Efficacy of Meatal and Perineal Care With a Prepackaged Cleansing Cloth and Standardized Cleansing Protocol in Reducing Catheter-Associated Urinary Tract Infections in Acute-Care Hospitals
Phase: NA
Conditions: Catheter-Associated Urinary Tract Infection
Sponsor: Medline Industries

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Protocol Number: R17-019 
Efficacy of Meatal and Perineal Care with a Prepackaged Cleansing Cloth and 
Standardized Cleansing Protocol in Reducing Catheter-Associated Urinary Tract 
Infections in Acute-Care Hospitals 
 
 
 
December 19, 2019 
Version 5.0 
 
 
 
 
 
 
 
 
Aditi Mathur, PhD - 
Medline Industries, 
Inc. 
 
 
Digitally signed by Aditi Mathur, 
PhD - Medline Industries, Inc. 
Date: 2020.01.02 14:30:32 -06'00' 
 
Prepared by (Signature) 
Rosie D. Lyles, MD, MHA, 
Digitally signed by Rosie D. Lyles, MD, 
MSC 
MHA, MSC 
Date: 2020.01.03 16:45:37 -06'00' 
Date 
Reviewed by (Signature) 
Date 
Medline Industries, Inc. 
Three Lakes Drive 
Northfield, IL 60093 

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PRINCIPAL INVESTIGATOR STATEMENT OF COMPLIANCE 
• I agree to conduct the study in accordance with the relevant, current protocol and will make 
changes in the protocol only after notifying the Sponsor, except when necessary to protect the 
safety, rights, or welfare of subjects. 
• I agree to personally conduct and supervise the investigation as described within. 
• I agree to report to the Sponsor, IRB and/or Ethics Committee, according to the protocol, adverse 
experiences that occur during the course of the investigation in accordance with guidelines for 
Good Clinical Practices, and 21 CFR 812. 
• I have read and understand the information in the protocol, including the potential risks. 
• I agree to maintain adequate and accurate records in accordance with guidelines for Good 
Clinical Practices and 21 CFR 812.140 and to make those records available for inspection. 
• I will ensure that an IRB compliant with the requirements of guidelines for Good Clinical 
Practices and 21 CFR Part 56 will be responsible for the initial and continuing review and 
approval of the clinical investigation. I also agree to promptly report to the IRB all changes in the 
research activity and all unanticipated problems involving risks to human subjects or others. 
• I agree to comply with all other requirements regarding the obligations of clinical investigators 
and all other pertinent requirements in the guidelines for Good Clinical Practices, and the Code 
of Federal Regulations. 
 
 
I have received and reviewed this Investigational Plan. I will conduct the study as described. 
 
Principal Investigator (Print) 
Principal Investigator (Signature) 
Date 

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DOCUMENT HISTORY 
 
 
Version 
Date 
Description of Change 
Brief Rationale 
1.0 
19-Oct-2017 
Initial Release 
N/A 
2.0 
20-Mar-2018 
Section 4.1: Grammatical edit 
Grammatical edit 
Section 5.2: Add exclusion criteria 
Protect vulnerable populations (pediatric, pregnant, and 
psychiatric patients) and exclude Emergency Room, 
where catheter care is not routinely performed due to 
short length-of-stay in unit 
Sections 6.1 & 6.2: Revision to training 
procedures 
Explicitly states who will be trained, who is 
responsible for any training during study, and what 
materials and equipment will be provided. 
Section 6.3 & 9.1.3: Clarification on database 
access 
Clarification to indicate the sponsor may need access to 
the master linking list with participant IDs and names 
in the event of an Adverse Event or other situation. The 
database will still be housed at NorthShore. 
Section 6.3.1.1: a) Edits to data collection 
process, b) variables conducted and c) reference 
to the Case Report Form that can be found in 
Appendix 11.2. 
A) The use of REDCap for electronic CRF capture is 
no longer an option. Paper CRFs will be created to 
comply with regulatory requirements and then 
transferred to an electronic database. B) Certain 
variables could not be collected for the retrospective 
group, so these have been updated as well. C) A copy 
of the paper CRF is referenced in this section, and can 
be found in Appendix 11.2. 
Section 6.3.1.1.3: Edits to the process for 
collecting healthcare professional feedback on 
the product. 
Clarifies the process for data collection and stresses 
that participation is strictly voluntary with no impact on 
employment. A copy of the email that will be sent to 
potential participants is provided in Appendix 11.7. 

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Section 6.3.1.2: Edit to retrospective data 
collection process. 
Indicate that retrospective data will also be collected 
using the paper Case Report Form. 
Section 6.3.2: Edit to the compliance process 
Compliance will be measured via the internal audits 
rather than a count of all product used. 
Section 8.2.1: edit to statistical analysis plan and 
methods for primary endpoint 
Minor edits to provide more detail and clarity 
Section 8.2.3.1: Edit to analysis plan of 
healthcare professional feedback 
Indicate these data will be analyzed while study is 
ongoing 
Section 9.1.4: Edits to Personnel 
Inclusion of additional staff members 
Section 9.1.7.1: Edits to data management 
Change from REDCap system to paper Case Report 
Form system 
Appendix 11.5: Case Report Form replaces 
previous material. 
Case Report Form added now that data collection will 
be in paper form 
Appendix 11.6: Case Report Form for urine 
culture sub-analysis 
Provide separate Case Report Form for this portion of 
the study since it will only entail a small sub-sample of 
the study sample. 
Appendix 11.7: Sample e-mail to NorthShore 
employees for participation in feedback portion 
of study. 
Provide IRB with direct language for communication 
to NorthShore employees 
3.0 
31-Jul-2018 
Appendix 11.1.3 
Updated instructions for use for ReadyBath Intelligent 
Warmer as a different model is to be used for the study. 
4.0 
02-Jan-2019 
6.1: Events Prior to Intervention 
Clarify typographical error to Nurse Educators 
6.3.1.2: Retrospective Data Collection 
Clarify retrospective data collection to reflect that only 
in-depth details will be collected for subjects that 
developed a CAUTI 

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8.2.1: Primary Endpoint 
Modification of analysis plan due to change in data 
collected (modification took place before looking at 
data) 
Section 9.1.4: Key Roles and Study Governance 
Removed all titles and responsibilities for NorthShore 
and Sponsor Staff; only Principal Investigator 
information will remain. 
Section 9.1.7.1: Data Collection and 
Management Responsibilities 
Clarify CRF data collection for prospective and 
retrospective portions. 
5.0 
19-Dec-2019 
Months were replaced with catheter days. 
Changes in the timeline due to extension of the study. 
Addition in Section 6.3.2: Compliance with 
Intervention/Auditing. 
Updated the information in section 6.3.2 regarding 
second set (and subsequent, if required) of audits. 
Addition of Section 11.1.4: ReadyBath® 
Intelligent Warmer 
Included the older (section 11.1.3) and the newer 
(section 11.1.4) warmers, with their instructions for use 
(IFU), in this protocol. Some of the older warmers may 
be replaced with the newer version, as they 
malfunctioned and the manufacturer has discontinued 
the older warmer. 
Updating Section 7.2.1: Severity of event and 
Section 11.3: Adverse Event form 
Updated the Adverse Event (AE) form in section 11.3, 
such that the severity of all AEs will now be graded on 
a scale of one through five according to the most recent 
version of the Common Terminology Criteria for AEs 
guideline. These changes were also included in section 
7.2.1. Since no AEs were reported in the study so far, 
only the updated version of the AE form will now be 
used for reporting AEs, if any. 
Updating Section 11.4: Serious Adverse Event 
form 
Updated the Serious Adverse Event (SAE) form to 
highlight the steps that the study staff and Principal 
Investigator need to take in order to report any SAE 
during the  course of  the  study.  Since no  SAEs  were 

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reported in the study so far, only the newer version of 
the SAE form will now be used for reporting SAEs, if 
any. 

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TABLE OF CONTENTS 
1. PROTOCOL SYNOPSIS ................................................................................................................. 9 
2. INTRODUCTION ......................................................................................................................... 10 
2.1. 
Study Background and Rationale ........................................................................................... 10 
2.2. 
Risk/Benefit Assessment ........................................................................................................ 10 
3. OBJECTIVES AND ENDPOINTS ............................................................................................... 11 
4. STUDY DESIGN AND INTERVENTION .................................................................................. 12 
4.1. 
Overall Design ........................................................................................................................ 12 
4.2. 
Investigational Product ........................................................................................................... 12 
4.3. 
Control Group ......................................................................................................................... 13 
4.4. 
Study Intervention .................................................................................................................. 13 
5. STUDY POPULATION ................................................................................................................ 13 
5.1. 
Inclusion Criteria .................................................................................................................... 13 
5.2. 
Exclusion Criteria ................................................................................................................... 13 
5.3. 
Other Considerations .............................................................................................................. 14 
6. STUDY PROCEDURE ................................................................................................................. 14 
6.1. 
Events Prior to Intervention .................................................................................................... 14 
6.2. 
Wash-in Period/Educational Intervention .............................................................................. 14 
6.3. 
Intervention with ReadyCleanse® ...................................................................................................................................... 14 
6.3.1. 
Data Collection Procedures ................................................................................................. 15 
6.3.2. 
Compliance with Intervention/Auditing ............................................................................. 17 
7. SAFETY ASSESSMENT .............................................................................................................. 17 
7.1. 
Adverse Events and Serious Adverse Events ......................................................................... 17 
7.1.1. 
Definition of Adverse Events (AE) ..................................................................................... 18 
7.1.2. 
Definition of Serious Adverse Events (SAE) ..................................................................... 18 
7.2. 
Classification of an Adverse Event......................................................................................... 18 
7.2.1. Severity of Event .................................................................................................................... 18 
7.2.2. Relatedness of Event .............................................................................................................. 18 
7.2.3. Expectedness .......................................................................................................................... 19 
7.2.4. Relatedness of Event Time Period & Frequency of Event Assessment and Follow-Up ........ 19 
7.2.5. Adverse Event Reporting ........................................................................................................ 19 
7.2.6. Serious Adverse Event Reporting ........................................................................................... 20 

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8. STATISTICAL CONSIDERATIONS ........................................................................................... 20 
8.1. 
Sample Size Determination .................................................................................................... 20 
8.2. 
Statistical Analysis ................................................................................................................. 21 
8.2.1. 
Primary Endpoint ................................................................................................................ 21 
8.2.2. 
Secondary Endpoint ............................................................................................................ 21 
9. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS ................ 22 
9.1. 
Regulatory, Ethical, and Study Oversight Considerations ..................................................... 22 
9.1.1. 
Informed Consent Process .................................................................................................. 22 
9.1.2. Study Discontinuation and Closeout ...................................................................................... 23 
9.1.3. 
Confidentiality and Privacy ................................................................................................ 24 
9.1.4. 
Key Roles and Study Governance ...................................................................................... 25 
9.1.5. 
Safety Oversight .................................................................................................................. 25 
9.1.6. Clinical Monitoring ................................................................................................................ 25 
9.1.7. Data handling and Record Keeping ........................................................................................ 26 
9.1.8. Protocol Deviations ................................................................................................................ 27 
9.1.9. Conflict of Interest Policy....................................................................................................... 27 
9.2. 
Abbreviations.......................................................................................................................... 29 
10. 
REFERENCES ....................................................................................................................... 29 
11. APPENDIX .................................................................................................................................... 31 
11.1. Clinical Study Product ............................................................................................................ 31 
11.2. HCP Product Feedback Questionnaire ................................................................................... 35 
11.3. Adverse Event Form ............................................................................................................... 37 
11.4. Serious Adverse Event Form .................................................................................................. 38 
11.5. Case Report Form (CRF) ........................................................................................................ 41 

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1. PROTOCOL SYNOPSIS 
 
 
Title: 
Efficacy of Meatal and Perineal Care with a Prepackaged Cleansing Cloth 
and Standardized Cleansing Protocol in Reducing Catheter-Associated 
Urinary Tract Infections in Acute-Care Hospitals 
Study Description: 
A single-site, open-label, superiority study evaluating the efficacy of a 
prepackaged cleansing cloth and standardized cleansing protocol vs. current 
standard-of-care for catheter care and maintenance. 
Objective: 
Reduction in CAUTIs following implementation of prepackaged cleansing 
cloth and standardized cleaning protocol for all indwelling urinary catheter 
(IUC) care and maintenance, relative to current standard-of-care for the 
site. 
Endpoint: 
Incidence of CAUTI during intervention period compared to historical rate 
prior to intervention period. 
Study Population: 
Adult male and female patients who have an IUC inserted during their 
hospitalization at a northern suburban Chicago hospital system comprised 
of four acute-care hospitals. The study is powered to achieve a certain 
number of catheter days rather than participant number; prospective data 
collection will occur until all expected catheter days (42,672) have been 
completed. 
Phase: 
Post-market 
Description of 
Sites/Facilities 
Enrolling Participants: 
A hospital system composed of four acute-care facilities in the northern 
Chicago suburbs 
Description of Study 
Intervention: 
A pre-packaged, pH balanced, hypoallergenic cleansing cloth with a 
standardized cleaning protocol for IUC care and maintenance. 
Study Duration: 
The study will last until all expected catheter days (42,672) have been 
completed, and all data have been analyzed. 
Participant Duration: 
Participant duration will vary in length depending on how long they have 
an IUC inserted. 

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2. INTRODUCTION 
 
2.1. Study Background and Rationale 
 
Catheter-associated urinary tract infections (CAUTI) are one of the most common hospital-acquired 
infections (HAI), accounting for more than 15% HAIs in the United States.1 On October 1, 2008, the 
Centers for Medicare & Medicaid Services (CMS) stopped reimbursing hospitals for treatment of 
preventable HAIs.2 Subsequently, hospitals have implemented CAUTI prevention bundles to reduce 
these largely preventable, costly, and morbid infections. Guidelines for the prevention of CAUTI focus 
on the following four aspects of prevention: appropriate device utilization, aseptic insertion technique, 
proper care/maintenance of the catheter, and timely removal of the urinary catheter. 
 
Several interventions seeking to reduce CAUTIs have studied the impact of chlorhexidine gluconate 
(CHG) bathing in the intensive care unit (ICU) but have not found a significant effect.3-7 Though one 
study did find a significant reduction in high-level (>50,000 colony-forming units) candiduria and any 
level of bacteriuria with CHG bathing, the study did not evaluate the impact on CAUTI rates, nor did 
it investigate the effect of perineal care and maintenance following catheter insertion.8 Additionally, 
the expanded use of CHG carries with it the potential for development of CHG-resistant bacteria which 
could compromise its use for surgical site infection prevention. 
 
Few studies have exclusively investigated the effect of catheter care and maintenance on CAUTI rate. 
ReadyCleanse® meatal and perineal cleansing cloth by Medline Industries, Inc. (hereafter 
ReadyCleanse®) is a set of five prepackaged cloths including a gender-specific, five-step cleansing 
process clearly described on label that is designed to minimize transfer of bacteria to the patient during 
catheter care. Moreover, it does not contain ingredients that are bactericidal or bacteriostatic, thereby 
reducing the risk of compromising interventions such as CHG prior to surgery due to overuse. Thus, 
ReadyCleanse® provides an easy-to-use, efficient, and standardized means of conducting catheter care 
that may significantly reduce CAUTI rates compared to standard-of-care. 
 
2.2. Risk/Benefit Assessment 
 
ReadyCleanse® cloths are currently marketed products in the United States that are intended for 
meatal and perineal care, including when a patient has an indwelling urinary catheter (IUC) inserted. 
In this study, ReadyCleanse® cloths will be used strictly in accordance with their current labeling. 
ReadyCleanse® cloths were evaluated for safety through a repeat insult patch testing (RIPT) study in 
adults and a pediatric safety in use study. Based on the results of the RIPT study, it was concluded 
that ReadyCleanse® cloths did not have potential for eliciting dermal irritation or inducing 
sensitization.9 Based on the results of the pediatric safety in use study, it was concluded that 
ReadyCleanse® cloths did not demonstrate a potential to cause skin irritation for the study duration.10 
Taken together, the risk to patients through use of the ReadyCleanse® cleansing cloths is minimal. In 
terms of benefit, it is possible that patients in this study may directly receive a benefit. The majority 
of satellite hospitals within the main site currently use soap-and-water for their catheter care and 
maintenance, which has the potential to become contaminated and transfer bacteria to the patient, 

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especially when the cleansing is not done in a standardized, systematic way. If the use of 
ReadyCleanse® cloths and the cleansing process described on label does reduce CAUTI, as is 
hypothesized, many patients in the study may have had a CAUTI prevented. Additionally, the 
reduction of CAUTI with the use of ReadyCleanse® could further develop global best practices for 
catheter care and maintenance to avoid CAUTIs. In sum, the benefits in this study outweigh the 
minimal risk presented to participants in the study. 
 
3. OBJECTIVES AND ENDPOINTS 
 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
Evaluate 
if 
ReadyCleanse® 
cleansing cloths reduce CAUTI 
when used to perform catheter care 
and maintenance. 
The 
primary 
endpoint 
will 
be 
incidence of CAUTI, measured per 
1000 catheter days. The rate during the 
intervention will be compared to the 
historical rate for the facilities for the 
period preceding the intervention. 
This 
endpoint 
was 
chosen as it is a direct 
measure of the objective 
of the study, using well- 
accepted criteria. 
Secondary 
Evaluate if use of ReadyCleanse® 
cloths reduces bacteria counts in 
urine. 
This 
may 
provide 
a 
mechanistic 
account 
of 
any 
reduction in CAUTI. 
Number of colony forming units 
(cfu/ml) of bacteria in urine from a 
random sub-sample of participants in 
the intervention, compared to a 
random sample collected prior to the 
intervention beginning. 
This endpoint is a direct 
measure the objective, 
using 
well-accepted 
methodology. 
Exploratory 
Evaluate the financial impact of 
using ReadyCleanse® cloths as the 
standard-of-care for catheter care 
and maintenance. 
Cost savings in dollars through 
avoided CAUTIs, taking into account 
the cost of the product over the 
standard-of-care. 
Common measure of 
financial savings used 
in Health Economics 
Outcomes Research 
Gain feedback from healthcare 
professionals on the use of the 
product. 
Healthcare 
professionals 
who 
administer the intervention will be 
asked to fill out a questionnaire 
(Appendix 
11.2) 
about 
their 
experience with the product. Mean 
values from a four-choice scale will be 
computed for descriptive purposes. 
Common 
survey 
approach to eliciting 
feedback 
 
on 
preferences. 

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4. STUDY DESIGN AND INTERVENTION 
4.1. Overall Design 
 
This is an open-label, superiority study intended to determine if IUC care and maintenance with a 
prepackaged cloth and standardized cleansing process (ReadyCleanse® Meatal and Perineal 
Cleansing Cloth) can reduce CAUTI relative to standard-of-care. Four northern suburban Chicago 
acute-care hospitals, all within the same system (NorthShore University Health System), will 
implement ReadyCleanse® as the standard-of-care for catheter care and maintenance. An initial 
training period of six weeks will first occur, during which medical staff will be trained on the 
appropriate use of the product, and have several weeks to become accustomed to it. Following this 
six-week training period, data will be collected on incidence of CAUTI prospectively for the 
duration until all expected catheter days (42,672) have been completed. The incidence rate of 
CAUTI during the intervention period will be compared to the incidence rate for a similar number 
of catheter days prior to the six-week training period. A significant reduction in CAUTI rate during 
the intervention period will be taken as evidence of the ReadyCleanse® cloths and standardized 
cleansing process likely reducing CAUTI. The end of the study will coincide with the 42,672 
catheter days, at which point the study should be adequately powered (see Section 8). 
 
The choice of using a retrospective control was due to balancing the need for a high volume of 
catheter days in order to adequately power the study, and conducting the study in a reasonable 
timeframe (see section 8). During the intervention period, all four hospitals will continue using 
their baseline CAUTI bundle prevention measures, and no additional new interventions will take 
place during the study period. Also, given that this study is using the ReadyCleanse® cloths per 
their intended use and implementing the intervention simultaneously across the entire hospital 
system, it takes the form of a quality improvement initiative whereby the use of a retrospective 
control is commonly used. Nonetheless, conclusions drawn from this study will emphasize the 
intervention as a whole, such as staff training on how to use the cloths, instructions for how often 
to use the cloth, as well as the properties of the ReadyCleanse® cloths and standardized cleansing 
process, in order to make the appropriate conclusion given the known limitations of the use of a 
retrospective control. 
 
4.2. Investigational Product 
 
The intervention in this study will be the implementation of ReadyCleanse® cloths and the 
standardized cleansing process detailed on label as the new procedure for catheter care and 
maintenance across all four hospitals. This cloth is a currently marketed product which contains a 
pH-balanced, hypoallergenic solution. ReadyCleanse® cloths are specially designed for 
comprehensive meatal and perineal care to reduce the risk of developing a catheter-associated 
urinary tract infection (CAUTI). Each package contains five ReadyCleanse® cloths and a 
standardized cleansing protocol available on label. A copy of the product labeling and cleansing 
protocol is available in Appendix 11.1. Cleansing with ReadyCleanse® cloths and the standardized 
procedure will take place twice during a 24-hour period and after an incontinent episode. 

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4.3. Control Group 
 
A retrospective control group will be used to compare the efficacy of the intervention. The 
standard-of-care for catheter care and maintenance at NorthShore hospitals is soap-and-water 
cleansing. Thus, the ReadyCleanse® cloth and cleansing process will be compared to soap-and- 
water cleansing. The ICU of one of the hospitals recently switched to using a different method for 
catheter care. Consequently, data from this unit will not be added to the retrospective dataset, but 
this unit will participate in the intervention and have their prospective data pooled with the other 
units and hospitals. 
 
4.4. Study Intervention 
 
The study intervention will consist of two phases. An “Educational Intervention” will serve as a 
wash-in period and will take place in the first six weeks of the study; during this period of time 
clinical staff at all four hospitals will be trained on the proper usage of ReadyCleanse® and will 
gain experience using it in the clinical setting before data collection begins. The second phase will 
be a 42,672-catheter day-period, where data on CAUTI incidence will be collected while the 
ReadyCleanse® cloth and standardized process is in use for catheter care and maintenance. Figure 
4.1 depicts the flow of the intervention. 
 
Figure 4.1 
Wash- 
in 
Period 
ReadyCleanse® as standard care for all catheter care and maintenance at all four hospitals 
1.5 
2.5 3.5 4.5 5.5 6.5 7.5 8.5 9.5 10.5 11.5 12.5 13.5 14.5 15.5 16.5 17.5* 
Months 
*Study timeline may extend past 17.5 months. Study duration will be determined via completed 
catheter days (42, 672) 
 
5. STUDY POPULATION 
5.1. Inclusion Criteria 
 
• Any adult patient who requires an IUC to be placed during admission to one of the four 
study hospitals. 
 
5.2. Exclusion Criteria 
 
• Patients < 18 years old. 
• Patients whose entire hospital stay occurs in: 
o Pediatric unit 
o Psychiatric unit 
o Labor & Delivery or Postpartum units 

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o Emergency Room 
 
5.3. Other Considerations 
 
Given that this intervention will become the new standard-of-care with respect to catheter care and 
maintenance in the hospital system, as is appropriate given the product’s indications for use, we 
will not be screening participants (other than age), actively recruiting, or obtaining informed 
consent. All HIPAA rules will be strictly observed at all times in order to minimize any breaches 
of patient privacy and confidentiality (please see Section 9 for more details). 
 
6. STUDY PROCEDURE 
6.1. Events Prior to Intervention 
 
Clinical staff at the sites will receive training by a Medline Industries, Inc. Clinical Research 
Associate (CRA) and/or Clinical Product Specialist on the use of the ReadyCleanse® cloths and 
the standardized cleansing procedure prior to the start of ReadyCleanse® cloth use. Medline staff 
will offer training sessions to NorthShore health care providers who perform IUC routine catheter 
care (e.g. patient care technicians, staff nurses, etc.) during all shifts at each hospital to ensure 
effective and consistent use of the product. The training will also be offered to NorthShore Clinical 
Care Coordinators, Nurse Educators, and Study Research Nurses, along with NorthShore clinical 
research staff. Nurse Educators will be responsible for training newly hired personnel or any staff 
that could not attend the training sessions; Nurse Educators should document all training sessions. 
Training materials will be a combination of a Medline-produced product use video, review of 
ReadyCleanse® cloth package instructions, and pre-printed handouts. Medline staff members will 
be available to assist if any questions arise from the healthcare providers during the course of the 
study. ReadyBath Intelligent Warmers (Appendix 11.1), which are used to keep the 
ReadyCleanse® cloths warm to enhance patient comfort, will be placed on the floors. Positioning 
of the ReadyBath Warmers will be jointly determined by Medline and each of the four study 
hospital IPs in conjunction with the NorthShore research staff; in some instances it may not be 
possible to place ReadyBath Warmers due to spatial constraints. As the warming of the product is 
not essential to its efficacy, this is not anticipated to present a problem in interpreting the study 
results. 
6.2. Wash-in Period/Educational Intervention 
 
The first six weeks of the study will be dedicated to ensuring all staff members who perform 
catheter care and maintenance are adequately trained on the process of using the ReadyCleanse® 
cloths and to gain experience in using them. Training will take place as described in 6.1. Once 
trained, staff will begin using ReadyCleanse® cloths and the standardized cleansing process for 
perineal care. During this period, no data will be collected pertaining to the efficacy of the 
intervention. 
 
6.3. Intervention with ReadyCleanse® 

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Following the Educational Intervention, all hospital staff will be sufficiently trained in the use of 
ReadyCleanse® and the 42,672-catheter day-data collection period will begin. All participants 
requiring an IUC during their hospital stay will be considered enrolled in the study, and assigned 
a subject number. A master list linking subject numbers to patient name and medical record 
number will be maintained in a secure electronic database by the staff at NorthShore University 
Health System. This database will be maintained at the research site at all times. 
 
During this time, use of ReadyCleanse® cloths and the standardized cleansing procedure will be 
the standard-of-care for catheter care and maintenance; patients will undergo routine perineal care 
for a minimum of twice per day and after each incontinent episode. The specific cleansing 
procedure for ReadyCleanse® is provided in Appendix 11.1.2. 
 
6.3.1. Data Collection Procedures 
 
6.3.1.1. 
Prospective Data Collection 
 
During the data collection period, the Study Coordinator at the university health 
system will extract the relevant data from all patients who had an IUC during their 
hospital admission. Data will be extracted from the participant’s Electronic Health 
Record (EHR) in Epic (www.epic.com) and transferred into both an Excel 
spreadsheet and a paper Case Report Form (CRF) by NorthShore study staff; a 
sample of the CRF is provided in Appendix 11.5. The following data will be 
collected for each participant enrolled in the study and entered into his/her CRF: 
 
Demographic and general health information 
 
 Age 
 Gender 
 Race 
 Hospital within NorthShore system 
 Hospital room during stay 
 
Catheter related data 
 
 Admission date 
 Indication for IUC 
 Date catheter was placed 
 Date catheter was removed 
 Number of catheter days 
 Development of CAUTI 
 Adverse Event or Serious Adverse Event 
• Yes/No 
o If Yes, prompt to complete paper AE/SAE form 

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CAUTI data 
 
 Additional data will be collected on each participant who develops a CAUTI, 
including a urine culture. The full list of additional data collected on patients 
with a CAUTI is available sample CRF found in Appendix 11.5. This 
additional data collection is part of the standard practice within the NorthShore 
University Health System for anyone who develops a CAUTI. 
 
6.3.1.1.1. 
CAUTI Definition 
 
Patients will be deemed to have had a CAUTI using the criteria currently 
defined by the Centers for Disease Control (CDC), which can be found here: 
https://www.cdc.gov/nhsn/pdfs/pscmanual/7psccauticurrent.pdf 
 
6.3.1.1.2. 
Urine culture 
 
Quantitative urine cultures will be obtained from patients with IUC in-situ 
for at least 5-7 days. Twenty randomly selected IUC specimens will be 
obtained during the Educational Intervention period and another 20 samples 
during the study. Urine will be collected by the research coordinator from 
the IUC and transported to the research microbiology laboratory at 
NorthShore in a sterile, leak-proof container labeled with patient’s study ID 
number. 1ul and 10ul loops will be used to streak a blood agar plate and 
MacConkey agar plate. Both plates will be incubated at 35°C in a non-CO2 
incubator and inspected for growth of bacteria after 18-24 hours of 
incubation. Individual bacterial colonies will be identified using Matrix 
Assisted Laser Desorption/Ionization-Time of Flight (MALDI-TOF) mass 
spectrometry and quantity of organism calculated. The CRF specific to this 
portion of the study is provided in Appendix 11.6. Finally, all participants 
who develop a CAUTI will have a urine culture performed to determine the 
causative bacteria and susceptibility pattern. 
 
6.3.1.1.3. 
HCP Feedback 
 
Information pertaining to HCP acceptance of the product will be collected 
online in Survey Monkey; a link to the survey will be provided via e-mail. 
Appendix 11.2 provides the form that will be entered into Survey Monkey 
for HCPs to complete. This will take place approximately in Month 3 of the 
study. All participating HCPs will be sent an email (Appendix 11.7) asking 
them to fill out an anonymous survey. The survey will be used to gain 
feedback from HCPs on the use of the product. It will be stressed that the 

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survey is anonymous and the HCPs decision whether or not to participate 
will not affect their current or future status at NorthShore. Only one 
feedback survey questionnaire will be completed per HCP regardless of the 
amount of care provided. 
 
 
6.3.1.2. 
Retrospective Data Collection 
 
The CAUTI rate during the retrospective portion of the study is already collected; 
this rate will be compared to the CAUTI rate during the prospective portion of the 
study. Additionally, the CRF in 11.5 will be completed for any patient who had an 
IUC and developed a CAUTI in the similar number of catheter days as that of the 
intervention period, prior to the six-week training period. . These data will be 
extracted from the participants EHR from the sites electronic data warehouse and 
entered onto the CRF in the same fashion as the prospective data collection. Data 
from CRFs for participants in the retrospective arm will be transferred to the same 
electronic database as the prospective data for statistical analysis. 
 
6.3.2. 
Compliance with Intervention/Auditing 
 
During the study, random on-site observations of perineal care will be performed by 
research study coordinators. The study coordinators will directly observe the performance 
of perineal care for 10 IUC patients at each hospital and adherence to the written protocol 
will be determined. For sites that have adherence rates below the 90th percentile, we will 
acquire an additional 10 more observations to reduce the effect of sampling error. 
Observations of perineal care will be performed during the first seven months of the data 
collection portion of the intervention, with a goal that all audits are complete within three 
months. 
 
Due to extension of the study, the second (and subsequent, if required) set of audits will be 
executed by Medline Industries, Inc., in corroboration with NorthShore University Health 
System. 
 
7. SAFETY ASSESSMENT 
Given that the intervention in this study utilizes a low-risk product in accordance with its intended 
use and labeling, the safety risk to participants is minimal. Participants will be routinely monitored 
as they will be in the acute-care setting during the study, and will have their perineum and meatus 
inspected regularly for any signs of irritation. Adverse Events, as described below, will be collected 
for all participants and reviewed by the PI. 
 
7.1. Adverse Events and Serious Adverse Events 

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During this study, the ReadyCleanse® cloth will be used in accordance with its labeling 
and intended use, presenting minimal risk to the participants. Consequently, the 
definitions for Adverse Events and Serious Adverse Events listed below will be used in 
the course of this study. 
 
7.1.1. Definition of Adverse Events (AE) 
 
If the condition of the participant’s perineal skin and soft-tissue deteriorates unexpectedly, 
per the PI’s interpretation, or if there is a new condition that the PI determines is not related 
to the baseline health condition but could be related to the use of the study product, it will 
be recorded as an AE. 
 
7.1.2. Definition of Serious Adverse Events (SAE) 
 
Any AE that results in any of the following outcomes: Death, life-threatening event, 
requires or prolongs inpatient hospitalization, results in persistent or significant disability 
or incapacity, results in a congenital anomaly or birth defect, results in an important 
medical or event or requires medical intervention to prevent one of these outcomes. All 
AEs that are identified as per 7.1.1 will have Investigator determination of SAE and will 
have documented appropriate medical care for the event available in the EHR. 
 
7.2. Classification of an Adverse Event 
 
7.2.1. Severity of Event 
 
The severity of all adverse events will be graded on a scale of one through five according to the most 
recent version of the Common Terminology Criteria for Adverse Events guideline, where each grade 
represents a unique clinical description based on this general guideline: 
 
• Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observation only; 
intervention not indicated. 
• Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limited age- 
appropriate instrumental activities of daily living. 
• Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization 
or prolongation of hospitalization indicated; disabling; limiting activities of daily living 
involving self-care. 
• Grade 4: Life threatening consequences; urgent intervention indicated 
• Grade 5: Death related to AE 
 
7.2.2. Relatedness of Event 

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All adverse events (AEs) must have their relationship to study intervention assessed by the PI 
who examines and evaluates the participant based on temporal relationship and his/her clinical 
judgment. The degree of certainty about causality will be graded using the categories below. 
 
• Unrelated: This category applies to those adverse events which, after careful consideration, 
are clearly and incontrovertibly due to extraneous causes (disease, environment, etc.) 
• Possible: This category applies to those adverse events for which, after careful medical 
consideration at the time they are evaluated, a connection with the Investigational Product 
administration appears unlikely but cannot be ruled out with certainty. 
• Probable: This category applies to those adverse events which, after careful medical 
consideration at the time they are evaluated, are felt with a high degree of certainty to be 
related to the Investigational Product. 
• Definite: This category applies to those adverse events which, after careful consideration, are 
clearly and incontrovertibly due to the Investigational Product. 
 
7.2.3. Expectedness 
 
The PI will be responsible for determining whether an AE is expected or unexpected. An 
AE will be considered unexpected if the nature, severity, or frequency of the event is not 
consistent with the risk information previously described for the study intervention. One 
AE that may occur during the study is mild irritation at the cleansing site. 
 
7.2.4. Relatedness of Event Time Period & Frequency of Event Assessment and Follow-Up 
 
All AEs and SAEs will be captured on the appropriate reporting form. Information to be 
collected includes event description, time of onset, clinician’s assessment of severity, 
relationship to study product (assessed only by those with the training and authority to 
make a diagnosis), and time of resolution/stabilization of the event. All AEs and SAEs as 
defined in section 7.1 occurring while on study must be documented appropriately 
regardless of relationship. All AEs will be followed to adequate resolution. 
 
Changes in the severity of an AE will be documented to allow an assessment of the duration 
of the event at each level of severity. Changes in severity will necessitate a new CRF to 
document the new level of severity. AEs characterized as intermittent require 
documentation of onset and duration of each episode. 
 
The PI will record all reportable events with start dates occurring any time after the start of 
the Educational Intervention through the end of the study or resolution of the AE/SAE, 
whichever is later. 
 
7.2.5. Adverse Event Reporting 

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All non-serious AEs as per 7.1.1will be recorded on the Adverse Event form (Appendix 
11.3), and reported to the IRB as per IRB reporting requirements. 
 
7.2.6. Serious Adverse Event Reporting 
 
The study investigator shall complete an SAE Form (Appendix 11.4) and submit to the 
study sponsor and to the reviewing Institutional Review Board (IRB) as soon as possible, 
but in no event later than 48 hours after the investigator first learns of the effect. The study 
sponsor is responsible for conducting an evaluation of the SAE and shall report the results 
of such evaluation to the Food and Drug Administration (FDA) and to all reviewing IRBs 
within 10 working days after the sponsor first receives notice of the effect. Thereafter, the 
sponsor shall submit such additional reports concerning the effect as FDA requests. 
 
 
8. STATISTICAL CONSIDERATIONS 
8.1. Sample Size Determination 
 
The primary outcome will be measured as number of CAUTIs per 1000 catheter days. Given this 
type of data, a Poisson regression model will be used to model CAUTI incidence, with the 
dichotomous predictor variable pertaining to the intervention serving as the critical test for the 
hypothesis. To determine how many catheter days would be needed to adequately power the 
study, a power analysis was conducted using G*Power 3.1.9.2, with the following parameters: 
 
• Baseline CAUTI Rate: 0.89/1000 catheter days (entered as .00089/day) 
o Baseline rate reflects CAUTI rate for NorthShore University Health System in 2016. 
• Hypothesized reduction in CAUTI: 50% 
• Alpha: 0.05 (one-tailed) 
• Power: 80% 
• Mean Exposure: 1 day (the actual exposure will vary by participant, but entering 1 day 
can be used to determine number of catheter days rather than number of 
participants). 
• 
R2 other X: 0% 
• 
X distribution: Binomial 
• 
X parm Π: 0.5 
 
The result from this analysis indicated that 83,426 catheter days would be needed to adequately 
power the study at 80%. NorthShore Hospital University System averages approximately 
32,000 catheter days annually, which can be reduced to 2,667 per month. Thus, total number of 
catheter days required for collecting retrospective data and prospective data would be 85,344 
catheter days. The 42,672 (85,344-catheter days/2) catheter days of prospective data in 
comparison to a similar number of catheter days of retrospective data will provide data required 
for conducting the analysis. 

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8.2. Statistical Analysis 
8.2.1. Primary Endpoint 
 
The primary endpoint will be the comparison of CAUTI rates during the intervention period 
compared to the retrospective control period. This will be tested by modeling the likelihood 
of developing a CAUTI as a function of intervention status using Poisson regression, with 
the number of catheter days serving as the offset. A significant value for the parameter 
representing the intervention will serve as the test for the impact of the intervention. Formally, 
the hypothesis is: 
 
H0: β1 ≥ 0 
H1: β1 < 0 
 
Where β1 represents the beta-parameter for the dichotomous predictor variable pertaining to 
the intervention, with the retrospective control group coded as 0 and the prospective 
intervention group coded as 1. 
 
The 95% confidence interval for the incidence rate ratio will also be presented. 
 
Given that the retrospective and prospective portions of the study cover a significant period 
of catheter days, it is not expected that the two groups will vary on demographic variables or 
other key variables such as length-of-time the catheter is inserted, hospital unit during 
admission, etc. Thus, testing the incidence rate ratio will be sufficient for determining if a 
there is a significant difference in the CAUTI rate between the two time periods. 
 
In the event of over-dispersion of the data, negative binomial regression may be implemented 
to account for the over-dispersed data. Missing data on the primary endpoint is not anticipated 
to be a concern, given that government reporting requirements dictate that CAUTI rates be 
reported, which only requires an analysis of catheter days and number of CAUTIs. 
Participants who are discharged with an IUC or who expire during their admission will have 
their catheter days as well as any infections that occurred prior to discharge or death counted 
in the analysis. 
 
8.2.2. Secondary Endpoint 
 
The secondary endpoint will be an analysis of bacteria in the urine, comparing a random 
sub-sample of the study sample during the intervention to a random sub-sample of 
participants during the beginning of the Education Intervention. Samples of urine from the 
Education Intervention and those taken during the intervention will be compared in two 
ways. The number of individual bacterial species isolated from the cultures will be 
compared between the two groups, as well as cfu/ml of bacteria present, which will be 
quantified as follows: 

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1. No bacterial growth 
2. 100-500 cfu/ml 
3. 500-10,000 cfu/ml 
4. 10,000-50,000 cfu/ml 
5. 50,000-100,000 cfu/ml 
6. ≥100,000 cfu/ml 
 
Parametric or non-parametric measures, depending on the normality of the distribution, 
will be used to compare the two groups’ mean values on these two measures, with the 
hypothesis that use of ReadyCleanse® may reduce the amount of bacteria in the urine, 
providing a mechanistic account of how it may reduce CAUTI. 
 
8.2.3. Exploratory Endpoints 
 
8.2.3.1. 
Healthcare Professional Feedback 
 
The data analysis for the healthcare professional feedback survey in Appendix 11.2 
will be descriptive in nature. Survey responses will be assigned a numeric value, 
with “strongly disagree” = 1, “disagree” = 2, and so on. Mean values for each 
response will be calculated, and sub-analyses will be conducted stratifying the 
values by education, experience and age. These data will be collected 
approximately in Month 3 of the study. At the completion of the data collection, 
these data will be analyzed and may be presented externally. No other data from 
the study will be analyzed and no changes will be made to the study based on this 
feedback without a protocol amendment. As HCP feedback on the device in this 
setting is independent of whether the intervention reduces CAUTI, analyzing these 
data does not create an issue of multiple comparisons for the primary endpoint and 
therefore does not require p-value adjustment. 
 
8.2.3.2. 
Financial Analysis 
 
In order to investigate any financial savings from the use of ReadyCleanse®, we 
will undertake a financial analysis taking into account savings from avoided 
CAUTIs offset by the increased cost in using the ReadyCleanse® product and 
warmer as compared to soap-and-water. Government data on the estimated cost of 
a CAUTI will be used for these calculations. 
 
9. SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
9.1. Regulatory, Ethical, and Study Oversight Considerations 
 
9.1.1. Informed Consent Process 

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The intervention used in this study, ReadyCleanse® Meatal & Perineal Cleansing Cloth, is 
a currently marketed device with labeling and indication for use in meatal and perineal care 
as part of the standard catheter care and maintenance that occurs for all patients with 
urinary catheters. Consequently, this study entails minimal risk to the participant. 
Therefore, participant consent will not be obtained for this study. The addition of urine 
collection does not necessitate informed consent either, as the urine will be collected from 
the Foley catheter bag, which otherwise would have been discarded. As described in 
Section 9.1.3, all measures for protecting participant privacy and confidentiality will be in 
place. 
 
9.1.2. Study Discontinuation and Closeout 
 
9.1.2.1 Study Discontinuation 
 
This study may be temporarily suspended or prematurely terminated if there is 
sufficient reasonable cause. Written notification, documenting the reason for study 
suspension or termination, will be provided by the suspending or terminating party 
to the PI, sponsor, and IRB. If the study is prematurely terminated or suspended, 
the Principal Investigator (PI) will promptly inform the Institutional Review Board 
(IRB) and sponsor and will provide the reason(s) for the termination or suspension. 
 
Circumstances that may warrant termination or suspension include, but are not 
limited to: 
 
• Determination of unexpected, significant, or unacceptable risk to participants as 
determined by Adverse Event review 
• Insufficient compliance to protocol requirements 
• Data that are not sufficiently complete and/or evaluable 
 
The study may resume once concerns about safety, protocol compliance, and data 
quality are addressed, and satisfy the sponsor and/or IRB. 
 
9.1.2.2 Study Closeout 
 
Upon completion of the study, Medline and/or its designees will notify the site of 
closeout related procedures and will coordinate with the site the return of equipment 
and/or any unused ReadyCleanse® cloths. Medline CRA will communicate closely 
with the Investigator at that time point and will review all close out steps and 
materials. All study data, related study documents, unused study product, and 
warmers will be returned to the Sponsor. Sponsor will provide the facility with a 
summary of the activities and findings after the final analysis of the data has been 
completed. The site will also notify the IRB that the study has completed. 

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9.1.3. Confidentiality and Privacy 
 
Participant confidentiality and privacy is strictly held in trust by the participating 
investigators, their staff, and the sponsor. This confidentiality is extended to cover testing 
of biological samples in addition to the clinical information relating to participants. 
Therefore, the study protocol, documentation, data, and all other information generated 
will be held in strict confidence. No information concerning the study or the data will be 
released to any unauthorized third party without prior written approval of the sponsor. All 
study data and study records will be managed and stored in accordance with the site’s 
HIPAA compliant policies on data storage and security. All electronic transmission of data 
will adhere to HIPAA Security Rules. 
 
The study monitor, other authorized representatives of the sponsor, representatives of the 
Institutional Review Board (IRB), and regulatory agencies may inspect all documents and 
records required to be maintained by the investigator, including but not limited to, medical 
records (office, clinic, or hospital) and pharmacy records for the participants in this study. 
The clinical study site will permit access to such records. 
 
A master list linking subject numbers to patient name and medical record number will be 
maintained in a secure electronic database by the staff at NorthShore University Health 
System. This database will be maintained at the site at all times. The Sponsor may need 
access to the master list linking subject numbers to patient name in the event of an AE or 
other suitable event. Please note that this list will only contain information on the patients 
in the study who have indwelling urinary catheters; this does not refer to NorthShore 
employees participating in the healthcare worker survey described in Section 6.3.1.1.3. 
 
Participants of the healthcare worker survey will not be assigned a subject ID. They will 
be emailed a link to the survey provided in Section 11.2 and asked to participate; as 
indicated in Section 11.7, this email will convey that participation is strictly voluntary and 
no repercussions will occur should they choose not to participate. The only information 
provided to the Sponsor regarding the NorthShore employees will be that which they 
provide in response to the survey in 11.2. All of this information is de-identified to ensure 
privacy and confidentiality. 
 
The study participant’s contact information will be securely stored at each clinical site for 
internal use during the study. At the end of the study, all records will continue to be kept 
in a secure location for at least a period of two years, or longer if dictated by the reviewing 
IRB, Institutional policies, sponsor requirements, or ICH/GCP and FDA requirements. 
The PI will agree to notify sponsor of any intent to move or destroy these documents. 
 
Study participant research data, which is for purposes of statistical analysis and scientific 
reporting, will be maintained at the research sites. The research site will export summary 
files for statistical analysis to Medline Industries, Inc. These files will not include the 

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participant’s contact or identifying information. Rather, individual participants and their 
research data will be identified by a unique study identification number. The demographic 
data available on each participant (age, gender, and general clinical measures) will be 
generic enough as to not reveal the participant’s identity. The study data entry and study 
management systems used by clinical sites and by Medline Industries, Inc. research staff 
will be secured and stored in an access controlled locked drawer (any paper forms) and 
password protected (electronic records). At the end of the study, all study databases that 
are not already de-identified will be de-identified and archived at the Medline Industries, 
Inc. 
9.1.4. Key Roles and Study Governance 
 
Principal Investigator 
Kamaljit Sandhu Singh, MD, D(ABMM), Director, Microbiology & Infectious Disease 
Research 
NorthShore University Health System 
2650 Ridge Ave, Walgreens SB525 
Evanston, IL 60201 
847-733-5093 
KSingh@northshore.org 
 
9.1.5. Safety Oversight 
 
Given that this is a post-market study on a device used in accordance with its labeling, 
there is minimal safety risk to participants. Consequently, the PI will review AEs and SAEs 
regularly and make any necessary safety determinations as needed. 
 
9.1.6. Clinical Monitoring 
 
The CRA will confirm that the rights and well-being of subjects are protected, the 
reported trial data are accurate, complete, and verifiable from source documents, and 
will confirm the conduct of the trial by the Investigator and site is in compliance with 
the protocol, GCP, and regulatory requirements as well as any applicable institution or 
IRB and federal or local processes. Monitoring will occur at minimum every two months 
during the study duration or more frequently if: 
 
• The volume or quality of data is large or there is a backlog of review due to 
unexpected issues 
o This would also include any large volume of CRFs to be reviewed 
• The site compliance with the protocol or compliance with expected ICH/GCP 
and regulatory requirements is lacking or there are continuing unresolved 
compliance issues 
• There are unexpected AE/SAE or subject safety concerns noted 
• There are any unexpected inconsistencies with study product management 

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• There is a request for more frequent monitoring by the site 
• Any mutually agreeable situation as determined by NorthShore and Medline 
 
The frequency of routine monitoring may be increased to a longer interval after three 
monitoring cycles if on-site situations support this change. CRA will discuss this 
with Medline Associate Director or Clinical Manager and will inform the PI prior to 
implementation. 
 
Monitoring activities will include subject eligibility, source data review, CRF 
completion verification, product accountability, site continued suitability, PI study 
oversight, compliance, etc. and all general monitoring activities as outlined in FDAs 
Code of Federal Regulations and ICH/GCP guidelines that guide that activity. 
 
Medline may, on occasion, contract with external CROs to provide CRA services 
and those CRAs are authorized to act on behalf of Medline. 
 
It is expected that the site will be compliant with any institutional SOPs during the 
execution of the protocol and evidence of that compliance should be readily 
documented and verifiable by the CRA. 
 
The CRA will generate an internal Medline visit report that will be filed with the 
Medline trial master file and will provide the PI a detailed follow-up letter after each 
monitoring visit that will outline the completed monitoring activities as well as any 
identified areas of concern and the expected/applicable corrections needed. Medline 
reserves the right to perform audit of the study activities – either routine or for-cause 
– as needed and may also perform clinical monitoring audit as well. 
 
9.1.7. Data handling and Record Keeping 
 
9.1.7.1 Data Collection and Management Responsibilities 
 
Data collection is the responsibility of the clinical trial staff at the site under the 
supervision of the site investigator. The investigator is responsible for ensuring the 
accuracy, completeness, legibility, and timeliness of the data reported. 
 
All source documents of any kind (electronic, paper, etc.) should be completed in 
accordance with Good Documentation Practices (GDP) to ensure accurate 
interpretation of data. CRFs will be created for each subject for the prospective 
portion of the study. CRFs will be generated retrospectively only for patients that 
developed a CAUTI. The CRF for each subject will be populated from the subject’s 
EHR. The CRA will verify the data entered into the CRF with the site source 
regardless of the type of source. The site will be responsible for developing a 
written process that ensures the CRA is able view the source data. 

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Data from the CRFs will be entered by NorthShore study staff into a Microsoft 
Excel spreadsheet for statistical analysis. Data in the Excel database will be 
transferred to and analyzed with SAS, which allows for internal quality checks, 
such as automatic range checks, to identify data that appear inconsistent, 
incomplete, or inaccurate. Medline Industries, Inc. will be responsible for 
overseeing final data analysis and confirmation of results. 
 
9.1.7.2 Study Records Retention 
 
Study documents should be retained until at least two years have elapsed since the 
formal discontinuation of the study intervention or as required by any applicable 
FDA guidelines or for a longer period if required by local regulations. No records 
will be destroyed without the written consent of the sponsor, if applicable. It is the 
responsibility of the sponsor to inform the investigator when these documents no 
longer need to be retained. The Investigator is required to notify Medline if the 
location of the stored documents is changed after it is defined at the time of the 
Close Out Visit at study end. 
 
9.1.8. Protocol Deviations 
 
A protocol deviation is any noncompliance with the clinical trial protocol, International 
Conference on Harmonization Good Clinical Practice (ICH GCP), or Manual of 
Procedures (MOP) requirements. The noncompliance may be either on the part of the 
participant, the investigator, or the study site staff. As a result of deviations, corrective 
actions are to be developed by the site and implemented promptly. These practices are 
consistent with ICH GCP: 
 
4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3 
5.1 Quality Assurance and Quality Control, section 5.1.1 
5.20 Noncompliance, sections 5.20.1, and 5.20.2. 
 
It is the responsibility of the site investigator to use continuous vigilance to identify and 
report deviations on a routine basis. All deviations must be addressed in study source 
documents, and reported to Medline Industries, Inc. Protocol deviations must be sent to the 
reviewing Institutional Review Board (IRB) per their policies. The site investigator is 
responsible for knowing and adhering to the reviewing IRB requirements. A copy of the 
IRB reporting process for protocol deviations will be provided to the CRA by the site and 
will be filed with the site research materials related to the study. 
 
9.1.9. Conflict of Interest Policy 

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The independence of this study from any actual or perceived influence is critical. 
Therefore, any actual conflict of interest of persons who have a role in the design, conduct, 
analysis, publication or any aspect of this trial will be disclosed and managed. 

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9.2. Abbreviations 
 
AE 
Adverse Event 
CAUTI 
Catheter Acquired Urinary Tract Infection 
CDC 
Centers for Disease Control 
CFR 
Code of Federal Regulations 
CFU 
Colony Forming Units 
CHG 
Chlorohexidine gluconate 
CMS 
Center for Medicaid & Medicare Services 
CRA 
Clinical Research Associate 
CRF 
Case Report Form 
EHR 
Electronic Health Record 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HAI 
Hospital Acquired Infection 
HCP 
Healthcare Professional 
HIPAA 
Health Insurance Portability and Accountability Act 
ICH 
International Conference on Harmonization 
IRB 
Institutional Review Board 
IUC 
Indwelling Urinary Catheter 
PI 
Principal Investigator 
SAE 
Serious Adverse Event 
 
10. REFERENCES 
 
1. Klevens RM, Edwards JR, Richards CL, et al. Estimating health care-associated infections and 
deaths in US hospitals, 2002. Public Health Rep 2007; 122:160. 
2. Morgan DJ, Meddings J, Saint S, Lautenbach E, Shardell M, Anderson D, Milstone AM, Drees M, 
Pineles L, Safdar N, Bowling J, Henderson D, Yokoe D, Harris AD; SHEA Research Network. Does 
nonpayment for hospital-acquired catheter-associated urinary tract infections lead to overtesting and 
increased antimicrobial prescribing? Clin Infect Dis. 2012 Oct;55(7):923-9. Erratum in: Clin Infect 
Dis. 2013 Mar;56(6):911-2. 
3. Noto MJ, Domenico HJ, Byrne DW, et al. Chlorhexidine bathing and healthcare-associated 
infections. A randomized clinical trial. JAMA 2015; 313: 369–78. 
4. Rupp ME, Cavalieri RJ, Lyden E, et al. Effect of hospital-wide chlorhexidine patient bathing on 
healthcare-associated infections. Infect Control Hosp Epidemiol 2012; 33: 1094–100. 
5. Evans HL, Dellit TH, Chan J, Nathans AB, Maier RV, Cuschieri J. Effect of chlorhexidine whole- 
body bathing on hospital-acquired infections among trauma patients. Arch Surg 2010; 145: 240–46. 
6. Bleasdale SC, Trick WE, Gonzalez IM, Lyles RD, Hayden MK, Weinstein RA. Effectiveness of 
chlorhexidine bathing to reduce catheter-associated bloodstream infections in medical intensive care 
unit patients. Arch Intern Med 2007; 167: 2073–79. 

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7. Popovich KJ, Hota B, Hayes R, Weinstein RA, Hayden MK. Effectiveness of routine cleansing with 
chlorhexidine gluconate for infection prevention in the medical intensive care unit. Infect Control 
Hosp Epidemiol 2009;30: 959–63. 
8. Huang SS, Septimus E, Hayden MK, Kleinman K, Sturtevant J, Avery TR, Moody J, Hickok J, 
Lankiewicz J, Gombosev A, Kaganov RE, Haffenreffer K, Jernigan JA, Perlin JB, Platt R, Weinstein 
RA; Agency for Healthcare Research and Quality (AHRQ) DEcIDE Network and Healthcare- 
Associated Infections Program, and the CDC Prevention Epicenters Program. Effect of body surface 
decolonisation on bacteriuria and candiduria in intensive care units: an analysis of a cluster- 
randomised trial. Lancet Infect Dis. 2016 Jan;16(1):70-9. doi: 10.1016/S1473-3099(15)00238-8. 
9. Repeat Insult Patch Test with Re-Challenge Test (GCP), Final Report CRL104513, March 19, 2014. 
10. Pediatric Safety in Use Testing (GCP), Final Report CRL2016-0846, November 30, 2016. 

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11. APPENDIX 
 
11.1. 
CLINICAL STUDY PRODUCT 
 
Product Information 
Device Name: 
ReadyCleanse® Meatal and Perineal Cleansing Cloth 
Ingredients: 
Water (Aqua), Cocamidopropyl PG-Dimonium Chloride Phosphate, 
Glycerin, Phenoxyethanol, Benzoic Acid, Dehydroacetic Acid, 
Ethylhexyglycerin, Disodium EDTA, Polysorbate 20, Sodium Citrate, 
Aloe Barbadensis Leaf Juice, Simethicone 
Item Number(s): 
MSC095311 
Manufacturer: 
Medline Industries, Inc. 
11.1.1. Clinical Product Labeling 

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11.1.2. ReadyCleanse® Cloth Standardized Cleansing Protocol 
 

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11.1.3. ReadyCleanse® Cloth ReadyBath Intelligent Warmer 
 
 

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11.1.4 READYBATH® INTELLIGENT WARMER 
 
 

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11.2. 
HCP Product Feedback Questionnaire 
 
 
 

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Medline Industries, Inc. 
 
 
11.3. 
Adverse Event Form 
Site/Subject Information 
Study Sponsor: Medline Industries, Inc. 
Protocol Number: R17-019 
Site Number: 
Principal Investigator: 
Subject Number: 
Adverse Event Information 
# 
Adverse Event: 
Start 
Date: 
DD- 
MMM- 
YYYY 
Stop Date: 
DD-MMM- 
YYYY 
Frequency: 
Severity: 
Outcome: 
IP Lot #: 
Relation-ship 
to IP: 
Action 
Taken 
with IP: 
SAE Status: 
Comment: 
Form 
Completer 
nitials and Date 
Investigator 
nitials and Date 
Expected 
Yes* 
Unexpected 
No 
Expected 
Yes* 
Unexpected 
No 
Expected 
Yes* 
Unexpected 
No 
Frequency: 
Severity: 
Outcome: 
Relationship to IP: 
Action Taken with IP: 
SAE Status 
1 = Isolated 
2 = Intermittent 
3 = Continuous 
1 = Grade 1; mild 
2 = Grade 2; moderate 
3 = Grade 3; severe 
4 = Grade 4; life-threatening 
5 = Grade 5; death 
1 = Resolved, with no sequelae 
2 = Resolved, with sequelae 
3 = Unresolved 
4 = Death 
5 = Unknown 
1 = Not Related 
2 = Possible 
3 = Probable 
4 = Definite 
1 = None 
2 = Modified 
3 = Interrupted 
4 = Discontinued 
Death, life-threatening, prolonged hospitalization, 
significant disability/anomaly, medical intervention to 
prevent a serious outcome 
*In the event of a Serious Adverse Event, please complete the Serious Adverse Event Report form and 
send to Medline Industries, Inc. within 48 hours of awareness 
Printed name 
:  
 
Signature :  
 
Date:   
 

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11.4. 
Serious Adverse Event Form 
 
As soon as possible, but in no event later than 48 hours after becoming aware of the Serious Adverse 
Event. 
 
PLEASE DO ALL THE FOLLOWING: 
• 
E-MAIL THE COMPLETED REPORT(S) TO: ClinicalOperations@medline.com 
• 
Contact your study team CRA – See Medline Study Team Contact List in your Study Binder 
• 
Alert the listed name in your protocol in the Serious Adverse Event Reporting section 
• 
Add the Event details to the AE Log and update throughout the Event 
• 
Contact IRB as applicable 
 
Site Information 
Study Sponsor: Medline Industries Inc. 
Protocol Number: R17-019 
Site Number: 
Principal Investigator: 
Site Address: 
Report Type: 
(Check 
applicable type 
and submit a new 
form with any 
updates) 
☐ Initial 
☐ Follow-up number   
 
☐ Final 
Form Completed By: 
Title: 
Telephone: 
E-mail: 
Serious Adverse Event Information 
Subject Number: 
Subject Initials: 
☐ N/A 
Age: 
Gender: 
☐ Male 
☐ Female 
Investigational Product: 

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Event Description: (Please include a detailed description of the event in question, including the results of any 
laboratory/diagnostic imagery testing) 
Site Notification 
of the Event: 
Date Notified: 
Time Notified: 
Method of Notification: 
Event Start/Stop: 
Start Date: 
Stop Date: 
☐ Ongoing 
Event Qualifiers: 
(Check all that apply) 
☐ Death 
☐ Required Intervention to Prevent 
Permanent Impairment or Damage 
(Device) 
☐ Life-Threatening 
☐ Disability or Permanent Damage 
☐ Hospitalization - Initial or Prolonged 
☐ Congenital Anomaly/Birth Defect 
☐ Other Serious Important Medical Event: 
Relevant Medical History: 

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Concomitant Medication/Device History: (Please include historical information such as medication/device name, 
dosage, frequency, route, start date, etc.) 
Relationship to 
Investigational Product 
(IP): 
☐ Not Related (event definitely not related to IP, as judged by the Principal 
Investigator) 
☐ Possibly Related (event maybe related to IP, as judged by the Principal 
Investigator) 
☐ Related (event definitely related to IP, as judged by the Principal Investigator) 
Action Taken with 
Investigational 
Product: 
☐ Discontinued- Please Provide Date: 
☐ Interrupted- Please Provide Date: 
☐ None 
Comments: 
List of documents attached in support of the submission: 
☐ N/A 
Confirmation of Receipt: 
SECTION TO BE COMPLETED BY MEDLINE INDUSTRIES INC. 
Date Received: 
Time Received: 
Received By: 
Title: 

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11.5. 
Case Report Form (CRF) 
 
R17-019 Case Report Form 
Completed by: 
  
_ 
Demographic Information 
1. Participant Number: 
2. Age: 
3. Sex: Male  
Female  
4. Race (may select more than one): 
Black  White  Asian  Hispanic  
Other  
5. Hospital:  E:  G:  S: 
 H:  
6. Room Number: 
Study Data 
1. Admission Date: (DD-MMM-YYYY) 
2. Date of catheter insertion (DD-MMM-YYYY) 
3. Date of catheter removal (DD-MMM-YYYY) 
4. Number of catheter days: 
5. Indication for catheter: 
Open perineal wound:  
Urinary obstruction/retention:  
Pre- and Post-operative catheterization:  
Complicated Urologic procedure:  
Accurate measurement of urine output:  
Other:  
6. Did participant develop a CAUTI? (If yes, 
complete back side of form) 
Yes:  No:  
7. Did participant experience an AE or SAE (if 
yes, complete appropriate AE/SAE form) 
Yes:  No:  
Additional Data on Participants who Developed a CAUTI 
1. Date of CAUTI: (DD-MMM-YYYY) 
2. Patient arrived from: 
Home:  Hospital:  LTCF:  
3. Primary admission diagnosis: 
4. Did reason for catheter insertion meet CDC 
insertion criteria? 
Yes:  No:  
5. Did patient have fever > 100.4°F twice within 
48 hours ? 
Yes:  No:  

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6. Was patient’s white blood cell count ≥ 
12,000? 
Yes:  No:  
7. Did patient have flank pain? 
Yes:  No:  
8. Did patient have dysuria or frequency after 
catheter removal? 
Yes:  No:  
9. Date of urine culture (DD-MMM-YYYY) 
10. Reason for urine culture 
11. Did reason for urine culture meet criteria to 
take culture? 
Yes:  No:  
12. What organisms were identified from culture? 
13. What antibiotics were prescribed? 
14. Hand hygiene compliance for unit 

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11.6. 
Case Report Form: Urine Sub-Analysis 
 
R17-019 Case Report Form: Urine Sub-Analysis 
Completed by: 
  
_ 
Demographic Information 
1. Participant Number: 
2. Age: 
3. Sex: Male  
Female  
4. Race (may select more than one): 
Black  White  Asian  Hispanic  
Other  
5. Hospital:  E:  G:  S: 
 H:  
6. Room Number: 
Study Data 
7. Bacteria present in sample 
 
No growth 
 100-500 
cfu/ml 
 500-10,000 
cfu/ml 
 10,000-50,000 
cfu/ml 
 50,000-100,000 
cfu/ml 
 > 100,000 cfu/ml 
Organism(s) identified: 

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11.7. 
Sample E-mail Text for Questionnaire to NorthShore Employees 
 
Subject: Survey Regarding NorthShore Quality Improvement Study to Reduce CAUTIs using the 
Medline ReadyCleanse® cloths 
 
To whom it may concern: 
If you are receiving this e-mail, you have currently used the ReadyCleanse® wipe within your 
institution. As a reminder you are using this product as part of a 17.5-month IRB approved, Quality 
Improvement (QI) project to reduce CAUTIs at NorthShore University HealthSystem. The number of 
CAUTIs during the study period with ReadyCleanse® wipes, will be compared to the number of 
CAUTIs prior to the study beginning. All patients with an indwelling catheter are considered part of the 
study. 
 
The ReadyCleanse® package contains five individual cloths that correspond to a simple, five-step, 
cleansing protocol to help standardize the process of catheter care and maintenance at NorthShore. Upon 
completion of the use of this product, you will be asked to fill out an anonymous survey found at the 
corresponding link: https://www.surveymonkey.com/r/2KDRDZL. This survey will be used to gain 
feedback from healthcare professionals on the use of the product. Your decision whether or not to 
participate will not affect you current or future status at NorthShore. If you choose to complete this 
anonymous survey, you consent to participate. 
 
Thank you for your participation! If you have any questions please feel free to reach out to Dr. Kamaljit 
Singh. 
 
Medline Industries, Inc. 
3 Lakes Drive 
Northfield, IL 60093