania 
 
I have read this protocol and agree to conduct this study in accordance with all stipulations of the protocol 
and in compliance with all applicable Good Clinical Practices and regulations. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Signature of Investigator 
 
 
 
 
                   Date 
 
 
 

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SUMMARY   
Protocol Number: 
MPS-17IPVSS02 
Protocol Title: 
A Randomized, Single-Center, Partially Blinded, Evaluation of the Time-Dependent 
Antimicrobial Effectivess of Swabsticks Impregnated with 2% (w/v) Chlorhexidine 
Gluconate in 70% (v/v) Isopropyl Alcohol in Healthy Volunteers 
Planned Sample Size: 
This study will include a minimum of 516 evaluable subjects to achieve 280 
evaluable sites per anatomical location for the investigational product (IP), active 
control (AC), and negative control (NC) and 192 evaluable sites per anatomical 
location for the reference standard (RS). 
Study Design:  
This single site study is a randomized, controlled, partially-blinded design enrolling 
a minimum of 516 healthy volunteers, where each subject will receive two of the 
planned study products on the product application sites of the abdomen and/or groin. 
Study Methodology: 
 
ASTM Standard Test Method E1173-15 
Study Population: 
Healthy male and female volunteers, 18 years of age or older. 
Screening Day bacterial count requirements of at least 3.20 log10/cm2 on the 
abdomen and 5.50 log10/cm2, on the groin. 
Product Application Day baseline bacterial count requirements are in the range of 
3.20 to 6.00 log10/cm2, inclusive, on the abdomen or 5.50 to 7.50 log10/cm2, 
inclusive, on the groin. 
 
Objectives: 
 
To demonstrate the antimicrobial activity of the Investigational Product (IP) 
administered as a single Swabstick application by comparing counts of resident skin 
microbes, obtained after IP application to intact skin of the abdomen and groin, to 
counts obtained prior to application. 
 
In this study, the antimicrobial activity of the IP will be investigated according to 
established testing requirements described by Health Canada (HC) and the US FDA. 
 
Efficacy Objectives according to HC testing requirements 
Primary Objective: To demonstrate the immediate and persistent antimicrobial 
activity of a single Swabstick impregnated with 2% (w/v) chlorhexidine gluconate in 
70% (v/v) isopropyl alcohol at 30 seconds and 6 hours post product application.  
 
Exploratory Objectives: 1) To evaluate the log10 reductions from baseline for the 
IP and RS at each anatomical site at 10 minutes post product application. 2) To 
determine if the 30-second, 10 minutes and 6 hour log10 reductions on the abdomen 
and groin for the IP are not statistically worse than those for 60% v/v 1-propanol 
post product application.  
 
 
 

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Protocol Number: 
MPS-17IPVSS02 
Efficacy Objectives according to FDA testing requirements 
Primary Objectives: 1) To demonstrate superior antimicrobial activity of the IP, a 
single Swabstick impregnated with 2% (w/v) chlorhexidine gluconate in 70% (v/v) 
isopropyl alcohol, to a negative control (NC) of 0.9% normal saline and the non-
inferiority of the IP to an active control (AC) at the immediate time point of 10 
minutes on the abdomen and groin. 2) To demonstrate persistence of the IP at 6 
hours post product application on the abdomen and the groin. 
 
Secondary Objective: To demonstrate superior antimicrobial activity of the IP, a 
single Swabstick impregnated with 2% (w/v) chlorhexidine gluconate in 70% (v/v) 
isopropyl alcohol, to a negative control (NC) of 0.9% normal saline and the non-
inferiority of the IP to an active control (AC) at 30 seconds post product application 
on the abdomen. 
 
Exploratory Objectives: 1) To evaluate the log10 reductions from baseline for the 
IP, AC and NC at each anatomical site at 30 seconds, 10 minutes, and 6 hours post 
product application. 2) To evaluate the amount of product applied (g) to each 
anatomical site for each product. 
 
Safety Objectives: To evaluate safety using skin irritation scores and the incidence 
of adverse events reported during the study. 
Study Endpoints and 
Acceptance Criteria: 
Efficacy Endpoints: 
The primary endpoint will be log10 CFU/cm2 of skin before and after product 
application at 30 seconds, 10 minutes and 6 hours on the abdomen and groin. 
 
Acceptance Criteria according to HC analysis: 
For the IP: 
1. Immediate effectiveness is at least a 2-log10 CFU/cm2 reduction from 
baseline skin flora counts for the abdomen at 30 seconds. 
2. Immediate effectiveness is at least a 3-log10 CFU/cm2 reduction from 
baseline skin flora counts for the groin at 30 seconds. 
3. Persistence effectiveness is at least a 2- log10 CFU/cm2 reduction from 
baseline skin flora counts for the abdomen at 6 hours. 
4. Persistence effectiveness is at least a 3- log10 CFU/cm2 reduction from 
baseline skin flora counts for the groin at 6 hours. 
 
The reference standard, 60% v/v 1-Propanol, should meet the same efficacy 
standards as the investigational product. 
 
 
 
 

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Protocol Number: 
MPS-17IPVSS02 
Acceptance Criteria according to FDA analysis: 
 
For assessment of the primary objectives (i.e., immediate activity at 10 minutes post 
application on the abdomen and groin):  
1. A non-inferiority criterion with a 0.5 log10 margin will be implemented for 
the average treatment effect (ATE) of the IP compared to the AC (i.e., the 
upper two-sided 95% confidence bound of the post-product application 
bacterial load corrected for pre-product application bacterial load of the IP – 
AC should be less than 0.5 log10). 
2. A 1.2 log10 superiority criterion will be implemented for the ATE of the IP 
compared to the NC (i.e., the lower two-sided 95% confidence bound of the 
post-product application bacterial load corrected for pre-product application 
bacterial load of the NC – IP should be greater than 1.2 log10). 
 
Persistence of efficacy will be defined at 6 hours post-application as having ≥0 log10 
reduction from baseline bacterial load. No inferential analysis will be performed on 
the 6 hour time point data. 
For assessment of the secondary objective (i.e., antimicrobial activity at 30 seconds 
post application on the abdomen):  
1. A non-inferiority criterion with a 0.5 log10 margin will be implemented for 
the ATE of the IP compared to the AC (i.e., the upper two-sided 95% 
confidence bound of the post-product application bacterial load corrected 
for pre-product application bacterial load of the IP – AC should be less than 
0.5 log10). 
2. A 1.2 log10 superiority criterion will be implemented for the ATE of the IP 
compared to the NC (i.e., the lower two-sided 95% confidence bound of the 
post-product application bacterial load corrected for pre-product application 
bacterial load of the NC – IP should be greater than 1.2 log10). 
 
Assessment of the primary endpoints (i.e., antimicrobial activity at 10 minutes post 
application on both abdomen and groin) and secondary endpoints (i.e., antimicrobial 
activity at 30 seconds post application on the abdomen) will follow a gatekeeping 
procedure: the secondary endpoints (i.e., antimicrobial activity at 30 seconds post 
application on the abdomen) will be evaluated only when the assessment of the 
primary endpoints (i.e., immediate activity at 10 minutes post application on the 
abdomen and groin) passes non-inferiority and superiority criteria on both abdomen 
and groin. 
 
Safety endpoints:  
Safety will be evaluated using skin irritation scores and the incidence of AEs 
reported during the study. 
  

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Protocol Number: 
MPS-17IPVSS02 
Study Products: 
Investigational Products (IP): 
Single Swabstick impregnated with 1.75 mL of 2% (w/v) chlorhexidine gluconate 
(CHG) in 70% (v/v) isopropyl alcohol (thermally treated) 
Reference Standard (RS): 
1.75 mL of 60% (v/v) 1-propanol applied with a single Swabstick 
Active Control (AC): 
ChloraPrep® SEPP® clear applicator-2% (w/v) chlorhexidine gluconate in 70% (v/v) 
isopropyl alcohol  
Negative Control (NC): 
1.75 mL 0.9% normal saline applied with a single Swabstick 
 
Study Products, Anatomical Sites Evaluated, Application and Dry Times, and 
Coverage Areas: 
Study 
Products 
Anatomical 
Site 
Application 
Time 
Dry Time 
Area of 
Coverage 
IP 
Abdomen 
30 seconds 
30 seconds 
2.5” x 2.5” 
(6.4 cm x 
6.4 cm) 
Groin 
2 minutes 
1 minutes 
1.3” x 5” 
(3.3 cm x 
12.7 cm) 
AC 
Abdomen 
30 seconds 
30 seconds 
2.5” x 2.5” 
(6.4 cm x 
6.4 cm) 
Groin 
2 minutes 
1 minutes 
1.3” x 5” 
(3.3 cm x 
12.7 cm) 
NC 
Abdomen 
30 seconds 
30 seconds 
2.5” x 2.5” 
(6.4 cm x 
6.4 cm) 
Groin 
2 minutes 
1 minutes 
1.3” x 5” 
(3.3 cm x 
12.7 cm) 
RS 
Abdomen 
30 seconds 
30 seconds 
2.5” x 2.5” 
(6.4 cm x 
6.4 cm) 
Groin 
2 minutes 
1 minutes 
1.3” x 5” 
(3.3 cm x 
12.7 cm) 
 
 

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Statistical Methods: 
 
The full intent-to-treat (ITT) data set (all randomized subjects that received study 
product) will be used for the safety analysis. 
A modified intent-to-treat (mITT) data set will be used for efficacy analyses for both 
the FDA and HC analyses. Data included in the mITT data set is evaluated for each 
anatomical site (left and right for the groin and abdomen). For each anatomical site, if 
the Product Application Day baseline bacterial count is in the range of 3.20 to 6.00 
log10/cm2, inclusive, on the abdomen or 5.50 to 7.50 log10/cm2, inclusive, on the groin, 
then the data from that anatomical site are included in the mITT data set. 
Supportive analysis for both the FDA and HC analyses will be performed on the per-
protocol population (PP). The PP data set will include evaluable product application 
sites from the mITT data set that adhere to defined assessments and procedures in the 
protocol central to patient enrollment, safety, rights or wellbeing, as well as the 
completeness, accuracy and reliability of study data. Additional details on 
qualification for the PP data set are outlined in the Statistical Analysis Plan (SAP). 
A summary table will present log10 CFU/cm2 for each study product on each 
anatomical site at each time point.   
An analysis of variance (ANOVA) of the baseline log10 CFU/cm2 values will be 
performed separately for abdomen and groin to determine whether the randomization 
produced study product arms with similar baseline CFU/cm2 values. 
Safety Analysis: The statistical significance of differences in skin irritation between 
the study products at each post application sampling time will be evaluated by Fisher’s 
exact test on skin irritation data summarized for safety analysis as follows: any 
reaction above a zero (no reaction) on the skin irritation rating scale for any category 
(erythema, edema, rash, and dryness) will be considered a positive signal for that 
substance. If Fisher’s exact test shows statistically significant skin irritation between 
the study products, follow-up analyses will be conducted to determine how the 
reactions differ. No statistical analysis will be performed on the incidence of AEs. 
HC Efficacy Analyses 
HC Primary Analysis: Log10 CFU/cm2 changes from baseline will be calculated 
separately for each subject, each of the four sites (left and right for the abdomen and 
groin), and each post-product application sampling time by taking the baseline log10 
CFU/cm2 values and then subtracting the log10 CFU/cm2 values for the samples 
taken after baseline. The mean log10 CFU/cm2 changes from baseline will be 
calculated separately for the IP and the RS, at each anatomical site (abdomen and 
groin), and at each post-product application sampling time point (30 seconds and 6 
hours).  
The following descriptive statistics for log10 CFU/cm2 reductions will be computed 
for the IP and RS, grouped by anatomical site and each post application sampling 
time point (30 seconds and 6 hours): mean, median, standard deviation, minimum, 
maximum, and count. The 95% confidence intervals (two-sided) will be calculated 
for the observed log reductions for the IP and RS at each time point on each 
anatomical area using one-sample t-test.  
 

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The goal for the IP is that the mean log10 reduction of all four primary objectives 
meets the following criteria: 
1. The lower limit of the 95% confidence interval (two-sided) of mean log 
reduction at 30 seconds will be greater than or equal to 2 for the abdomen. 
2. The lower limit of the 95% confidence interval (two-sided) of mean log 
reduction at 30 seconds will be greater than or equal to 3 for the groin. 
3. The lower limit of the 95% confidence interval (two-sided) of mean log 
reduction at 6 hours will be greater than or equal to 2 for the abdomen. 
4. The lower limit of the 95% confidence interval (two-sided) of mean log 
reduction at 6 hours will be greater than or equal to 3 for the groin 
 
The HC testing requirements will only be considered met when and only when all four 
primary objectives pass HC analysis acceptance criteria. No multiplicity adjustment 
is required.  
The RS should meet the same efficacy standards as the IP. 
 
HC Exploratory Analysis: 1) The following descriptive statistics for log10 
CFU/cm2 reductions will be computed for the IP and RS, grouped by anatomical site 
and each post application sampling for the 10 minute time point: mean, median, 
standard deviation, minimum, maximum, and count. The 95% confidence intervals 
(two-sided) will be calculated for the observed log reductions for the IP and RS at 
the 10 minute time point on each anatomical area.  
 
2) Log10 CFU/cm2 reductions at 30 seconds, 10 minutes, and 6 hours on the 
abdomen and the groin for the IP will be compared to the RS using two-sample t-
test. 
 
FDA Efficacy Analyses 
FDA Primary Analysis: A linear regression model for each body site (abdomen and 
groin) will be used for primary analysis of efficacy at 10 minutes. In the model, the 
response is the post-product application bacterial counts at 10 minutes and predictors 
are the study products as a fixed effect and the pre-product application bacterial 
loads as a covariate. The ATE corrected for pre-product application bacterial loads 
will be estimated from the model and compared to both non-inferiority and 
superiority criteria. 
 The FDA testing requirements for the primary analysis will only be considered met 
when and only when all four primary objectives (10 minutes for both abdomen and 
groin) pass FDA analysis acceptance criteria, no multiplicity adjustment is required.  
To evaluate the persistent antimicrobial properties of a single Swabstick impregnated 
with 2% (w/v) chlorhexidine gluconate in 70% (v/v) isopropyl alcohol, log10 bacterial 
counts at 6 hours post product application for each product application site will be 
converted to a binary (yes or no) success measure with success defined as having skin 
flora counts that are less than or equal to the baseline skin flora counts. Responder 
rates at 6 hours post product application will be summarized descriptively for each 

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product on each body site. No inferential analysis will be performed on the 6 hour 
time point data.  
FDA Secondary Analysis: The secondary objectives will be evaluated only when 
the four co-primary objectives pass both non-inferiority and superiority criteria. A 
linear regression model for the abdomen will be used for a secondary analysis of 
efficacy at 30 seconds. In the model, the response is the post-product application 
bacterial counts at 30 seconds and predictors are the study products as a fixed effect 
and the pre-product application bacterial loads as a covariate. The ATE corrected for 
pre-product application bacterial loads will be estimated from the model and 
compared to both non-inferiority and superiority criteria. 
FDA Exploratory Analyses: 
The following descriptive statistics for log10 CFU/cm2 reductions will be computed 
for the IP, AC and NC at each anatomical site at 30 seconds, 10 minutes, and 6 hours 
post product application: mean, median, standard deviation, minimum, maximum, 
and count. 
Product weight expression will be calculated as product weight prior to product 
application (g) – product weight post-product application (g). The following 
descriptive statistics for expression weight will be computed for each product at each 
anatomical site: mean, median, standard deviation, minimum, maximum, and count.   
 
 
 

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Table of Contents  
SUMMARY .................................................................................................................................... 4 
LIST OF ABBREVIATIONS AND DEFINITION OF TERMS ................................................. 14 
1.0 
INTRODUCTION ............................................................................................................ 15 
2.0 
OBJECTIVES ................................................................................................................... 15 
 
Safety Objectives ............................................................................................................... 15 
 
Health Canada Analysis .................................................................................................... 15 
2.2.1 
Primary Efficacy Objectives ................................................................................ 15 
2.2.2 
Exploratory Objectives ......................................................................................... 16 
 
FDA Efficacy Analysis ..................................................................................................... 16 
2.3.1 
Primary Objectives ............................................................................................... 16 
2.3.2 
Secondary Objectives ........................................................................................... 16 
2.3.3 
Exploratory Objectives ......................................................................................... 16 
3.0 
STUDY DESIGN.............................................................................................................. 17 
 
Overall Study Design ........................................................................................................ 17 
3.1.1 
Efficacy Endpoints ............................................................................................... 17 
3.1.2 
Safety Endpoints .................................................................................................. 17 
 
Acceptance Criteria ........................................................................................................... 17 
 
Product Application Allocation and Methods to Reduce Bias .......................................... 19 
3.3.1 
Randomization ..................................................................................................... 19 
3.3.2 
Blinding ................................................................................................................ 20 
 
Stopping Rules .................................................................................................................. 21 
4.0 
STUDY POPULATION ................................................................................................... 22 
 
Inclusion Criteria ............................................................................................................... 23 
 
Exclusion Criteria .............................................................................................................. 23 
5.0 
DESCRIPTION OF STUDY PRODUCTS ...................................................................... 24 
 
Investigational Product ...................................................................................................... 24 
a. 
Reference Standard ............................................................................................................ 24 
 
Active Control ................................................................................................................... 24 
 
Negative Control ............................................................................................................... 24 
 
Reference Products and Methods ...................................................................................... 25 
5.4.1 
Neutralization Validation ..................................................................................... 25 
5.4.2 
Sampling Solution (SS) ........................................................................................ 25 
5.4.3 
Butterfield’s Phosphate Buffered Water (PBW) .................................................. 25 
5.4.4 
Tryptic Soy Agar .................................................................................................. 25 
 
Product Labeling ............................................................................................................... 25 
 
Maintenance and Storage of Study Products ..................................................................... 25 
6.0 
STUDY METHODS ......................................................................................................... 26 
 
Study Duration .................................................................................................................. 26 
6.1.1 
Visit Schedule ...................................................................................................... 26 
6.1.2 
Subject Recruitment, Consent and Product Restriction Period ............................ 27 
6.1.3 
Pre-Screening Clipping Day Visit (if required) .................................................... 28 

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6.1.4 
Screening Day Visit.............................................................................................. 28 
6.1.5 
Pre-Treatment Day Clipping Day Visit (if required) ........................................... 29 
6.1.6 
Product Application Day Visit ............................................................................. 29 
 
Efficacy Assessments ........................................................................................................ 31 
 
Post Application Sample Collection and Assessments .................................... 31 
 
Microbial Sample Collection / Scrub Cup Technique ..................................... 32 
 
Bacterial Enumeration Methods ....................................................................... 32 
 
Safety Assessments ........................................................................................................... 33 
6.3.1 
Adverse Events ..................................................................................................... 33 
6.3.2 
Skin Irritation Score ............................................................................................. 33 
Table 6: Modified Berger Bowman Skin Irritation Rating Scale ................................................... 34 
7.0 
INTERRUPTION OR DISCONTINUATION OF PARTICIPATION ............................ 35 
 
Discontinuation of study subjects ...................................................................................... 35 
 
Discontinuation of specimen analysis. .............................................................................. 35 
 
Discontinuation Visits and Follow-up Procedures ............................................................ 35 
8.0 
RISK / BENEFIT ASSESSMENT ................................................................................... 36 
 
Potential Risks ................................................................................................................... 36 
 
Potential Benefits .............................................................................................................. 36 
9.0 
SAFETY ........................................................................................................................... 36 
 
Adverse Event Definitions ................................................................................................ 36 
 
Adverse Event (AE) Management..................................................................................... 37 
9.2.1 
Follow-up of Adverse Events (AEs) .................................................................... 37 
 
Assessment of Adverse Events (AEs) ............................................................................... 38 
 
Additional procedures for Assessing & Reporting Serious Adverse Events (SAE) ......... 39 
9.4.1 
Reporting Obligations to IRB/EC and Health Authorities ................................... 40 
10.0 
INCIDENTS ..................................................................................................................... 41 
11.0 
RETURN OR DESTRUCTION OF STUDY PRODUCT ............................................... 41 
12.0 
DATA COLLECTION AND MANAGEMENT .............................................................. 42 
 
Source Documents ............................................................................................................. 42 
 
Electronic Case Report Forms (eCRF) .............................................................................. 42 
 
Electronic Source Data ...................................................................................................... 42 
 
Data Management and Storage .......................................................................................... 42 
13.0 
STATISTICAL METHODS ............................................................................................. 42 
 
Sample Size Determination ............................................................................................... 42 
 
Adjustments for Multiple Objectives ................................................................................ 43 
 
Study Populations .............................................................................................................. 44 
 
Handling of Missing Data ................................................................................................. 44 
 
Statistical Methods ............................................................................................................ 44 
13.5.2 HC Exploratory Analyses ..................................................................................... 45 
13.5.3 FDA Primary Analysis ......................................................................................... 45 
13.5.4 FDA Secondary Analysis ..................................................................................... 46 
13.5.5 FDA Exploratory Analysis ................................................................................... 46 
13.5.6 Safety Analysis ..................................................................................................... 46 

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Demographics/Other descriptive information ................................................................... 46 
14.0 
QUALITY CONTROL AND ASSURANCE .................................................................. 47 
 
Accountability of Study Products ...................................................................................... 47 
 
Monitoring ......................................................................................................................... 47 
 
Audits and Inspections ...................................................................................................... 47 
 
Protocol Deviations ........................................................................................................... 48 
15.0 
ETHICAL AND REGULATORY STANDARDS ........................................................... 48 
 
IRB/EC .............................................................................................................................. 48 
 
Informed Consent .............................................................................................................. 48 
 
Confidentiality of Data ...................................................................................................... 48 
 
Protocol Modifications ...................................................................................................... 49 
 
Study Discontinuation ....................................................................................................... 49 
 
Study Registration ............................................................................................................. 49 
 
Publication of Results ........................................................................................................ 49 
 
Record Retention ............................................................................................................... 50 
16.0 
BIBLIOGRAPHY/REFERENCES................................................................................... 50 
17.0 
PROTOCOL REVISION HISTORY ............................................................................... 51 
18.0 
APPENDICES .................................................................................................................. 60 
APPENDIX 1 DIAGRAM OF ANATOMICAL SITES .............................................................. 61 
APPENDIX 2 EXAMPLE RANDOMIZATION SCHEME ........................................................ 62 
APPENDIX 3 SUBJECT INSTRUCTIONS FOR NEUTRALIZATION STUDY ..................... 63 
APPENDIX 4 SUBJECT INSTRUCTIONS FOR MAIN STUDY ............................................. 64 
APPENDIX 5  STUDY PRODUCT APPLICATION INSTRUCTIONS .................................... 65 
APPENDIX 6 NEUTRALIZATION STUDY.............................................................................. 67 
 
 
 
 
 
 
 
 
 
 

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LIST OF ABBREVIATIONS AND DEFINITION OF TERMS 
 
AC 
Active control 
AE 
Adverse event 
ANOVA 
Analysis of variance 
ATE 
Average treatment effect 
BD 
Becton, Dickinson and Company 
CFR 
Code of Federal Regulations 
CFU 
Colony Forming Units 
CHG 
Chlorhexidine gluconate 
CI 
Confidence Interval 
CRF 
Case Report/Record Form 
DMC 
Data Monitoring Committee 
EDC 
Electronic Data Capture 
FDA 
Food and Drug Administration 
FDAAA 
FDA Amendments Act of 2007 
GCP 
Good Clinical Practice 
GMP 
Good Manufacturing Practices 
HC 
Health Canada 
IB 
Investigator’s brochure 
ICH 
International Conference on Harmonization 
IP 
Investigational product 
IRB/EC 
Institutional or Independent Review Board/Ethics Committee 
ITT 
Intent to treat 
IUD 
Intra-uterine device 
LLOQ 
Lower limit of quantification 
mITT 
Modified Intent to Treat 
NC 
Negative control 
NDA 
New Drug Application  
PBW 
Phosphate Buffered Water 
PP 
Per-Protocol 
QA 
Quality assurance 
RS 
Reference Standard 
SAE 
Serious Adverse Event 
SD 
Standard deviation 
SOP 
Standard Operating Procedure 
SS 
Sampling solution 
TSA 
Trypticase Soy Agar 
TSA + N 
Trypticase soy agar containing neutralizers 
TFM 
Tentative Final Monograph 
UPT 
Urine pregnancy test 
v/v 
Volume per volume 
WHO 
World Health Organization 
w/v 
Weight per volume 

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1.0 
INTRODUCTION 
Topical antimicrobial products are used prior to surgery in order to reduce the risk of nosocomial infection by 
reducing the number of microorganisms on the skin.  
Chlorhexidine gluconate (CHG) was first introduced in the United States in the 1970s as a hand washing agent for 
healthcare workers. It is a broad-spectrum antiseptic against Gram-positive and Gram-negative bacteria and has fair 
fungicidal effects. CHG binds strongly to skin and has residual properties documented up to 48 hours. Isopropyl 
alcohol (IPA) has a long history of use as a topical antiseptic and is included in many over-the-counter products, 
such as hand sanitizers and other skin preparations products, due to its immediate broad-spectrum antimicrobial 
effects. The combination of CHG and IPA provides an antiseptic product for intact skin that produces immediate 
and persistent antimicrobial effects against many species of microorganisms. Numerous clinical studies support the 
use of the alcoholic CHG formulations, driving its wide adoption by clinicians worldwide.  
In this study, the antimicrobial activity of the investigational product (IP), a single Swabstick impregnated with 
1.75 mL of 2% (w/v) chlorhexidine gluconate (CHG) in 70% (v/v) isopropyl alcohol, will be investigated 
according to established testing requirements described by Health Canada (HC) and the US FDA. For evaluation 
of efficacy using HC analysis criteria, to meet the immediate and persistent effectiveness standards, the IP should 
achieve a mean 2-log10 per cm2 reduction on the abdomen site and a mean 3-log10 per cm2 reduction on the groin 
site. A reference standard, 60% v/v 1-Propanol, will be applied with a single Swabstick and will also be compared 
to the same log reduction standards the IP. Immediate antimicrobial activity will be evaluated at 30 seconds and 
persistent antimicrobial activity will be evaluated at 6 hours post-product application on the abdomen and the 
groin. 
 
For evaluation of antimicrobial activity using the FDA analysis criteria, the immediate and persistent antimicrobial 
efficacy of the IP will be evaluated. For immediate activity, the IP will be compared to a negative control (NC) of 
0.9% saline and the ChloraPrepTM SEPP® Clear Applicator active control (AC). The primary objective is to 
demonstrate superiority of the IP compared to the NC and non-inferiority of the IP to the AC at the immediate time 
point of 10 minutes post product application on the abdomen and the groin. The persistent antimicrobial primary 
objective is to demonstrate that microbial levels remain at or below baseline levels 6 hours post product application. 
If the primary immediate objective passes both the non-inferiority and superiority criteria on abdomen and groin, 
then the secondary objective will be evaluated for antimicrobial efficacy. The secondary objective is to demonstrate 
superior antimicrobial activity of the IP compared to the NC and non-inferiority of the IP to the AC at 30 seconds 
post product application on the abdomen only.  
2.0 
OBJECTIVES 
 Safety Objectives 
To evaluate safety using skin irritation scores and the incidence of adverse events reported during the study for all 
study products. 
 Health Canada Analysis 
2.2.1 
Primary Efficacy Objectives 
To demonstrate the immediate and persistent antimicrobial activity of a single Swabstick impregnated with 2% 
(w/v) chlorhexidine gluconate in 70% (v/v) isopropyl alcohol at 30 seconds and 6 hours post product application. 
 
To meet the immediate effectiveness standards, the IP should achieve a mean 2-log10 per cm2 reduction on the 
abdomen site and a mean 3-log10 per cm2 reduction on the groin site at 30 seconds. The primary efficacy objective 

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for persistent effect is the IP meets the same log10 CFU/ cm2 reduction goals at 6 hours as for 30 seconds. The 
reference standard of 60% v/v 1-propanol (RS) applied with a Swabstick, should meet the same efficacy standards 
as the IP. 
2.2.2 
Exploratory Objectives 
The first exploratory objective is to evaluate the log10 CFU/cm2 reductions from baseline for the IP and RS at each 
anatomical site, abdomen and groin, at 10 minutes post-product application.  The second exploratory objective is 
to determine if the 30-second, 10 minutes and 6 hour log10 CFU/cm2 reductions on the abdomen and groin for the 
IP are not statistically worse than those for 60% v/v 1-propanol post product application. 
 FDA Efficacy Analysis 
2.3.1 
Primary Objectives 
To demonstrate the immediate and persistent antimicrobial properties of a single Swabstick impregnated with 2% 
(w/v) chlorhexidine gluconate in 70% (v/v) isopropyl alcohol to ChloraPrep® SEPP® Clear Applicator AC and a 
NC of 0.9% normal saline at 10 minutes and 6 hours post product application.  
To demonstrate immediate antimicrobial efficacy at 10 minutes post-application, there are four co-primary 
objectives for the IP. The first two objectives are to demonstrate the non-inferiority of the average treatment effect 
(ATE) of the IP compared to the AC (i.e., the upper two-sided 95% confidence bound of the post-product application 
bacterial counts corrected for pre-product application bacterial load of the IP – AC should be less than 0.5 log10) on 
both the abdomen and the groin. The second two objectives are to demonstrate the superiority of the ATE of the IP 
compared to the NC (i.e., the lower two-sided 95% confidence bound of the post-product application bacterial 
counts corrected for pre-product application bacterial load of the NC – IP should be greater than 1.2 log10) on both 
the abdomen and the groin. 
To evaluate persistent antimicrobial efficacy at 6 hours post-product application, log10 bacterial counts for each 
product application site will be converted to a binary (yes or no) success measure with success defined as having 
skin flora counts that are less than or equal to the baseline skin flora counts. Responder rates at 6 hours post product 
application will be summarized descriptively for each product on each body site. 
2.3.2 
Secondary Objectives 
To demonstrate antimicrobial efficacy at 30 seconds post-application, there are two objectives for the IP. The first 
objective is to demonstrate the non-inferiority of the average treatment effect (ATE) of the IP compared to the AC 
(i.e., the upper two-sided 95% confidence bound of the post-product application bacterial counts corrected for pre-
product application bacterial load of the IP – AC should be less than 0.5 log10) on the abdomen. The second 
objective is to demonstrate the superiority of the ATE of the IP compared to the NC (i.e., the lower two-sided 95% 
confidence bound of the post-product application bacterial counts corrected for pre-product application bacterial 
load of the NC – IP should be greater than 1.2 log10) on the abdomen. The two secondary objectives will be 
evaluated only when the four co-primary objectives pass both non-inferiority and superiority criteria. 
2.3.3 
Exploratory Objectives 
The first exploratory objective is to evaluate the log10 CFU/cm2 reductions from baseline for the IP, AC, and NC at 
each anatomical site at 30 seconds, 10 minutes and 6 hours. For the second exploratory objective, product weight 
expression from product application will be calculated as product weight prior to product application (g) – product 
weight post-product application (g).   
 

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3.0 
STUDY DESIGN 
 Overall Study Design 
This single site study is a randomized, controlled, partially blinded, design enrolling a minimum of 516 healthy 
volunteers, where each subject will receive two of the planned study products on the product application sites of 
the abdomen and/or groin. In this study, the antimicrobial activity of the investigational product (IP), a single 
swabstick impregnated with 1.75 mL of 2% (w/v) chlorhexidine gluconate (CHG) in 70% (v/v) isopropyl alcohol, 
will be investigated according to established testing requirements described by Health Canada (HC) and the US 
FDA. The study methods for this evaluation will be based on ASTM Standard Test Method E1173-15. 
3.1.1 
Efficacy Endpoints  
The evaluation of antimicrobial activity will be based on log10 CFU/cm2 of resident microbes on skin before and 
after each product application at 30 seconds, 10 minutes, and 6 hours on the abdomen and groin.  
3.1.2 
Safety Endpoints 
The principal measures of safety will be skin reactions using the modified Berger Bowman irritation assessment 
scale and the incidence of AEs reported during the study. 
 Acceptance Criteria 
To be included in the primary analysis (modified intent-to-treat (mITT) data set), a product application site must 
have a Product Application Day microbial baseline within the stated requirements. Error! Reference source not 
found. summarizes the baseline criteria for the mITT data set for each anatomical site and the expected minimum 
efficacy country specific standards. 

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Table 1: mITT data set for each anatomical site and expected minimum efficacy standards 
Anatomical 
Product 
Application 
Site 
Product 
Application 
Day 
Baseline 
Criteria 
HC Analysis 
FDA Analysis 
Acceptance 
Criteria at 30 
sec  
Acceptance 
Criteria at 6 
hours 
Acceptance 
Criteria at 30 sec 
Acceptance 
Criteria at 10 
min 
Abdomen 
3.20 to 6.00 
log10/cm2 
Immediate 
effectiveness for 
the IP is at least 
a 2-log10 
CFU/cm2 
reduction from 
baseline skin 
flora counts at 
30 seconds. 
 
Persistence 
effectiveness for 
the IP is at least 
a 2-log10 
CFU/cm2 
reduction from 
baseline skin. 
flora counts at 6 
hours. 
 
At 30 seconds the 
upper two-sided 
95% confidence 
bound of the 
average treatment 
effect (ATE) of IP 
- AC should be 
less than 0.5 log10  
At 30 seconds the 
lower two-sided 
95% confidence 
bound of the ATE 
of NC - IP should 
be greater than 1.2 
log10 
At 10 minutes the 
upper two-sided 
95% confidence 
bound of the 
average treatment 
effect (ATE) of IP 
- AC should be 
less than 0.5 log10  
At 10 minutes the 
lower two-sided 
95% confidence 
bound of the ATE 
of NC - IP should 
be greater than 
1.2 log10 
Groin 
5.50 to 7.50 
log10/cm2 
Immediate 
effectiveness for 
the IP is at least 
a 3-log10 
CFU/cm2 
reduction from 
baseline skin 
flora counts at 
30 seconds. 
 
Persistence 
effectiveness for 
the IP is at least 
a 3-log10 
CFU/cm2 
reduction from 
baseline skin. 
flora counts at 6 
hours. 
 
None  
At 10 minutes the 
upper two-sided 
95% confidence 
bound of the ATE 
of IP - AC should 
be less than 0.5 
log10  
At 10 minutes the 
lower two-sided 
95% confidence 
bound of the ATE 
of NC - IP should 
be greater than 
1.2 log10 

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 Product Application Allocation and Methods to Reduce Bias  
3.3.1 
Randomization 
The randomization scheme for the study will be provided by the Sponsor. A sufficient number of subjects will be 
recruited and newly randomized to meet the minimum number of evaluable product application sites per study 
product arm, preserving the randomization assignment. The number of evaluable product application sites per study 
product arm per anatomical area will be monitored to determine additional subject enrollment and randomization 
to meet the required evaluable sample size. Subjects who fail to meet Product Application Day baselines will not 
be replaced. Additional subjects will be randomized to account for product application day failures. 
Subjects will be randomized to study product arms using the following block design: 
Study Product Balance 
Each subject will receive two different study products, one on the right side of the body and one on the left. 
Therefore, there are six possible study product combinations: A-B, A-C, A-D, B-C, B-D and C-D.  
A minimum of 516 evaluable subjects will be required to achieve a total of a minimum of 192 evaluable product 
application sites for groin and abdominal regions for 60% (v/v) 1-propanol (RS) and 280 evaluable product 
application sites for groin and abdominal regions for the other three study product arms. Due to the imbalance of 
the sample size between RS and other products, RS cannot be blinded. Assuming the treatment code for RS is B 
and all the other three products are either A, C or D, within each small block [i.e., every 129 (516/4) evaluable 
subjects randomized], number of subjects who receive each product combination is shown below. With 4 blocks in 
total (i.e., 516 evaluable subjects), the minimum of 192 evaluable product application sites for groin and abdominal 
regions for 60% (v/v) 1-propanol (RS) and 280 evaluable product application sites for groin and abdominal regions 
for the other three study product arms can be achieved. 
 
Product Combination 
No. of Subjects in Each Block 
A-B 
16 
A-C 
27 
A-D 
27 
B-C 
16 
B-D 
16 
C-D 
27 
Total  
129 
 
Left/Right Balance 
The application will be randomized so that each study product is applied on an equal number of left and right sides 
of the body within each block as much as possible. Due to baseline bacterial requirements the mITT data set may 
be imbalanced with regard to right and left sides upon achieving the minimum number of qualifying body sites.  
 
 

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Site and Sample Time Balance 
Each groin and abdomen product application site is divided into four sampling areas and each of these sampling 
areas is sampled once – one at baseline, one at 30 seconds, one at 10 minutes, and one at 6 hours post product 
application. Therefore, for any groin or abdomen site there are 24 possible sampling orders. 
Overall the following priority order will be used for randomization schedule design: 
1. Study product combinations will always be applied with assigned numbers in each block to preserve the 6 
potential study product combinations of the four study products. 
2. Left/right balance will be preserved – each study product will be applied an approximately equal number 
of times to each side of the body. 
3. Sampling orders will be assigned in blocks of 24 as much as possible. If the final number of subjects is not 
a multiple of 24 the remaining subjects will be assigned random non-duplicative sample orders from the 24 
possible sample orders. 
4. The blocking will be adjusted based on the final subject numbers with respect to all three factors at once, 
with priority using the order listed above. 
The Investigator is responsible for ensuring that the randomization is followed. A basic outline of a randomization 
schedule for the abdominal and groin sites is provided in APPENDIX 2. The final randomization schedule will be 
prepared by the study statistician before the initial product application.   
Subjects will be identified by their initials and a subject number.  
Randomized subjects will be assigned numbers ranging from 0001 to a four digit number equal to the total number 
of subjects needed (sufficient randomization codes will be prepared to ensure sufficient codes are available for the 
indicated maximum evaluable sample size plus subjects not meeting product application day baseline requirements). 
3.3.2 
Blinding  
Study products for the following groups will be blinded with study product codes A, B, C, or D: 
Table 1 
Blinded Study Product Codes 
Study Arm 
Study Product Code 
Product  
Investigational Product (IP) 
A, C, or D 
Single Swabstick impregnated with 2% (w/v) 
chlorhexidine gluconate (CHG) in 70% (v/v) 
isopropyl alcohol 
Reference Standard (RS) 
B 
60% 1-propanol applied with a single Swabstick 
Active Control (AC) 
A, C, or D 
ChloraPrep SEPP- 2% chlorhexidine gluconate 
in 70% isopropyl alcohol  
Negative Control (NC) 
A, C, or D 
0.9% normal saline applied with a single 
Swabstick 
 
 

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Study products cannot be blinded to staff member(s) performing product applications, sample collections, and 
irritation assessments due to package labeling of the marketed product (AC) or study procedures for the negative 
control and reference control. Additionally, the RS cannot be blinded due to the imbalanced randomization. 
Staff member(s) performing bacterial enumeration will be blinded from the identification of all study product 
assignments. In addition, the study staff performing the bacterial enumeration will not be involved in the study 
material application, or the collection of samples or skin irritation assessments. The Raw Data Sheet sections of the 
case report form will be maintained separately (from the pages within the case report form which include study 
product identifications) during the conduct phase of the study. The study staff performing the bacterial enumeration 
will record counts directly onto the Raw Data Sheet pages of the case report form without accessing the subject 
study documentation folder containing the other case report form pages. The Raw Data Sheets will be compiled 
with the entire case report form after all data recording has been completed. 
3.3.2.1 
Emergency Procedure for Unblinding 
The BD Quality Assurance (QA) manager will provide study unblinding information directly to site QA department 
manager in individual sealed envelopes (one for each blinded study product code), which will remain unopened and 
secured on site. Response of medical personnel to an AE potentially associated with the study products will not 
necessitate unblinding unless treatment is impacted. If an emergency requires unblinding, the envelope 
corresponding to the study product code that is associated with the AE will be opened by the site QA manager to 
reveal the study product identification for that single study product. If possible, the Investigator or designee will 
contact the Sponsor with notification of the intent to unblind the study product codes prior to the actual unblinding. 
If it is not possible to notify the Sponsor prior to the unblinding, the Investigator or designee will contact the Sponsor 
immediately following the unblinding procedure and follow with a written notification to document the exact 
manner in which the code was unblinded and the justification for the unblinding. The Investigator or designee shall 
also provide written notification of the unblinding to the IRB. The site QA manager will communicate the study 
product identification of the code associated with the AE to only the study personnel who require the information 
to manage the emergency. 
3.3.2.2 
Measures to Control Bias 
For this study, several measures are being used to control or reduce potential bias. Those measures include, but are 
not limited to the following: 
• Subject randomization; 
• Statistical Analysis Plan lists potential protocol deviations and rules for use of associated data in analysis; 
• Products will be labeled with treatment codes (A, B, C, D); 
• Data Management Plan outlines steps to prevent Sponsor study team members from becoming aware of treatment 
codes. 
 
 Stopping Rules 
No stopping rules for the study have been developed by the Sponsor. The Investigator is responsible for 
suspending study enrollment for reasons of subject/clinician safety and well-being.  

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4.0 
STUDY POPULATION 
Healthy male and female volunteers, 18 years of age or older, with no dermatological conditions or known history 
of sensitivity to natural rubber latex, adhesive skin products (e.g., Band-Aids, medical tapes), isopropyl alcohol or 
chlorhexidine gluconate will be enrolled into this study. A sufficient number of volunteers will be enrolled such 
that a minimum number of evaluable product application sites are available for the groin (sebaceous rich) region 
and the abdominal (sebaceous poor) region for each of the study products.  A minimum of 280 evaluable sites per 
anatomical location is required for the IP, AC, and NC. A minimum number of 192 evaluable site per anatomical 
location is required for the RS. 
The minimum number of volunteers enrolled will be 516 based on the objective to assess four study product arms 
on the required number of unique skin sites for the groin and abdomen. Subjects must satisfy all Screening Day and 
Product Application Day Inclusion/Exclusion Criteria prior to Product Application Day procedures. 
Subjects must qualify on all four abdomen and inguinal sites to be admitted into the study until such time that one 
of the anatomical sites has completed the minimal required evaluable sites, then subjects will be screened and treated 
on the remaining anatomical site.  To be included in the primary analysis (modified Intent to Treat (mITT) data set), 
a product application site must have a Product Application Day microbial baseline within the stated requirements. 
Enrollment will continue until a minimum number of subjects meeting baseline criteria on each anatomical site per 
study product arm is identified. 
Subjects will be treated utilizing bilateral applications to ensure that the study products will be evaluated on the 
sites as described in Table . Each subject has four independent product application sites: left and right sides for the 
abdomen and left and right sides for the groin. 
 
Table 3 
Estimated Number of Evaluations 
Arm 
Study Product 
Number of 
Abdomen 
Evaluations  
Number of 
Groin 
Evaluations  
Investigational 
Product 
Single Swabstick impregnated with 2% (w/v) 
chlorhexidine gluconate (CHG) in 70% (v/v) 
isopropyl alcohol 
280 
280 
Reference 
Standard  
60% 1-propanol applied with a single Swabstick 
192 
192 
Negative Control 
0.9% normal saline applied with a single 
Swabstick 
280 
280 
Active Control 
ChloraPrep SEPP- 2% chlorhexidine gluconate 
in 70% isopropyl alcohol  
 
280 
280 
 
 
 

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 Inclusion Criteria 
Individuals that satisfy all of the following conditions will be considered for participation: 
1. Read, understand, and provide signed informed consent. 
2. Are healthy subjects in good general health 
3. Are 18 years of age or older 
4. If females of childbearing potential, are using an acceptable form of birth control for at least 28 days 
immediately preceding Day 1 and throughout the duration of the study. Acceptable methods are established, 
effective hormonal contraception (oral/implant/injectable/transdermal/intra-vaginal),  intra-uterine device 
[IUD], diaphragm with spermicide, condom with spermicide, abstinence, bilateral tubal ligation, or are in 
a monogamous relationship with a partner who has had a vasectomy 
5. In the case of females of childbearing potential, have a negative urine pregnancy test (UPT) on Product 
Application Day prior to any applications of the study products.. 
6. Are free of any systemic or dermatologic disorder, which, in the opinion of the Investigator, will interfere 
with the study results or increase the risk of AEs 
7. Have minimal Screening Day bacterial count requirements of 3.20 log10/cm2 on the abdomen and 5.50 
log10/cm2 on the groin. 
 Exclusion Criteria 
Subjects with any of the following characteristics will be excluded from participation in this study: 
1. Have had exposure to topical or systemic antimicrobials or any other product known to affect the normal 
microbial flora of the skin, antibiotics or steroids (other than hormones for contraception or post-
menopausal reasons) within the product restriction period and for the remainder of the study. Restrictions 
include, but are not limited to antimicrobial soaps, antiperspirants/deodorants, shampoos, lotions, perfumes, 
after shaves, and colognes 
2. Subjects who have a history of skin allergies. 
3. Have known allergies or sensitivity to vinyl, latex (rubber), alcohols, metals, inks, common 
consumer/beauty products, tape adhesives, or to common antibacterial agents found in soaps, lotions, or 
ointments, particularly chlorhexidine, or any other product components 
4. Swimming in chemically treated pools or bathing in hot tubs, spas and whirlpools within the product 
restriction period and for the remainder of the study. 
5. Use of tanning beds, hot waxes, or depilatories, including shaving (in the applicable product application 
areas) within the product restriction period and for the remainder of the study 
6. Have had exposure of the product application sites to strong detergents, acids, bases, bug repellant, fabric 
softener-treated clothing, UV treated clothing, other household chemicals in the applicable product 
application areas or other irritants during the product restriction period or during the study period 
7. Have a history of skin cancer within 6 inches of applicable product application areas, or are currently being 
treated for skin cancer or have received treatment for any type of internal cancer within the 5 years prior to 
enrollment 

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8. Subjects who have a history of asthma, diabetes, hepatitis B or C, an organ transplant, mitral valve prolapse 
with a heart murmur, congenital heart disease, lupus, Crohn’s disease, medicated multiple sclerosis, internal 
prosthesis or any immunocompromised conditions (such as AIDS or HIV positive) 
9. A currently active skin disease or inflammatory skin condition (for example contact dermatitis) anywhere 
on the body 
10. Any tattoos or scars (including stretch marks) on the product application sites or within 2 inches of the 
product application sites; skin blemishes or warts may be permissible with the specific approval of the 
Investigator or consulting physician 
11. Dermatoses, cuts, lesions, active skin rashes, scabs, breaks in the skin or other skin disorders within 6 inches 
on or around the product application sites 
12. Subjects who have showered or bathed within at least 72 hours of the Product Application Day. Sponge 
baths may be taken, however, the lower abdomen and upper thigh region must be avoided 
13. Subjects who have an irritation score of 1 or greater (any redness, swelling, rash, or dryness present at any 
product application area) for any individual skin condition prior to the Product Application Day baseline 
sample collection 
14. Are females who are pregnant, plan to become pregnant during the study, or are breastfeeding a child 
15. Are unable to adhere to or understand the protocol 
16. Have used an investigational drug or participated in an investigational study within 30 days prior to signing 
the informed consent for this study or are currently participating in a clinical study. 
17. Are employed by or are a family member of staff of BD or the study site conducting the study. 
5.0 
DESCRIPTION OF STUDY PRODUCTS 
Specific blinded product lot numbers will be included on separate Study Product release/receipt form provided by 
the Sponsor with the shipment of the materials. 
 Investigational Product  
Single Swabstick impregnated with 1.75mL of 2% (w/v) chlorhexidine gluconate (CHG) in 70% (v/v) isopropyl 
alcohol (thermally treated) 
a. Reference Standard 
1.75 mL of 60% (v/v) 1-propanol applied with a Swabstick. The 1-propanol will be European Pharmacopeia 
grade material and diluted per BS EN 12791:201610. 
 Active Control 
ChloraPrep® SEPP® clear applicator -2% (w/v) chlorhexidine gluconate in 70% (v/v) isopropyl alcohol  
 Negative Control  
1.75mL 0.9% normal saline applied with a Swabstick  

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 Reference Products and Methods 
The equipment and supplies used during this study will be detailed on Equipment and Supplies Tracking Form, and 
the form will be included in the Final Report. 
5.4.1 
Neutralization Validation 
The effectiveness of the neutralizer system must be validated prior to the study start date to demonstrate that the 
antimicrobials are effectively neutralized and there is no effect on the growth of microorganisms. A procedure that 
will include in-vivo sampling will be combined with an in-vitro evaluation using procedures in accordance with 
ASTM E1054-08(2013).12. Three organisms, Staphylococcus epidermidis, ATCC 12228 (MSSE), Staphylococcus 
epidermidis, ATCC 51625 (MRSE), and Methicillin-resistant Staphylococcus aureus, ATCC 33592 (MRSA), will 
be evaluated. See APPENDIX 6 for full study procedures. 
5.4.2 
Sampling Solution (SS) 
 
 
5.4.3 
Butterfield’s Phosphate Buffered Water (PBW) 
312 μM KH2PO4, pH 7.2 ± 0.1 
5.4.4 
Tryptic Soy Agar 
Tryptic Soy Agar with product neutralizers (TSA+) – may be purchased or made by the study site 
 Product Labeling 
The study and commercial product labels will contain, at minimum, the following information: 
 Product identification code 
 Sponsor BD 
 Protocol number MPS-17IPVSS02 
 Blinded lot Numbers 
Investigational product (or the immediate packaging) shall be labeled in accordance with regulatory requirements, 
including the following statement: " CAUTION:  New Drug – Limited by United States Law to Investigational Use 
Only” 
 Maintenance and Storage of Study Products 
Investigational product and active control product will be supplied and shipped to the site by BD and stored at 
controlled room temperature between 20-25 °C (68-77°F). Excursions permitted to 15-30°C (59-86°F). Becton 
Dickinson will supply the dry single Swabsticks for the reference standard and the negative control. The reference 
standard of 1-propanol and the negative control of 0.9% normal saline will be supplied by the site. 
The storage conditions for the study product(s) will be described on the product label(s). 
All products should be stored in accordance with instructions from BD and local procedures and retained in secure 
quarantine when not being used in the application process. A complete inventory of the study products and a log of 
use will be kept at the site. 

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Unused, sealed study products will be stored until BD specifies its disposition. In the absence of a disposition 
request from BD within 1 year of planned usage, the study products will be returned to BD. No unused study 
products will be destroyed unless confirmed by BD. 
6.0 
STUDY METHODS 
 Study Duration 
The expected duration of this study for each subject is up to 3-4 weeks. Subjects will undergo at least a 14-day 
product restriction period followed by a qualification screening baseline visit. Subjects whose screening baseline 
samples meet the minimum values described in the Inclusion Criteria (Section 3.3) will be notified and invited to 
participate in the product application phase of the study. The product application 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 remain at the study facility for scheduled study product application and assessments to include 30-
seconds, 10-minutes, and 6-hours post-prep sampling. 
6.1.1 
Visit Schedule 
  
Table 4 
Schedule of Events 
 Procedure 
14 days or more 
prior to Screening 
Day 
2 or more days prior 
to Screening Day 
and Treatment Day 
 
Screening Day 
Product 
Application Day  
Informed Consent Obtained 
X 
 
 
 
Product-Restriction Period 
X 
X 
X 
X 
Inclusion/Exclusion Criteria 
including Medical History 
Reviewed 
X 
X 
X 
X 
Pregnancy Test 
 
 
 
X 
Skin Irritation Assessment ( 
Product restriction after 
consent) 
X 
 
 
 
Skin Irritation Assessment 
(pre-Clipping ) 
 
X 
 
 
Clipping Hair From Product 
Application sites 
 
X 
 
 
Skin Irritation Assessment 
(pre-screening sample) 
 
 
X 
 
Screening 
Day 
Baseline 
Sample 
 
 
X 
 

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Skin Irritation Assessment 
(Pre-Product Application) 
 
 
 
X 
Randomization 
 
 
 
X 
Product Application -Day 
Baseline Sample 
 
 
 
X 
Product Application 
 
 
 
X 
Skin Irritation Assessment 
(30 sec, 10 min and 6 hour  
post application)  
 
 
 
X 
 Post-Product 
Application 
Samples (30 sec, 10 min and 
6 hour)   
 
 
 
X 
Subject Self-Assessment of 6 
hour sample site  
 
 
 
X 
Technician’s Assessment of 
6 hour sample site  
 
 
 
X 
Adverse Events 
 
X 
X 
X 
Concomitant Medications 
X 
X 
X 
X 
Study product removal with 
soap and water after the 6 hr 
sample collection 
 
 
 
X 
Note:  All sampling times will be calculated from the completion of the dry time of each product following 
application. 
6.1.2 
Subject Recruitment, Consent and Product Restriction Period 
Potential subjects will be informed of volunteer opportunities available at the investigative site by means of general, 
nonspecific newspaper and radio advertisements instructing potential subjects to either read IRB-approved study 
descriptions online or in person. Additionally, subjects may be recruited from existing subject database, referrals, 
through response to advertising and from community outreach events. All study-specific advertising materials will 
be approved by the IRB prior to their use for recruiting subjects. 
 
Initial screening of subjects will be conducted at least 14 days prior to the Screening Day visit. The 
Inclusion/Exclusion Criteria will be reviewed with each subject to ensure eligibility for the study. At consent, the 
site will perform a skin irritation assessment and verify that the skin of the abdomen and groin are free from 
clinically evident dermatoses, injuries, or any other disorders that may compromise the subject or the study. Subjects 
will receive any necessary written and verbal information, and the informed consent of each subject will be obtained.   
 
A list of restricted products will be provided to each subject. Prior to the scheduled Screening Day visit, subjects 
will undergo a minimum 14-day product restriction period. The subjects will be instructed to avoid contact with 
any topical or systemic antimicrobial products for the duration of their involvement in the study as written in the 

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Subject Instructions. If it becomes necessary to take systemic antibiotics or to apply topical antimicrobial products 
within this pre-product application period, the subject will be discontinued from the study. 
Restrictions include, but are not limited to: 
 
Use of antimicrobial soaps, shampoos, lotions, perfumes, after shaves or powders, colognes, 
antiperspirants, deodorants 
 
Contact with materials such as acids, bases, solvents, bug repellant, fabric softener-treated clothing, UV 
treated clothing or other household chemicals 
 
Swimming in chemically treated pools and bathing in hot tubs, spas and/or whirlpools 
 
Use of tanning beds, hot waxes or depilatories (including shaving) 
Prior to the start of the product restriction period, subjects will be provided a kit with non-antimicrobial personal 
care products for exclusive use during the study. Subjects will also be provided with written instructions regarding 
the use of these products. 
A visual skin assessment (Table 6) of the product application areas will be performed. If subjects require hair 
removal to facilitate sample collection, the subject will be asked to return to the study facility for a Pre-Screening 
Clipping Day Visit. Subjects will be required to refrain from bathing or showering for 72 hours prior to the 
Screening Day and Product Application Day visits. 
6.1.3 
Pre-Screening Clipping Day Visit (if required) 
Approximately 48-96 hours prior to Screening Day, the Investigator or a designee will complete the Pre-
Screening Day Inclusion/Exclusion Criteria Page in each subject’s case report form (CRF). If these criteria are 
satisfied, a visual skin assessment will be performed to evaluate the condition of each test area and hair will be 
clipped. If a subject’s Screening Day Visit exceeds 96 hours from clipping, then the subject will be scheduled for 
re-clipping to ensure hair is removed approximately 48-96 hours prior to Screening Day. 
Subjects will be reminded to refrain from bathing or showering for at least 72 hours prior to Screening Day. 
6.1.4 
Screening Day Visit 
After the product restriction period and at least 3-days before Product Application Day, the Investigator or a 
designated sub-investigator will complete the Screening Day Inclusion/Exclusion Criteria page in each subject’s 
CRF.  
 
Prior to performing the Screening Day baseline sample collection, a skin irritation assessment will be performed 
by the Investigator or designated sub-investigators trained by the Investigator. If an irritation score of 1 or greater 
is assigned for any individual skin condition at the Screening Day baseline, the subject will be excluded from the 
study. 
 
The product application site within the abdominal region (abdominal product application area) is defined as the 
area to the right and left sides of the abdomen, adjacent to the umbilicus that appear to be similar in condition and 
above the groin (APPENDIX 1). The product application site within the groin region (groin product application 
area) is defined as the inner aspect of the upper thigh within and parallel to the inguinal crease below the groin 
(APPENDIX 1).  Using a 2.5” x 2.5” (6.4 cm x 6.4 cm) sterile template for the abdomen, or a 1.3” x 5” (3.3 cm x 
12.7 cm) sterile template for the groin, the corners of each product application area will be marked directly on the 
skin using a non-toxic skin marker. Four sampling sites will be numbered within each abdominal product 
application area according to APPENDIX 1 for each anatomical location. The positioning and numbering of the 

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sampling sites are standard for all subjects on each anatomical location.  Sampling sites on the contra-lateral side 
of each anatomical location will be numbered in a mirror-image orientation.   
 
A baseline screening sample will be collected from each product application area using the Williamson-Kligman 
scrub cup technique. The screening baselines samples will be taken from site #1 within each product application 
site on the abdomen (left and right sides) and site #3 within each product application site on the groin (left and 
right sides). Samples from both the left and right sides of a body region must meet the minimum value indicated 
in the Inclusion Criteria for the subject to be enrolled into the product application phase of the study for that 
region. Subjects must qualify on all four abdomen and inguinal sites to be admitted into the treatment phase of the 
study until such time that one of the anatomical sites has completed the minimal required evaluable sites, then 
subjects will be screened and treated only on the remaining anatomical site. 
Subjects who qualify for the study will be notified and will continue to follow the subject instructions until their 
participation has been completed. Subjects will again be required to refrain from bathing or showering 72 hours 
prior to Product Application Day and hair will be clipped, if required. 
6.1.5 
Pre-Treatment Day Clipping Day Visit (if required) 
Approximately 48-96 hours prior to Treatment Day, the Investigator or a designee will complete the Pre-
Treatment Day Inclusion/Exclusion Criteria page in each subject’s case report form (CRF).  If these criteria are 
satisfied, a visual skin irritation assessment will be performed to evaluate the condition of each test area and hair 
will be clipped. If a subject’s Treatment Day Visit exceeds 96 hours from clipping, then the subject will be 
scheduled for re-clipping to ensure hair is removed approximately 48-96 hours prior to Treatment Day. 
Subjects will be reminded to refrain from bathing or showering for at least 72 hours prior to Treatment Day. 
6.1.6 
Product Application Day Visit 
The Investigator or a designated sub-investigator will complete the Product Application Day Inclusion/Exclusion 
Criteria CRF.  If these criteria are satisfied, a visual skin assessment will be performed to evaluate the condition of 
each product application area. If all criteria are met, the subject will be assigned a randomization number. 
Subjects will be provided with gowns, disposable sterile gloves and underwear for use on Product Application Day. 
Each subject who chooses to participate in this study will be required to change prior to baseline sampling into the 
gown and underwear provided as well as remain at the study facility for the scheduled assessments to include 30 
seconds, 10 minutes and 6 hours post-product application sampling. Additionally, subjects who choose to participate 
will be required to wear disposable sterile gloves prior to the baseline sampling scheduled assessment through the 
30-second and 10- minute post-product application sampling.  
The randomization schedule will designate the product application to each side of the abdomen and groin. 
6.1.6.1 
Preparation of abdominal product application area 
A skin irritation assessment will be performed by the Investigator or designee trained by the Investigator, using the 
Skin Irritation Rating Scale (Table 6). If an irritation score of 1 or greater is assigned for any individual skin 
condition at the Product Application Day baseline, the subject will be excluded from the product application phase 
of the study for the abdomen. 
The product application site within the abdominal region (abdominal product application area) is defined as the area 
to the right and left sides of the abdomen, adjacent to the umbilicus that appear to be similar in condition and above 
the groin (APPENDIX 1). Using a 2.5” x 2.5” (6.4 cm x 6.4 cm) sterile template, the corners of each abdominal 
product application area will be marked directly on the skin using a non-toxic skin marker. Four sampling sites will 

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be numbered within each abdominal product application area, on each side of the abdominal region. The positioning 
and numbering of the abdominal sampling sites are standard for all subjects. Sampling sites on the contra-lateral 
side of the abdomen will be numbered in a mirror-image orientation. The four sampling sites within each abdominal 
product application area represent one baseline (pre-application) site and three post-application sample sites 
(30seconds, 10-minutes, and 6-hours). 
After abdominal product application areas are marked and sample sites numbered, baseline samples will be 
collected from the appropriate site per the randomization schedule in each product application area using the scrub 
cup technique (see Section 6.3.1.1 Microbial Sample Collection/ Scrub Cup Technique). 
6.1.6.2 
Preparation of Groin product application Area 
A skin irritation assessment will be performed by the Investigator or designated sub-investigators trained by the 
Investigator, using the Skin Irritation Rating Scale (Table 6). If an irritation score of 1 or greater is assigned for any 
individual skin condition at the Product Application Day baseline, the subject will be excluded from the product 
application phase of the study for the groin. 
The product application site within the groin region (groin product application area) is defined as the inner aspect 
of the upper thigh within and parallel to the inguinal crease below the groin (APPENDIX 1).  Using a 1.3” x 5” (3.3 
cm x 12.7 cm) sterile template, the corners of each groin product application area will be marked directly on the 
skin using a non-toxic skin marker.  Four sampling sites will be numbered within each groin product application 
area, on each side of the groin region.  The positioning and numbering of the groin sampling sites are standard for 
all subjects.  Sampling sites on the contra-lateral side of the groin will be numbered in a mirror-image orientation.  
The four sampling sites within each groin product application area represent one baseline (pre-application) site and 
three post-application sample sites (30-seconds, 10-minutes, and 6-hours). 
After groin product application areas are marked and sample sites numbered, baseline samples will be collected 
from the appropriate site per the randomization schedule in each product application area using the scrub cup 
technique (see Section 6.3.1.1 Microbial Sample Collection/ Scrub Cup Technique). 
6.1.6.3 
Study Product Materials Application 
After baseline sample collection is completed, the randomly assigned contra-lateral product application areas will 
be treated with the assigned study product materials. 
The study products will be applied and the sampling configurations will be performed per the randomization 
schedule and the Study Product Application Instructions (Appendix 5).  The duration of application time for each 
location will be recorded. 
The study product material weight will be measured before and after application to the product application site and 
recorded as described in the Study Product Application Instructions (Appendix 5). 
Table 5 contains a summary of the study products, anatomical sites evaluated, application time, dry time and 
coverage area.  
 
 
 

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Table 5: Anatomical body sites, application times, dry times and 
coverage area for each study product. 
Study 
Product 
Body Site 
Application 
Time 
Dry Time 
Area of 
Coverage 
IP 
Abdomen 
30 seconds 
30 seconds 
2.5” x 2.5” 
(6.4 cm x 
6.4 cm) 
Groin 
2 minutes 
1 minute 
1.3” x 5” 
(3.3 cm x 
12.7 cm) 
AC 
Abdomen 
30 seconds 
30 seconds 
2.5” x 2.5” 
(6.4 cm x 
6.4 cm) 
Groin 
2 minutes 
1 minute 
1.3” x 5” 
(3.3 cm x 
12.7 cm) 
NC 
Abdomen 
30 seconds 
30 seconds 
2.5” x 2.5” 
(6.4 cm x 
6.4 cm) 
Groin 
2 minutes 
1 minute 
1.3” x 5” 
(3.3 cm x 
12.7 cm) 
RS 
Abdomen 
30 seconds 
30 seconds 
2.5” x 2.5” 
(6.4 cm x 
6.4 cm) 
Groin 
2 minutes 
1 minute 
1.3” x 5” 
(3.3 cm x 
12.7 cm) 
 Efficacy Assessments 
 Post Application Sample Collection and Assessments 
The microbial samples will be collected at 30 seconds (± 5 sec.), 10 minutes (± 30 sec.) and 6 hours (± 30 min.) 
post product application for both the abdomen and the groin regions. Post application timing begins upon 
completion of the study product application, including drying time. Microbial samples will be collected using the 
scrub cup technique (see Section 6.3.1.1 Microbial Sample Collection/ Scrub Cup Technique). 
After the 10-minute (± 30 sec.) samples have been collected, a sterile non-occlusive dressing will be secured over 
the remaining sample sites to protect the sites from contamination between sampling times. Subjects will be 
instructed to ensure the non-occlusive dressing remains intact and dry until the 6 hours sampling occurs. 
Prior to collection of the 6-hour sample, the technician will perform an assessment of the 6-hour sample site to 
determine if the gauze appears dry, clean, and intact. Subjects will also be asked to provide a verbal assessment of 
the sample site regarding any adjustments to the gauze and if the gauze remained intact and dry from time of 
placement until the 6 hour evaluation. 

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A skin irritation assessment will be performed by the Investigator or designated sub-investigators trained by the 
Investigator prior to collection of each post product application microbial sample collection (30-seconds, 10- 
minutes and 6-hours) and a corresponding rating score for each individual skin condition will be recorded in the 
subject’s CRF. 
If an irritation score of 3 is assigned for any individual skin condition at any post product application observation, 
the subject will be discontinued from the study and an AE will be recorded.  
Following final sample collection at the 6 hour time point or early study discontinuation, the remaining study 
product will be removed from the subjects’ skin using soap and water.  
 Microbial Sample Collection / Scrub Cup Technique 
Quantitative cultures (baselines and post product application) will be obtained by a modification of the cylinder 
sampling technique of Williamson-Kligman scrub cup technique. To collect the samples, a sterile scrub cup (2.20 
cm I.D., skin surface area of 3.80 cm2) will be placed on the site and held firmly to the skin. Sampling solution (SS) 
(3.0 mL) will be pipetted into the cup and the skin will be scrubbed with moderate pressure for one minute using a 
sterile rubber policeman. Using a sterile transfer pipette, the SS will be removed and placed in a sterile test tube. 
An additional 3.0 mL of fresh sampling solution will be pipetted into the cup and the scrub procedure will be 
repeated. This solution will be pooled with the first solution collected. 
 Bacterial Enumeration Methods 
Following sample collection, 10-fold serial dilutions (1 mL sample + 9 mL PBW) will be prepared using PBW.  
One-mL aliquots of appropriate dilutions will be pour-plated in triplicate using trypticase soy agar containing 
neutralizers (TSA+N). Samples must be plated within 30 minutes of collection.  
Serial dilutions of collected baseline screening samples as follows: 
- 
for groin sites: 1 serial dilution (10-3) 
- 
for abdomen sites: 1 serial dilution (10-1) 
 
Serial dilutions of collected treatment day (D0) samples as follows: 
for groin sites 
- 
Baseline: 3 serial dilutions (10-3, 10-4 and 10-5) 
- 
30 seconds: 6 serial dilutions (100, 10-1, 10-2, 10-3, 10-4 and 10-5) 
- 
10 minutes: 6 serial dilutions (100, 10-1, 10-2, 10-3, 10-4 and 10-5)  
- 
6 hours: 6 serial dilutions (100, 10-1, 10-2, 10-3, 10-4 and 10-5) 
 
for abdomen sites 
- 
Baseline: 3 serial dilutions (10-1, 10-2 and 10-3) 
- 
30 seconds: 4 serial dilutions (100, 10-1, 10-2 and 10-3) 
- 
10 minutes: 4 serial dilutions (100, 10-1, 10-2 and 10-3)  
- 
6 hours: 4 serial dilutions (100, 10-1, 10-2 and 10-3) 
 
After 72  4 hours of aerobic incubation at 30  2ºC, colonies will be counted and viable cells in the original sample 
will be calculated according to Standard Operating Procedures (SOPs). After incubation, plates may be refrigerated 
up to 48 hours prior to counting.   

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Raw colony counts from each dilution will be recorded on the appropriate CRFs for each subject.  The average 
number of microorganisms recovered will be calculated using the formula to convert the bacterial counts into 
log10 CFU/cm2 of skin: 
 
R = log10 [
𝐹(∑
𝑐𝑖
3
𝑖=1
𝑛
) 𝐷
𝐴
] 
Where: R = the average CFU count in log10 scale per cm2 of skin. 
 
F = total mL of sampling solution (SS) added to the sampling cylinder (6 mL);  
∑
ci
3
i=1
n
= average of the triplicate colony counts used for each sample collected 
 
D = Dilution factor of the plates counted. One of 100, 101, 102, 103, 104, or 105. 
 
A = Inside area of the sampling cylinder (3.80cm2) 
The average CFU/mL, CFU/cm2, and log10 CFU/cm2 will be calculated for samples from each product application 
site in the same manner. 
In order to avoid potential calculation problems due to taking the logarithm of zero, values of less than 1 CFU/cm2 
will be treated as 1 CFU/cm2, such that the log10 transformation is not less than zero. 
 Safety Assessments 
The principal measures of safety will be skin reactions using the modified Berger Bowman irritation assessment 
scale and the incidence of AEs reported during the study  
6.3.1 
Adverse Events 
The incidence of adverse events reported during this study will be collected for assessment of safety.  Details on 
the AE management, reporting and assessment can be found in Section 9.  
6.3.2 
Skin Irritation Score 
Subjects that receive study products will be monitored for skin irritation using the modified Berger Bowman 
irritation assessment scale. Skin irritation assessment will be performed as outlines in Section 6.2 Study Visits.  
If a reaction occurs on the skin test site, it may be needed to take photographs of the skin test site only. These 
photographs will be shared with the Principal Investigator / Sub-Investigator, the sponsor and the study staff only 
and will be used for the Principal Investigator / Sub-Investigator’s review and assessment of the reactions.  
 
 
 

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Table 6: Modified Berger Bowman Skin Irritation Rating Scale 
 
a = Represents significant irritation in any category and may require subject’s removal from the study. 
b = A rating of 3 on the skin irritation scale in any category will be recorded as AE and will require subject’s removal 
from the study. 
 
Skin Irritation Rating Scale 
Reactive area(s) within the product application site only 
Condition 
Rating Description 
Erythema 
0 
No reaction 
1 
Mild and/or transient redness   
2a 
Moderate redness  
3b 
Severe redness  
Edema 
0 
No reaction 
1 
Mild and/or transient swelling   
2a 
Moderate swelling   
3b 
Severe swelling   
Rash 
0 
No reaction 
1 
Mild and/or transient rash   
2a 
Moderate rash   
3b 
Severe rash   
Dryness 
0 
No reaction 
1 
Mild and/or transient dryness  
2a 
Moderate dryness   
3b 
Severe dryness   

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7.0 
INTERRUPTION OR DISCONTINUATION OF PARTICIPATION 
 Discontinuation of study subjects 
Subjects may request withdrawal from the study at any time or may be withdrawn at the discretion of the 
Investigator for any of the following reasons: 
 
Adverse Event/Concurrent Illness 
 
Noncompliance with study requirements or restrictions 
 
Failure to meet ongoing inclusion criteria, or development of an excluding condition  
 
Protocol deviation 
 
Withdrawal of consent  
 
Subject is lost to follow up  
 
Administrative issues 
 
Any other reason which, in the opinion of the Investigator, makes the subject’s participation in the study 
not in his or her best interest. 
If a subject withdraws from the study, all efforts will be made to complete a final evaluation, if possible.  
 Discontinuation of specimen analysis. 
Discontinued subjects will not be replaced. If needed, additional subjects will be enrolled with a sequential, unique 
randomization code according to the randomization schedule.  
No data will be collected from subjects after the point of discontinuation except as needed to follow ongoing AEs.  
All study data collected from the subject up to the point of discontinuation will be recorded on the CRF, entered 
into the study database, and included in subsequent analyses, as appropriate.   
 Discontinuation Visits and Follow-up Procedures  
For subjects discontinued due to AEs, the clinical course of the event will be followed according to the procedures 
outlined in section 9.2.1 Follow-up of Adverse Events. 
 
 

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8.0 
RISK / BENEFIT ASSESSMENT 
 Potential Risks 
Subjects participating in this study could experience side effects to the skin (from either the Investigational or 
Comparator products and/or study procedures) such as: 
 
skin reactions, primarily confined to the area of application 
 
local minimal or moderate erythema 
 
minimal edema 
 
application site pruritus 
 
rash 
 
papules 
 
vesicles 
 
burning sensation 
 
allergic reaction including in rare cases anaphylaxis 
Subjects may also experience folliculitis from clipping. 
There may be risks from participating in this study that are unknown. 
 Potential Benefits 
There are no direct benefits to the subject for participation in this study.  The findings may reveal information that 
will allow for a better understanding of the antimicrobial effectiveness of a single Swabstick impregnated with 
1.75mL of 2% (w/v) chlorhexidine gluconate (CHG) in 70% (v/v) isopropyl alcohol.  
9.0 
SAFETY 
 Adverse Event Definitions 
Adverse Event (AE):   
Any untoward medical occurrence in a patient or clinical investigation subject administered an investigational product 
(drug or device), which does not necessarily have to have a causal relationship with the treatment.  
An adverse Event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, 
for example), symptom, or disease temporally associated with the use of an investigational product, whether or not 
considered related to the investigational product. 
Note 1: This definition includes events related to the investigational product or the comparator. 
Note 2: This definition includes events related to the procedures involved 
 
 

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Serious Adverse Event (SAE):   
A serious adverse event is an event that in the view of either the Investigator or Sponsor, results in any of the following 
outcomes: 
 
Death 
 
life-threatening illness or injury 
 
permanent impairment of a body structure or body function 
 
in-patient hospitalization or prolongation of hospitalization 
 
injury, significant disability Fetal distress, fetal death, or a congenital abnormality or birth defect 
 
Other important medical event, that requires medical or surgical intervention to prevent any of the above 
 
Note 1: “Planned hospitalization for pre-existing condition, or a procedure required by the protocol, without serious 
deterioration in health, is not considered a serious adverse event”.  
Note 2: “Medical and scientific judgement should be exercised in deciding whether expedited reporting is appropriate 
in other situations, such as important medical events that may not be immediately life-threatening or result in death or 
hospitalization but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed in 
the definition above. These should also usually be considered serious.  Examples of such events are intensive treatment 
in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in 
hospitalization; or development of drug dependency or drug abuse”.  
 Adverse Event (AE) Management 
Collection of adverse events will begin after the subject has signed the Informed Consent form through the end of 
study conduct. 
At each study contact, the subject will be questioned in an open-ended manner regarding any new or worsening 
undesirable signs or symptoms they may have experienced since the previous contact.  Signs and symptoms must 
be comprehensively documented on the appropriate source documentation. All related signs and symptoms should 
be grouped under one diagnosis if possible. 
Each sign, symptom, disease or illness reported must be evaluated by the Investigator or designee to determine if it 
meets the definition of an AE.  
Any irritation of the application sites that results in the withdrawal of the subject from the study or, in the opinion 
of the Investigator or designate, warrants medical attention or medication will be considered AEs that will be 
subjected to the same criteria as all other AEs. 
If an AE or SAE reaction occurs on the skin test site, it may be needed to take photographs of the skin test site only. 
These photographs will be shared with the Principal Investigator / Sub-Investigator, the sponsor and the study staff 
only and will be used for the Principal Investigator / Sub-Investigator’s review and assessment of the reactions.  
9.2.1 
Follow-up of Adverse Events (AEs) 
Adverse events that are present after the  completion of the subject’s scheduled study visit will be followed up to 
14 days by means of the investigational site contacting the subject via telephone or by any other means considered 
appropriate. If the subject’s adverse event is still ongoing past the 14 days, the Investigator will communicate with 
the sponsor Medical Monitor (via telephone and/or email) as to the need for further follow-up. In the case of 
discrepancies, the Investigator’s judgement will prevail. All communications with the subject and medical monitor 
will be documented appropriately.  

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Adverse Events whose onset occurs up to 14 days after the end of the subject’s study participation, will be recorded 
and will require the Investigator to communicate with the sponsor Medical Monitor as to the need for further follow-
up as described above. All contacts will be documented appropriately.  
The clinical course of any serious adverse event will be followed according to accepted standards of medical 
practice until the event resolves, stabilizes, or in the opinion of the Investigator, is no longer considered clinically 
significant as it relates to the study product and/or study procedures. 
 Assessment of Adverse Events (AEs) 
All AEs (Serious and Non-Serious) are assessed according to severity or intensity of the event experienced by the 
subject as either mild, moderate, or severe using the definitions below:  
Note: To ensure no confusion or misunderstanding of the difference between the terms "serious" and "severe," 
which are not synonymous, the following note of clarification per ICH (E2A) Definitions and Terminology 
associated with clinical safety experience is provided : 
The term "severe" is often used to describe the intensity (severity) of a specific event (as in mild, moderate, or 
severe myocardial infarction); the event itself, however, may be of relatively minor medical significance (such as 
severe headache). This is not the same as "serious," which is based on patient/event outcome or action criteria 
usually associated with events that pose a threat to a patient's life or functioning. Seriousness (not severity) serves 
as a guide for defining regulatory reporting obligations. 
 All AEs, regardless of classification, must be comprehensively documented in the CRF and on the SAE form, if 
applicable, and reported to BD.  This includes AEs related to marketed study products.  
The following information about the event is to be collected on the AE CRF:  
 
Severity,  classified as: 
 
Mild: 
Signs or symptoms that do not interfere with the subject’s daily activity, are usually 
considered self-limiting, can be treated with non-prescription type medications and do not 
require medical intervention. 
 
Moderate: 
Event(s) may interfere or cause low level inconvenience with the subject’s daily activity. 
Requires medical intervention and/or treatment, however, unlikely to require hospitalization 
or be consider potentially life-threatening in nature. 
 
Severe: 
Event(s) may cause significant discomfort to the subject and/or interferes with the subject’s 
daily activity. Requires medical intervention and/or treatment to preclude a permanent 
impairment, can be life threatening and require hospitalization. 
 
 
 
 
 
 
 
 
 

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 
Relationship or Causality,  assessed as: 
 
Not Related: 
The AE is independent of study intervention, and/or evidence exists that the event 
is related to another etiology. There must be an alternative, etiology documented 
by the clinician. 
 
Unlikely Related: 
A clinical event, whose temporal relationship to study intervention makes a 
causal relationship improbable (e.g., the event did not occur within a reasonable 
time of the study product use) and in which underlying disease provides plausible 
explanations (e.g., the participant’s clinical condition, other concomitant 
treatments). 
 
 
Likely Related: 
There is evidence to suggest a causal relationship, and the influence of other 
factors is less likely. The clinical event occurs within a reasonable time after use 
of the study product, and is less likely to be attributed to concurrent disease. 
 
 
Related: 
There is clear evidence to suggest a causal relationship, and other possible 
contributing factors can be ruled out. The clinical event occurs in a plausible 
time relationship to use of the study product and cannot be explained by 
concurrent disease. 
 
 
In addition, the following should be recorded for each AE: 
 
Action(s) taken to remedy the AE, including change in study treatment or participation, or 
medical/surgical treatments 
 
Duration of the AE from onset through resolution, as applicable 
 
Cause (including suspected product/procedure and/or other cause) 
 
Outcome of the event, including resolution and sequelae, as applicable 
 Additional procedures for Assessing & Reporting Serious Adverse Events (SAE) 
SAE criteria are specified in Section 9.1.  All SAEs must also be assessed by the Investigator and Sponsor 
Medical Monitor to determine whether an SAE is expected or unexpected. An adverse event will be 
considered unexpected or unanticipated if the nature, severity or frequency of the event is not consistent 
with the risk information previously described in the protocol, Informed Consent, or Investigator’s 
Brochure.  
Any adverse event meeting the criteria for ‘Serious’, regardless of the Investigator’s opinion of 
expectedness or relationship to the study product, must be reported to the Sponsor within 24 hours. The 
Investigator or designee must report the event by telephone or email to the Study Monitor. In addition to 
reporting the SAE to the Study Monitor, the Investigator must also submit a completed SAE form to the 
safety email address listed below within 24 hours of receipt of the information. 
 
 

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Sponsor Notification of Serious Adverse Event: 
 
Safety Email: 
 
 
Medical questions about study safety issues and serious adverse events can be directed to the Sponsor 
Medical Monitor. 
 
 
VP, Medical Affairs, Interventional 
Segment 
 
 
 
 
9.4.1 
Reporting Obligations to IRB/EC and Health Authorities 
The Investigator must report any AEs which are serious, unanticipated/unexpected and probably or possibly related 
to the study product or procedures to the reviewing IRB/EC.  This report must be submitted as soon as possible, but 
in no event later than 10 working days after the Investigator first learns of the event.   
The Investigator may also have additional responsibilities for AE reporting to their governing Health Authority 
which they are responsible for identifying and fulfilling. 
The Sponsor will provide results of any evaluation of an unanticipated/unexpected adverse product effect to 
appropriate Health Authorities, to all Investigators, and to all reviewing IRB/ECs within 10 working days after the 
Sponsor is notified of the event.  If the Investigator wishes to assume responsibility for filing reports of evaluation 
results to their own IRB/EC in lieu of the Sponsor, they must notify the Sponsor in writing of this preference and 
must retain evidence of their compliance with this requirement. 
BD will comply with all other Sponsor safety reporting requirements and timelines for other entities (e.g., Data 
Safety Monitoring Boards) and local health authorities in other countries where this study or other studies with the 
same product are being conducted, in compliance with study procedures and applicable local regulatory 
requirements and BD Standard Operating Procedures.  
9.4.2 
Pregnancies 
Investigators must instruct subjects to inform them immediately if they become pregnant during the trial.  
In case of a pregnancy during the participation in the trial, the subject will be immediately considered for premature 
discontinuation. 
The pregnancy will be registered on the CRF/eCRF protocol deviation form. In addition, the Pregnancy Form 
(which is independent of the CRF/eCRF) will be completed and entered into the EDC with all the available 
information within the same time frame and following the same routing as for a SAE, described previously. The 
Investigator will make every effort to obtain all information related to the pregnancy and its final outcome, which 
may involve follow-up after the trial has ended. Pregnancies will be followed up for maximally 4 weeks after 
delivery or termination of the pregnancy.  

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All pregnancies discovered by the Investigator after the termination of the trial but which were initiated during the 
participation in the trial will be reported to BD (see details above) as occurring during the trial. 
10.0 
INCIDENTS 
A Study Incident is defined as any problem or issue involving the investigational product(s), reference methods, 
associated procedures or equipment, or represents a product-related injury (or potential for injury) to study subjects 
or personnel as a result of execution of this protocol.  Study Incidents may adversely (or potentially adversely) 
affect human safety, the integrity of the evaluation data, or the operation of devices or systems, and warrant prompt 
attention.  
Incidents involving injury to study subjects will also be reported as AEs (refer to Section 9.0).   Examples of Study 
Incidents that are not AEs might be mislabeling or adulteration of the investigational product, equipment 
malfunctions, errors in the investigational product instructions, damage to investigational product caused by 
shipping or handling or improper storage, or injury to study personnel due to execution of the protocol.  If 
appropriate, an Incident may also be documented and reported as a protocol deviation.  
Study-specific procedures for reporting Incidents, as well as AEs and protocol deviations, will be provided to the 
study site prior to study execution.  The Monitor should be contacted immediately when site becomes aware of or 
suspects any defective or malfunctioning product. This includes: 
• 
Products that are involved in Study Incidents, 
• 
Products that are found to be expired, damaged or defective, 
• 
Products that are possibly the cause of an adverse effect, regardless of whether the product was believed to 
be damaged, defective or malfunctioning.  
Such products (whether investigational or marketed) should be segregated and returned with appropriate 
documentation to the BD address below, unless instructed otherwise by BD. The Study Monitor should be contacted 
with any questions regarding return of study products. BD will supply mailing kits specifically intended for product 
contaminated with potentially bio-hazardous material. 
11.0 
RETURN OR DESTRUCTION OF STUDY PRODUCT 
All disposable, used products are to be discarded into appropriate waste containers at the investigational site. Failed, 
damaged or products involved in an Incident or AE/SAE should be returned to BD for further investigation or 
disposal by BD.  
Unless instructed otherwise by BD, the Investigator will return all remaining unused or unopened IP, reference, and 
ancillary study products to BD.  At the conclusion of the study, and as appropriate during the course of the study, 
any products, supplies or BD equipment that are required to be returned will be shipped to BD at the address below, 
unless instructed otherwise: 
BD 
ATTN: R&D Supply Shipments Coordinator 
75 N. Fairway Drive 
Vernon Hills IL 60061 
 

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12.0 
DATA COLLECTION AND MANAGEMENT 
 
Source Documents 
Source data includes all information in original records (and certified copies of original records) of clinical 
findings, observations, or other activities (in a clinical study) used for the reconstruction and evaluation of the 
study. Source data are contained in source documents (original records or certified copies) and are used to verify 
the authenticity of information recorded on the electronic Case Report Form (e-CRF).  Typical source documents 
can include CRFs, the hospital chart, medical office file, laboratory report, clinician notes, patient record, 
recorded data from automated instruments or other documentation prepared and maintained by the 
investigator/staff or ancillary services which contains a record of all observations and other data pertinent to the 
investigation on a study subject.   
The investigator is required to maintain original source documents at the site according to section 15.8 “Record 
Retention” procedure of this protocol.  Should an original source document (e.g., an instrument printout, direct 
entry CRF) need to be forwarded to the Sponsor for data entry, the site must retain a clearly designated certified 
copy.  The Study Monitor will confirm that procedures for copy certification have been established at the site 
prior to transmittal of any original source documents.  
 
Electronic Case Report Forms (eCRF) 
The electronic case report forms (eCRF) will be provided by the Sponsor.  The term “eCRF” as used in this 
protocol refers to eCRFs, or electronic case report forms for electronic data capture (EDC), as determined by the 
Sponsor.   
The Investigator may delegate eCRF completion to study personnel.  However, the Sponsor must be apprised in 
writing of the name of such persons and the scope of their authority.  The Investigator or designee is obligated to 
review each eCRF page and sign EDC, using an electronic signature.  An individual record will be kept for each 
subject that provided informed consent. 
Electronic CRF entries will be compared to source documents by the study monitor or designated personnel. 
Unless specified otherwise, all information on the CRFs must be traceable to original source documents.  
 
Electronic Source Data  
Specific procedures will be described in a study-specific Data Management Plan.  
 
Data Management and Storage 
Data Management will be performed by the Sponsor.  Electronic records entered at the site will be entered 
directly into the controlled database.  Data security is ensured through password protection, limited access, audit 
trails, and regular backups of the data. Upon completion of the study and verification of data, data will be 
screened for accuracy and completeness, after which the database will be locked from any additional changes.  
13.0 
STATISTICAL METHODS  
 
Sample Size Determination  
To evaluate the primary objective for HC analysis a sample size of at least 192 evaluable sites per study product 
arm (IP or RS) per body site can achieve > 95% power to pass HC analysis acceptance criteria for all four objectives 
using one-sample t-test (two-sided), with the following assumptions. 
 
Two-sided test Type I error (α): 0.05 
 
Standard deviation and mean log reduction: 

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Study Populations 
The full intent-to-treat (ITT) data set (all randomized subjects that received study product) will be used for the 
safety analysis. 
A modified intent-to-treat (mITT) data set will be used for efficacy analyses. Inclusion for the mITT data set is 
evaluated for each anatomical site (left and right for the groin and abdomen). For each anatomical site, if the product 
application day baseline bacterial count is in the range of 3.20 to 6.00 log10/cm2, inclusive, on the abdomen or 5.50 
to 7.50 log10/cm2, inclusive, on the groin, then the data from that anatomical site are included in the mITT data set. 
Analyses conducted on the mITT data set will also be conducted on the Per Protocol data set as supportive analyses 
when Per Protocol data are different from mITT data. 
The Per-Protocol data set will include evaluable product application sites from the mITT data set that adhere to 
defined assessments and procedures in the protocol central to patient enrollment, safety, rights or wellbeing, as well 
as the completeness, accuracy and reliability of study data. Additional details on qualification for the PP data set 
are outlined in the SAP. 
 
Handling of Missing Data 
Missing log10 CFU/cm2 determinations at 30 seconds, 10 minutes, or 6 hours, such as due to laboratory error or 
subject lost to follow up, will be reported as missing and will not be imputed. Inclusion of these subjects in the 
per-protocol data set will be based on the criteria defined above and within the SAP. Details of any missing data 
and rationale for inclusion/exclusion in the per-protocol data set will be described in the study report. 
 
For FDA analysis objectives: For log10 CFU/cm2 determinations, a tipping-point sensitivity analysis will use 
multiple imputation to impute a series of log10 CFU values relative to the baseline log10 CFU values for all missing 
data points in order to find the point at which the objectives at 30 seconds and 10 minutes would not be met. The 
multiple imputation will be performed separately for each of the 4primary and 2 secondary comparisons. 
For responder rate calculations from 6-hour data (FDA analysis), subjects with missing log10 CFU/cm2 
determinations at 6 hours will not be excluded from analysis. Missing data will be imputed by increasing the 
assumed number of failures sequentially from 0/M to M/M, where M is the number of missing data points at 6 
hours. This sensitivity analysis will be performed for all products on each anatomical site and will provide 
information on the possible effect of missing data on study results. 
Detailed description of sensitivity analysis performed will be described in the statistical analysis plan.  
 
Statistical Methods 
13.5.1 
HC Primary Analysis 
Log10 CFU/cm2 changes from baseline will be calculated separately for each subject, each of the four sites (left 
and right for the abdomen and groin), and each post-product application sampling time by taking the baseline 
log10 CFU/cm2 values and then subtracting the log10 CFU/cm2 values for the samples taken after baseline. The 
mean log10 CFU/cm2 changes from baseline will be calculated separately for the IP and the RS, at each anatomical 
site (abdomen and groin), and at each post-product application sampling time point (30 seconds and 6 hours).  
The following descriptive statistics for log10 CFU/cm2 reductions will be computed for the IP and RS, grouped by 
anatomical site and each post application sampling time point (30 seconds and 6 hours): mean, median, standard 
deviation, minimum, maximum, and count. The 95% confidence intervals (two-sided) will be calculated for the 
observed log reductions for the IP and RS at each time point on each anatomical area using one-sample t-test 
(two-sided).  
 

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The goal for the IP is that the mean log10 reduction meets the following criteria: 
 
The lower limit of the 95% confidence interval (two-sided) of mean log reduction at 30 seconds will 
be greater than or equal to 2 for the abdomen. 
 
The lower limit of the 95% confidence interval (two-sided) of mean log reduction at 30 seconds will 
be greater than or equal to 3 for the groin. 
 
The lower limit of the 95% confidence interval (two-sided) of mean log reduction at 6 hours will be 
greater than or equal to 2 for the abdomen. 
 
The lower limit of the 95% confidence interval (two-sided) of mean log reduction at 6 hours will be 
greater than or equal to 3 for the groin 
 
The RS should meet the same efficacy standards as the IP. 
13.5.2 
HC Exploratory Analyses 
1. 
The following descriptive statistics for log10 CFU/cm2 reductions will be computed for the 
IP and RS, grouped by anatomical site and each post application sampling for the 10 minute 
time point: mean, median, standard deviation, minimum, maximum, and count. The 95% 
confidence intervals (two-sided) will be calculated for the observed log reductions for the 
IP and RS at the 10 minute time point on each anatomical area using one-sample t-test 
(two-sided). 
2. 
Log10 CFU/cm2 reductions at 30 seconds, 10 minutes, and 6 hours on the abdomen and 
the groin for the IP will be compared to the RS using two-sample t-test (two sided). 
13.5.3 
FDA Primary Analysis  
A linear regression model for each body site (abdomen and groin) will be used for primary analysis of efficacy at 
10 minutes. In the model, the response is the post-product application bacterial counts at 10 minutes and 
predictors are the study products as a fixed effect and the pre-product application bacterial loads as a covariate. 
The ATE corrected for pre-product application bacterial loads will be estimated from the model and compared to 
both non-inferiority and superiority criteria. 
For assessment of the primary objectives (i.e., immediate activity at 10 minutes post application on the abdomen 
and groin):  
A non-inferiority criterion with a 0.5 log10 margin will be implemented for the average treatment effect 
(ATE) of the IP compared to the AC (i.e., the upper two-sided 95% confidence bound of the post-product 
application bacterial load corrected for pre-product application bacterial load of the IP – AC should be 
less than 0.5 log10). 
 
A 1.2 log10 superiority criterion will be implemented for the ATE of the IP compared to the NC (i.e., the lower 
two-sided 95% confidence bound of the post-product application bacterial load corrected for pre-product 
application bacterial load of the NC – IP should be greater than 1.2 log10). 
 
To evaluate the persistent antimicrobial properties of a single Swabstick impregnated with 2% (w/v) chlorhexidine 
gluconate in 70% (v/v) isopropyl alcohol, log10 bacterial counts at 6 hours post product application for each product 
application site will be converted to a binary (yes or no) success measure with success defined as having skin flora 
counts that are less than or equal to the baseline skin flora counts. Responder rates at 6 hours post product application 
will be summarized descriptively for each product on each body site.  No inferential analysis will be performed on 
the 6 hour time point data. 

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13.5.4 
FDA Secondary Analysis 
A linear regression model for the abdomen will be used for the analysis of efficacy at 30 seconds. In the model, 
the response is the post-product application bacterial counts at 30 seconds and predictors are the study products as 
a fixed effect and the pre-product application bacterial loads as a covariate. The ATE corrected for pre-product 
application bacterial loads will be estimated from the model and compared to both non-inferiority and superiority 
criteria. The FDA analysis secondary objectives will be evaluated only when the four co-primary objectives pass 
both non-inferiority and superiority criteria. 
For assessment of the secondary objective (i.e., antimicrobial activity at 30 seconds post application on the 
abdomen):  
1. 
A non-inferiority criterion with a 0.5 log10 margin will be implemented for the ATE of 
the IP compared to the AC (i.e., the upper two-sided 95% confidence bound of the post-
product application bacterial load corrected for pre-product application bacterial load of 
the IP – AC should be less than 0.5 log10). 
2. 
A 1.2 log10 superiority criterion will be implemented for the ATE of the IP compared to 
the NC (i.e., the lower two-sided 95% confidence bound of the post-product application 
bacterial load corrected for pre-product application bacterial load of the NC – IP should 
be greater than 1.2 log10). 
 
13.5.5 
FDA Exploratory Analysis 
Log10 reductions: 
The following descriptive statistics for log10 CFU/cm2 reductions will be computed for the IP, AC and NC at each 
anatomical site at 30 seconds, 10 minutes, and 6 hours post product application: mean, median, standard deviation, 
minimum, maximum, and count. 
Product weight expression: 
The weight (grams) of product solutions applied to an anatomical area will be estimated as: 
 
Product weight prior to product application (g) – product weight post-product application (g) 
 
The following descriptive statistics for expression weights will be computed for each product at each anatomical 
site: mean, median, standard deviation, minimum, maximum, and count.   
13.5.6 
Safety Analysis 
The statistical significance of differences in skin irritation between the study products at each post application 
sampling time will be evaluated by Fisher’s exact test on skin irritation data summarized for safety analysis as 
follows: any reaction above a zero (no reaction) on the skin irritation rating scale for any category (erythema, edema, 
rash, and dryness) will be considered a positive signal for that substance. If Fisher’s exact test shows statistically 
significant skin irritation between the study products, follow-up analyses will be conducted to determine how the 
reactions differ. No statistical analysis will be performed on the incidence of AEs. 
 
Demographics/Other descriptive information 
Demographics of the study population will be collected by the study sites and summary statistics for demographics 
will be performed. 

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14.0 
QUALITY CONTROL AND ASSURANCE 
 
Accountability of Study Products 
Investigational study products will be released only for use by Investigators who have obtained written IRB/EC 
approval (as required) for participation in this study, who have completed all required study documentation, and 
who have been qualified by the Sponsor.  Investigators must maintain control over all study products, and ensure 
they are used in accordance with this protocol.  Failure to do so may result in the Sponsor suspending or terminating 
the study at the Investigator’s site.   
The Investigator will ensure that study products are only dispensed to subjects properly enrolled in the study. The 
Investigator must maintain records of receipt, disposition, return and/or destruction of all study products. All 
investigational study products released to the site must be accounted for at the unit level prior to study close out, 
regardless of disposition.  The Study Monitor will regularly review all records regarding study product 
accountability.  
The Sponsor will maintain records that document the shipment, receipt, disposition, return and/or destruction of 
study products.  
 
Monitoring  
BD, the study sponsor, will designate trained and qualified personnel to monitor the progress of this study in 
accordance with BD Monitoring SOPs and the study-specific Monitoring Plan. 
Prior to study start, a study initiation visit will be conducted to provide training to site staff with regard to the 
protocol, the completion of study documentation and CRFs, the monitoring schedule, and all regulatory 
requirements. During the study, routine monitoring visits will be conducted to assure the site continues to adhere to 
the protocol, the investigator agreement, and regulations regarding conduct of studies.  Assessments will be made 
regarding the subjects’ protection and safety, when relevant, as well as the quality, completeness, and integrity of 
the data. The Study Monitor will assist the investigative site with query resolution and will perform site close-out 
activities once all queries have been resolved. 
Additional visits may be carried out depending upon site activity and performance. The Investigator must agree to 
the inspection of all study related records and give direct access to source documents for verification of data on 
CRFs.  
The Investigator is responsible for ensuring that any site-owned equipment required for use in the study is properly 
installed and maintained (e.g., inspected, calibrated, alarmed). Documentation of equipment maintenance 
procedures must be available for review by the Monitor.   
 
Audits and Inspections 
If the study is selected for audit by the Sponsor or if there is an inspection by the appropriate Health Authorities, 
then the Investigator and his team will make themselves available during the visit.  The Investigator must agree to 
the inspection of all study related records and give the auditor/inspector direct access to source documents for 
verification of data on CRFs.  The subject’s anonymity must be safeguarded and data checked during the audit 
remain confidential. 
As soon as the Investigator is aware of an upcoming inspection/audit by the Health Authorities, he/she will promptly 
inform BD.  As agreed with the Investigator, BD personnel may be present at the site during the inspection.  

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Protocol Deviations 
Protocol deviations are not permitted and should be implemented prospectively as a protocol amendment whenever 
practical or appropriate, unless required to protect the safety and well-being of the subject.  The Investigator must 
notify the Sponsor immediately of any such deviation resulting from the need to protect a subject.   
Protocol deviations (other than those required to protect the safety and well-being of a subject) may impact the 
evaluability of study data, and may place subjects at risk.   If the Investigator or their staff inadvertently deviates 
from the study plan, the Investigator should implement appropriate corrective and preventive procedures, and 
should notify the Sponsor at their earliest convenience.  Significant deviations may also need to be reported to the 
IRB/EC and local health authority.   
The Study Monitor will evaluate records of study conduct at the site to identify any deviations, and will also report 
them to the Sponsor and Investigator.  Upon evaluation by the Sponsor and Investigator, actions may be required 
to prevent additional deviations, such as retraining of the site, implementation of additional site procedures, and 
more frequent monitoring.  If these steps fail, more serious measures, up to and including termination of the site 
and withdrawal of study product may be necessary.   
15.0 
ETHICAL AND REGULATORY STANDARDS 
The study will be conducted in compliance with FDA regulations, the ethical principles of the Declaration of 
Helsinki (Fortaleza, Brazil; 2013), the Belmont Report, the International Conference on Harmonization (ICH) – 
Good Clinical Practice (GCP) Guidelines as currently amended, and all applicable SOPs at the study site. 
 
IRB/EC  
An appropriate IRB/EC must review this protocol, the Informed Consent Form, and any other supporting study 
documents which affect subject or study personnel safety, prior to study initiation at an investigational site. No 
investigational site may begin the study until the IRB/EC has given its written approval, signed by the IRB/EC 
chairperson or authorized personnel, and a copy of the approval letter and the approved Informed Consent Form 
has been provided to the Sponsor. 
 
Informed Consent 
Prior to giving informed consent, each candidate will have the opportunity to review the study procedures, risks and 
benefits and ask any questions he or she may have regarding the study. Before enrollment, each subject must give 
informed consent, documented by signing a written form, created and approved in compliance with 21 CFR Part 
50.25 and 21 CFR Part 56. Each subject should be given a copy of the signed informed consent document.  
 
Confidentiality of Data 
Subject confidentiality is strictly held in trust by the participating investigators, their staff, and BD and their agents.  
This confidentiality is extended to cover analysis of biological samples in addition to the information relating to 
participating subjects.  Subject confidentiality and anonymity will be maintained at all times by removal of all 
identifiers from any data, samples or documentation submitted for this study. 
Any data collected meeting the definition of protected health information will be collected and maintained using 
the designated authorizations and following all privacy procedures as specified in the applicable health authority 
regulations.   
BD will maintain the security and confidentiality of all study data sent to BD.  BD study databases will not be 
shared with any third party without the express written consent of the Investigator and/or Site. 

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The Study Monitor or other authorized representatives of BD may inspect all documents and records required to be 
maintained by the Investigator.  The Site will permit access to such records.  BD and the Site may be required to 
provide regulatory agencies access to study data and records, as well as source documents. 
All other agreements as to confidentiality by BD, the Investigator, and the Site may be found in the Confidential 
Disclosure Agreement and the study Trial Agreement. 
 
Protocol Modifications 
Amendments to the protocol will not be implemented without agreement from the Sponsor and prior submission to 
and written approval from the governing IRB/EC, except when necessary to eliminate an immediate hazard to the 
subject. Notice of an emergency modification shall be given to the Sponsor and the reviewing IRB/EC as soon as 
possible, but in no event later than 5 working days after the emergency occurred. Protocol amendments may affect 
Informed Consent Forms for current and future subjects. 
Minor changes to the protocol, such as correction of typographical errors or changes in personnel names (other than 
the Investigator) or contact information will be processed as administrative changes. Administrative changes will 
be submitted to the governing IRB/EC but implementation of the administrative change may proceed without prior 
IRB/EC approval, unless so required by the IRB/EC or site SOPs.  
 
Study Discontinuation 
BD reserves the right to temporarily suspend or prematurely discontinue the study at a single site or at all sites at 
any time and for any reason.  If such action is taken, BD will discuss the reasons with all Investigators (the 
Investigator).  If the study is terminated or suspended due to safety reasons, the sponsor will inform the health 
authorities as required, and provide the reason(s) for the action.  Investigator(s) must inform their IRB/EC promptly 
and provide the reason(s) for the suspension or termination. 
 
Study Registration 
In compliance with Title VIII of Public Law 110-85, known as FDA Amendments Act of 2007 (FDAAA), BD will 
register all applicable studies and disclose study results in a publicly accessible database.  Applicable studies will 
be registered no later than 21 days after commencing enrollment.  Study results for applicable studies will be posted 
to the website within 12 months of the last subject visit for collection of primary outcome data, or after health 
authority approval for previously unapproved products.  BD has responsibility for determining whether this study 
qualifies as an “applicable” study under the law, and if so, will take responsibility for registration and disclosure as 
required by law. 
 
Publication of Results 
BD believes that results of applicable studies of our products should be published in peer-reviewed literature in a 
timely, accurate, complete and balanced manner, regardless of study outcomes. BD is committed to making 
information public whenever it relates to the safety and efficacy of its marketed products. 
Any formal presentation or publication of data collected from this study will be considered as a joint publication by 
the investigator(s) and the appropriate personnel of BD. Authorship will be based on generally accepted criteria of 
the International Committee of Medical Journal Editors and determined by mutual agreement. For multi-center 
studies, the first publication will be based on data from all centers, analyzed as stipulated in the protocol by BD 
statisticians, and not based on data from single sites or a subset of sites. Investigators participating in multi-center 
studies agree not to present data gathered from one center or a small group of centers before the full, initial 
publication, unless formally agreed to by all other investigators and BD (the sole exception being an unanticipated 
AE that is product-related and which might have clinically significant safety implications for a marketed product 
or a class of products). 

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Record Retention 
The Investigator shall retain all essential study documents (e.g., IRB/EC approvals, signed informed consent forms, 
source documents, CRF copies, safety reports, study product dispensing records, etc.), for a minimum of 5 years 
after submission of study results, or 2 years after approval of application, or 2 years after study is completed, 
terminated, or discontinued, whichever is longer. BD will notify the Investigator(s)/institution(s) in writing, when 
the study-related records are no longer required. If the Investigator or Study Center withdraws from the 
responsibility of keeping the study records, custody must be transferred to a person or entity who will accept the 
responsibility.  BD must be notified in writing of the name and address of the new custodian. 
 
16.0 
BIBLIOGRAPHY/REFERENCES 
1. ASTM E1173-15, Standard Test Method for Evaluation of Preoperative, Precatheterization, or Preinjection Skin 
Preparations, ASTM International, West Conshohocken, PA, 2015. 
2. ASTM E 1054-08,  Standard Test Methods for Evaluation of Inactivators of Antimicrobial Agents, ASTM 
International, West Conshohocken, PA. 2013. 
3. Bretz F, Dmitrienko A. (Ed.), Tamhane A. (Ed.), Chow S. Multiple Testing Problems in Pharmaceutical Statistics. 
New York: Chapman and Hall/CRC. 2009s 
4. 21 CFR Parts 333 and 369 Tentative Final Monograph for Health-Care Antiseptic Drug Products; Proposed Rule, 
59 31450 § 116 (FDA, HHS 1994). Print. 
5. Health Canada. Final Guidance Document: Human-Use Antiseptic Drugs. December  2009. Accessed at: 
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-
submissions/guidance-documents/human-use-antiseptic-drugs.html. 
6. Food and Drug Administration (FDA). Safety and Effectiveness of Health Care Antiseptics; Topical 
Antimicrobial Drug Products for Over-the-Counter Human Use; Final Rule. December  2017. Accessed at 
https://www.gpo.gov/fdsys/pkg/FR-2017-12-20/pdf/2017-27317.pdf  
7. Williamson P., Kligman A.M. A New Method for the Quantitative Investigation of Cutaneous Bacteria. 
J. Invest. Dermatol. 1965;45: 498-503,. 
8. World Health Organization. WHO guidelines on hand hygiene in health care. 2009. 
9. Alex Dmitrienko, Ajit C.Tamhane, Frank Bretz Multiple Testing Problems in Pharmaceutical Statistics 
10. BS EN 12791:2016, Chemical disinfectants and antiseptics. Surgical hand disinfection. Test method and 
requirements (phase 2, step 2). 
 
 

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2.0 
Updated AE 
Relationship 
and 
Causality 
Description 
9.3 Assessment 
of Adverse 
Events (AEs) 
Before: 
Not Related: 
The AE is completely independent of study intervention 
administration, and/or evidence exists that the event is 
definitely related to another etiology. There must be an 
alternative, definitive etiology documented by the clinician. 
Unlikely Related: 
A clinical event, including an abnormal laboratory test 
result, whose temporal relationship to study intervention 
administration makes a causal relationship improbable (e.g., 
the event did not occur within a reasonable time after 
administration of the study intervention) and in which other 
drugs or chemicals or underlying disease provides plausible 
explanations (e.g., the participant’s clinical condition, other 
concomitant treatments). 
 
Likely Related: 
There is reasonable evidence to suggest a causal 
relationship, and the influence of other factors is less likely. 
The clinical event, including an abnormal laboratory test 
result, occurs within a reasonable time after administration 
of the study intervention, is less likely to be attributed to 
concurrent disease or other drugs or chemicals, and follows 
a clinically reasonable response on withdrawal (if 
applicable). 
 
Related: 
There is clear evidence to suggest a causal relationship, and 
other possible contributing factors can be ruled out. The 
clinical event, including an abnormal laboratory test result, 
occurs in a plausible time relationship to study intervention 
administration and cannot be explained by concurrent 
disease or other drugs or chemicals. The response to 
withdrawal of the study intervention should be clinically 
plausible. 
After: 
Not Related: 
The AE is independent of study intervention, and/or evidence 
exists that the event is related to another etiology. There must 
be an alternative, etiology documented by the clinician.  
Unlikely Related: 
A clinical event, whose temporal relationship to study 
intervention makes a causal relationship improbable (e.g., 
the event did not occur within a reasonable time of the study 
product use) and in which underlying disease provides 
plausible explanations (e.g., the participant’s clinical 
condition, other concomitant treatments). 
 
Likely Related: 
There is evidence to suggest a causal relationship, and the 
influence of other factors is less likely. The clinical event 
occurs within a reasonable time after use of the study 
product, and is less likely to be attributed to concurrent 
disease. 
 
Related: 
There is clear evidence to suggest a causal relationship, and 
other possible contributing factors can be ruled out. The 

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clinical event occurs in a plausible time relationship to use 
of the study product and cannot be explained by concurrent 
disease. 
 
2.0 
Updated 
subtitle to be 
consistent 
with product 
description 
Appendix 5 
Study Product 
Application 
Instructions 
Before: Investigational Product: 60% v/v 1-propanol and 0.9% normal 
saline 
 
After: Reference Standard and Negative Control: 60% v/v 1-propanol and 
0.9% normal saline   
 
2.0 
Updated 
subtitle 
numbering 
Appendix 6 
Neutralization 
Study 
Before: 6.2.1 Neutralizer effectiveness (Test1) and 6.2.2 Neutralizer 
toxicity (Test 2) 
 
After: 7.2.1 Neutralizer effectiveness (Test1) and 7.2.2 Neutralizer toxicity 
(Test 2) 
 
 

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18.0 
APPENDICES 
The following appendices are included: 
APPENDIX 1: Diagram of Anatomical Sites 
APPENDIX 2: Example Randomization Scheme 
APPENDIX 3: Subject Instructions for Neutralization Study 
APPENDIX 4: Subject Instructions for Main Study 
APPENDIX 5: Product Application Instructions 
APPENDIX 6: Neutralization Study 
 
 

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APPENDIX 2 EXAMPLE RANDOMIZATION SCHEME 
 
Randomization  
Number 
Subject  
Number 
Anatomical 
Area 
Product 
Code 
 Left Side 
Product 
Code  
Right Side 
Site 1 
Site 2 
Site 3 
Site 4 
R0001 
 
Ab / Groin / 
Both 
B 
C 
10 Minutes 
30 seconds 
Baseline 
6 Hours 
R0002 
 
Ab / Groin / 
Both 
A 
C 
10 Minutes 
Baseline 
30 seconds 
6 Hours 
 
R0003 
 
Ab / Groin / 
Both 
A 
B 
10 Minutes 
6 Hours 
Baseline 
30 seconds 
R0004 
 
Ab / Groin / 
Both 
D 
A 
30 Seconds 
10 Minutes 
Baseline 
6 Hours 
R0005 
 
Ab / Groin / 
Both 
B 
D 
Baseline 
10 Minutes 
6 Hours 
30 seconds 
R0006 
 
Ab / Groin / 
Both 
C 
D 
Baseline 
6 Hours 
10 Minutes 
30 seconds 
 
 
 
 

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APPENDIX 3 SUBJECT INSTRUCTIONS FOR NEUTRALIZATION STUDY 
 
SUBJECT INSTRUCTIONS FOR NEUTRALIZATION STUDY 
 
The following instructions are to be followed until the completion of the study 
o 
Use only the soap provided for all bathing, sponge bathing and hand washing. 
o 
Use only the shampoo provided when washing your hair. 
o 
Do not use antiperspirants or deodorants (other than those provided to you in the kit), lotions, 
colognes, perfumes, after shaves or powders. 
o 
Do not come in contact with strong detergents, acids, bases, solvents, bug repellant, fabric 
softener-treated clothing, UV treated clothing or other household chemicals in the in the 
abdominal body regions. 
o 
Do not swim in chemically treated pools or bathe in hot tubs, whirlpools or spas. 
o 
Do not use tanning beds. 
o 
Do not shave, use depilatories or hot waxes on the abdomen area.  If hair is present, allow study 
staff to clip hair at a designated time. 
o 
Do not apply any medicated creams or ointments to any area of your skin, nor should you take 
any antibiotics, systemic antimicrobials or steroids (other than hormones for contraception or post-
menopausal reasons), antihistamine medication. If these medications are necessary due to 
illness, please report this to 
 
 
 Resident Dermatologist at 
 
 immediately. 
 
Additional Instructions for Neutralization study dd/mm/yyyy  _ _ / _ _ / _ _ _ _ 
 
o 
You may be required to return to the Research facility approximatively 48 – 96 hours before 
Neutralization study for clipping / reclipping. 
o 
On the Neutralization study, you will return to the investigational site for products application and 
sampling. 
 
 
If you have questions about this study or in case of emergency, contact any time during business 
hours or/and after business hours: 
 
 RESIDENT DERMATOLOGIST 
 
 
 
 
 

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APPENDIX 4 SUBJECT INSTRUCTIONS FOR MAIN STUDY 
SUBJECT INSTRUCTIONS FOR MAIN STUDY 
 
The following instructions are to be followed until the completion of the study 
 
Use only the soap provided for all bathing, sponge bathing and hand washing. 
 
Use only the shampoo provided when washing your hair. 
 
Do not use antiperspirants or deodorants (other than those provided to you in the kit), lotions, colognes, 
perfumes, after shaves or powders. 
 
Do not come in contact with strong detergents, acids, bases, solvents, bug repellant, fabric softener-treated 
clothing, UV treated clothing or other household chemicals in the abdominal and upper thigh body regions. 
 
Do not swim in chemically treated pools or bathe in hot tubs, whirlpools or spas. 
 
Do not use tanning beds. 
 
Do not shave, use depilatories or hot waxes on the abdomen or upper thigh areas.  If hair is present, allow 
study staff to clip hair at a designated time. 
 
Do not apply any medicated creams or ointments to any area of your skin, nor should you take any 
antibiotics, systemic antimicrobials or steroids (other than hormones for contraception or post-menopausal 
reasons), antihistamine medication. If these medications are necessary due to illness, please report this to 
 Resident Dermatologist at 
 
immediately. 
 
Additional Instructions for Screening Day visit dd/mm/yyyy _ _ / _ _ / _ _ _ _ 
 
Do not bathe or shower in the 72-hour period before your scheduled appointment. A sponge bath may be 
taken, but avoid the areas of the lower abdomen, and/or upper thigh. 
 
You may be required to return to the investigational site approximatively 48 – 96 hours before your 
Screening visit for clipping / reclipping. 
 
On the day of the Screening visit, you will be required to return to the investigational site for the screening 
baseline sampling procedures. 
 
You will be contacted by telephone as to whether you have met the established criteria and therefore will 
be returning for a Product Application visit (if selected). Remember to continue to use your kit products until 
you have been eliminated or have completed the study. 
 
Additional Instructions for Product Application Day visit dd/mm/yyyy_ _ / _ _ / _ _ _ _ 
(if you are selected) 
 
Do not bathe or shower in the 72-hour period before your scheduled appointment. A sponge bath may be 
taken, but avoid the areas of the lower abdomen and/or upper thigh. 
 
You may be required to return to the investigational site approximatively 48 – 96 hours before your Product 
Application Day visit for clipping / reclipping. 
 
On the Product Application Day visit, you will return to the investigational site for products application and 
the initial sampling. 
 
You will be required to remain at the study facility through the 6-hours ± 30 minutes post-application skin 
sampling (as scheduled). You must limit physical activity and getting the product application sites wet during 
this time period. 
If you have questions about this study or in case of emergency, contact any time during business hours 
or/and after business hours: 
 RESIDENT DERMATOLOGIST 
          Phone: 
 
Mobile: 
 

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APPENDIX 5  STUDY PRODUCT APPLICATION INSTRUCTIONS 
 
Investigational Product: Single Swabstick   
Preparation 
1. 
Weigh the Swabstick package and record the weight.  
2. 
Remove the Swabstick from the package without touching the sponge tip. 
 
Product Application Site Application Instructions – Abdomen 
1. 
Place foam flat side down on the product application area. Using repeated back-and-forth 
strokes of the sponge for thirty (30) seconds, completely wet the product application area 
with the study product.  
2. 
Allow the area to air-dry for thirty (30) seconds. Do not blot or wipe away. 
 
Product Application Site Application Instructions – Groin  
1. 
Place foam flat side down on the product application area. Using repeated back-and-forth 
strokes of the sponge for two (2) minutes, completely wet the product application area with 
the study product.  
2. 
Allow the area to air-dry for one (1) minute. Do not blot or wipe away.  
 
Post-Product Application Instructions 
1. 
Weigh the Swabstick including package and record the weight.  
 
Active Control: ChloraPrep® SEPP®   
Preparation 
1. Weigh the ChloraPrep® SEPP® package and record the weight.  
2. Remove the ChloraPrep® SEPP® from the package without touching the applicator tip. 
 
Product Application Site Application Instructions – Abdomen 
1. 
Place sponge tip down on the product application area and pinch the barrel of the applicator 
only once to activate the ampule and release the antiseptic. Visualize that the foam is wet 
prior to starting application timer. Using repeated back-and-forth strokes of the sponge for 
thirty (30) seconds, completely wet the product application area with the study product.  
2. 
Allow the area to air-dry for thirty (30) seconds. Do not blot or wipe away. 
 
 

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Product Application Site Application Instructions – Groin  
1. 
Place sponge tip down on the product application area and pinch the barrel of the applicator 
only once to activate the ampule and release the antiseptic. Using repeated back-and-forth 
strokes of the sponge for two (2) minutes, completely wet the product application area with 
the study product.  
2. 
Allow the area to air-dry for one (1) minute. Do not blot or wipe away.  
 
Post-Product Application Instructions 
1. 
Weigh the SEPP applicator including package and record the weight.  
 
Reference Standard and Negative Control: 60% v/v 1-propanol and 0.9% normal saline   
Preparation 
1. 
Using a sterile pipette, transfer 1.75mL of 60% v/v 1-propanol or 0.9% normal saline into 
a suitable sized sterile Petri dish 
2. 
Weigh the Swabstick and the Petri dish containing 1-propranol or 0.9% normal saline and 
record the weight.  
3. 
Immediately prior to application, without touching the sponge tip, dip the Swabstick in the 
60% v/v 1-propanol or the 0.9% normal saline absorbing as much liquid as possible.  
 
Product Application Site Application Instructions – Abdomen 
1. 
Place foam flat side down on the product application area. Using repeated back-and-forth 
strokes of the sponge for thirty (30) seconds, completely wet the product application area 
with the study product.  
2. 
Allow the area to air-dry for thirty (30) seconds. Do not blot or wipe away. 
 
Product Application Site Application Instructions – Groin  
1. 
Place foam flat side down on the product application area. Using repeated back-and-forth 
strokes of the sponge for two (2) minutes, completely wet the product application area with 
the study product.  
2. 
Allow the area to air-dry for one (1) minute. Do not blot or wipe away.  
 
Post-Product Application Instructions 
1. 
Weigh the Petri dish and Swabstick and record the weight.  
 
 

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APPENDIX 6 NEUTRALIZATION STUDY 
 
1. Background 
The 
sampling 
solution, 
SS, 
 
 
 
 
  
 
 
 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 antimicrobials (chlorhexidine gluconate) 
present in the investigational product and active control. The effectiveness and toxicity of this neutralizer 
system must be assessed to demonstrate that there is no effect on the growth of microorganisms and that 
the active ingredient is inactivated. 
 
The density of normal human skin flora generally ranges from 102 to 105 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 this neutralizer system will be assessed against a lower bacterial concentration. 
 
This is a study where the study material is applied to the abdomen and the anatomical areas will be sampled. 
Each sample will then be processed using procedures in accordance with ASTM E1054-08(2013). Three 
samples will be taken from each anatomical area and one sample will be processed using Staphylococcus 
epidermidis (SE), ATCC 12228, a second sample using Staphylococcus epidermidis (MRSE) ATCC 51625, 
and a third sample using Methicillin-resistant Staphylococcus aureus (MRSA) ATCC 33592.  
 
2. Objective 
This control assay will determine the ability of the SS to completely neutralize the active ingredients in the 
study products when applied to the abdomen by recovering and quantifying microorganism populations on 
agar media and is appropriate for antimicrobial agents that can be chemically inactivated or diluted to sub-
inhibitory levels. Each test will be performed in triplicate, with the exception of Test 1 which will performed 
with N=6. 
 
3. Subject Entry Criteria 
Twelve subjects will be used for the neutralization validation required for this study.  Each subject must 
meet the inclusion criteria (1-6) listed in Section 4.1 and exclusion criteria (1-17) described in Section 4.2 
of the protocol with the exception of the 72-hour exclusion from showering/bathing and the length of the 
product restriction period. The product restriction period for neutralization is only necessary for 7 days (not 
14 days). The subjects will be asked to provide information on demographics and inclusion/exclusion 
criteria and sign the Consent and Authorization Forms before beginning the 7-day product restriction 
period. When the 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. The subjects will be identified by the letter “N” for neutralization and a subject number of 01 
to 12. 
 
The study material will be applied to bilateral areas of the abdomen so that six applications (n = 6) are 
performed for each of the 4 study products (a total of twelve subjects and 24 tests). Each anatomical site 
will have three sampling sites. 
 
 

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The test organisms for this study are: 
 
STAPHYLOCOCCUS EPIDERMIDIS (MSSE), ATCC 12228, MARKER ORGANISM 
 STAPHYLOCOCCUS EPIDERMIDIS (MRSE), ATCC 51625, MARKER ORGANISM 
 
METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) ATCC 33592, 
MARKER ORGANISM 
4. Study Products 
a. Investigational Product: Single swabstick impregnated with 1.75mL of 2% (w/v) chlorhexidine 
gluconate (CHG) in 70% (v/v) isopropyl alcohol (thermally treated)  
b. Reference Standard: 1.75 mL of 60% (v/v) 1-propanol applied with a swabstick 
c. Active control: ChloraPrep® SEPP® clear applicator-2% (w/v) chlorhexidine gluconate in 70% (v/v) 
isopropyl alcohol 
d. Negative control: 1.75mL 0.9% normal saline applied with a swabstick 
 
5. Randomization 
Subjects participating in the neutralization portion of the study will be randomized using a separate 
randomization schedule.  An example of the randomization schedule for the neutralization portion of the 
protocol is provided below. 
 
Randomization 
Number 
Subject 
Number 
Anatomical 
Area 
Left 
Right Site 1 
Site 2 
Site 3 
N001 
01 
Abdomen 
A 
B 
MSSE 
MRSA 
MRSE 
N002 
02 
Abdomen 
C 
D 
MRSE 
MSSE 
MRSA 
 
6. In-vivo Procedures (collection of samples) 
Anatomical area and post-product application sampling: Neutralization samples will be taken from the 
abdomen. Treatment sites and product application will utilize those for the groin area in the main study to 
simulate the maximum case scenario for product deposition to the treatment site. The subject number, 
location of the product application (left or right), location of the sites sampled within the anatomical area, 
and the time of sample collection will be documented on the CRF. The subject will be treated with the study 
materials based on the following: 
 
 
On one side of the body, mark the abdominal area using a sterile 1.3” x 5” (3.3 cm x 12.7 cm) template. 
The 1.3” x 5” (3.3 cm x 12.7 cm) will be delineated with three 1” x 1” sampling sites (one sampling 
site will be used for each test organism). 
 
After the anatomical area is marked, the area will be processed using three 70% isopropyl alcohol swabs 
for a total of one minute; the area will be allowed to dry. This step is to cleanse the skin for the 
neutralization test.  
 
Apply study product to the appropriate abdominal area for 2 minutes with a 1-minute dry time according 
to the instructions provided in Appendix 5 for the groin. 
 
Using the scrub cup technique at approximately 30 seconds post-product application (including dry 
time), begin collecting samples from each site using SS. This technique is described in Section 6.3.1.1. 
For the three sites within each 1.3” x 5” (3.3 cm x 12.7 cm) area; the samples will be collected 
simultaneously by three technicians. 

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 
Repeat on the bilateral application site with the second study product according to the randomization 
scheme. 
In-vitro Procedures [performed using the collected samples in accordance with ASTM E1054-
08(2013)] 
 
7.1  Inoculum Preparation: For each test organism, the organism will be prepared from an overnight broth 
culture (24 ± 4 hours) grown in TSB at 35° ± 2°C to yield a concentration of approximately 108 – 109 
CFU/mL. The culture will be diluted using PBW in a manner such that 30 – 100 CFU/mL will be 
delivered into the neutralizer tube (a 5 mL aliquot of the collected SS sample will be used).   
 
7.2 
Test: (note – the reference to investigational product applies to all study products; all procedures 
outlined, where applicable, will employ all study products. In addition, using the three samples taken 
within each 1.3” x 5” area; all procedures, as applicable, will be performed using one sample each 
for each of the three test organisms). 
 
7.2.1 
Neutralizer effectiveness (Test 1): 
 
a. Out of the 6.0 mL aliquot of sampling solution taken from the volunteer, 5.0 mL will be 
transferred to a new sterile tube and inoculated with the challenge microorganism so that 
the final concentration will equal 30 – 100 colony-forming units (CFU) /mL of the 
challenge microorganism (the prepared inoculum will be diluted using PBW to achieve the 
desired concentration, a 0.1-mL aliquot from the 10-4 dilution will be used). 
b. Within one min after the addition of the challenge microorganism, the microorganisms will 
be enumerated by standard microbiological methods extant in the laboratory.  
c. Triplicate 0.75 mL aliquots will be removed and plated using TSA+N pour plates. 
d. After 30 minutes, the microorganisms will be enumerated a second time using the same 
procedures. 
e. Triplicate 0.75 mL aliquots will be removed and plated using TSA+N pour plates. 
 
7.2.2 
Neutralizer toxicity (Test 2): 
 
a. A 5.0 mL aliquot of sampling solution will be inoculated with the challenge microorganism 
so that the final concentration will equal 30 – 100 colony-forming units (CFU) /mL of the 
challenge microorganism in the same manner as Test 1. 
b. Within one min after the addition of the challenge microorganism, the microorganisms will 
be enumerated by standard microbiological methods extant in the laboratory.  
c. Triplicate 0.75 mL aliquots will be removed and plated using TSA+N pour plates. 
d. After 30 minutes, the microorganisms will be enumerated a second time using the same 
procedures.  
e. Triplicate 0.75 mL aliquots will be removed and plated using TSA+N pour plates. 
f. This procedure will be repeated two times for a total of three replicates. 
 
 
 
7.2.3 
Test microorganism viability control (Test 3): 
 
a. A 5.0mL aliquot of PBW will be inoculated with a volume of the challenge microorganism 
so that the resulting suspension contains 30 – 100 CFU/mL in the same manner as Test 1. 
b. Within one min the microorganisms will be enumerated by standard microbiological 

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BD CONFIDENTIAL  
 
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methods extant in the laboratory. 
c. Triplicate 0.75 mL aliquots will be removed and plated using TSA pour plates. 
d. After 30 minutes, the microorganisms will be enumerated a second time using the same 
procedures.  
e. Triplicate 0.75 mL aliquots will be removed and plated using TSA pour plates. 
f. This procedure will be repeated two times for a total of three replicates. 
 
 
7.2.4 
Investigational Product control (Test 4): 
 
a. A 5.0mL aliquot of the Investigational Product will be inoculated with a volume of the 
challenge microorganism so that the resulting suspension contains 30 – 100 CFU/mL in 
the same manner as Test 1. 
b. Within one min the microorganisms will be enumerated by standard microbiological 
methods extant in the laboratory. 
c. Triplicate 0.75 mL aliquots will be removed and plated using TSA pour plates. 
d. After 30 minutes, the microorganisms will be enumerated a second time using the same 
procedures.  
e. Triplicate 0.75 mL aliquots will be removed and plated using TSA pour plates. 
f. This procedure will be repeated two times for a total of three replicates. 
 
 
7.3 
Incubation: 
All plates for Tests 1, 2, 3 and 4 will be incubated for 72 ± 4 hours at 30° ± 2°C. 
 
 
7.4 
Interpretation of data: 
a. The number of surviving challenge microorganisms for each replicate from each test will be 
average count of the triplicate plates and converted to CFU per mL. 
b. The number of survivor values will be transformed to log10. 
c. The number of survivors (log10) from each test (1, 2, and 4) will be compared to the test 
microorganism viability population (test 3). 
d. Neutralization aspects of the sampling solution will be considered adequate if the mean log10 
CFU/mL of Test 1 is not more than 0.20 log10 less than the mean log10 CFU/mL of Test 3 (Mean 
log10 CFU/mL from Test 3 – Mean log10 CFU/mL from Test 1 using corresponding time 
points). 
e. The sampling solution will be considered non-toxic if the mean log10 CFU/mL of Test 2 is not 
more than 0.20 log10 less than the mean log10 CFU/mL of Test 3 (Mean log10 CFU/mL from 
Test 3 − Mean log10 CFU/mL from Test 2 using corresponding time points). 
f. The mean log10 CFU/mL from Test 4 must be at least 0.20 log10 less than the mean log10 
CFU/mL of Test 3, with the exception of the NC 
g. All sterility controls must be negative for growth. 
h. The amount of CFU added for each aspect must be confirmed to yield a final suspension 
containing 30-100 CFU/mL (validated in test 3). 
 
7.5 
Controls: 
7.5.1 
Sterility Control 
Triplicate plates of TSA and TSA+N used will be incubated with the test. In addition, triplicate 1.0-mL aliquots of 
sampling solution and PBW will be plated using TSA pour plates used for a particular test date. All plates will be 
incubated with the test.  

Signature Page for MPS-17IPVSS02 Swabsticks Protocol v2 
Signature Page for MPS-17IPVSS02 Swabsticks Protocol v2 - System Version No. 4.0
Approved
 Senior Clinical Project Manager
07-May-2019 20:06:27 GMT+0000
Approved
 Medical Director
nagement
07-May-2019 20:59:19 GMT+0000
Approved
 Director, R&D
07-May-2019 21:38:21 GMT+0000
Approved
 Principal Statistician
n
08-May-2019 12:39:57 GMT+0000
Approved
 Medical Safety, VP
08-May-2019 14:20:20 GMT+0000