A Randomized Trial to Determine if a Pre-operative Wash With a Chlorhexidine Cloth Reduces Infectious Morbidity in Patients Undergoing Cesarean Section
Phase: NA
Conditions: Chlorhexidine Gluconate Cloths, Infection; Cesarean Section, Infectious Morbidity, Surgical Site Infections, Endometritis
Sponsor: Icahn School of Medicine at Mount Sinai

A Randomized Trial to Determine if a Pre-operative Wash With a Chlorhexidine Cloth Reduces 
Infectious Morbidity in Patients Undergoing Cesarean Section  
PI: Dr. Joanne Stone 
NCT02402907 
Document Date: July 31, 2019 

 
Protocol Name: 
A randomized trial to determine if a pre-operative wash with a 
chlorhexidine cloth reduces infectious morbidity in patients 
undergoing cesarean section 
Principal 
Investigator/Contact 
Info:  
Joanne Stone, MD/joanne.stone@mssm.edu or x45681 
Primary Contact 
Name/Contact Info: 
Johanna Monro /johanna.monro@mssm.edu or x43888 
Date Revised: 
July 31, 2019 
Study Number: 
GCO#14-1410 
 
1 
Revised 9/2/14 
 
 
• Protocol Title 
A randomized trial to determine if a pre-operative wash with a chlorhexidine cloth reduces 
infectious morbidity in patients undergoing cesarean section 
• Investigator 
Joanne Stone, MD 
• Date Revised July 31, 2019  
• Study Number 
GCO#14-1410 
Brief Summary of Research (250-400 words):  
Surgical site infections (SSI) are the second most common cause of nosocomial infections. In 
obstetric patients, infectious morbidity (i.e. SSI, endometritis) occurs in 5-10% of cesarean sections, 
which is 5-fold higher than vaginal deliveries.  
Chlorhexidine, chemical antiseptic effective on gram positive and gram negative bacteria, reduces 
skin microflora/colonization but it is not clear if it decreases the risk of SSI. Chlorhexidine has both 
bactericidal and bacteriostatic mechanisms causing membrane disruption and is useful against fungi 
and viruses. 
There are no randomized studies evaluating interventions to reduce SSI in patients who undergo 
cesarean sections. 
The study will be offered to women who present for a scheduled primary or repeat cesarean 
section at Mount Sinai Medical Center. The eligible women will be randomized to use of a 2% 
chlorhexidine gluconate (CHG) cloth or placebo cloth (a fragrance free cleansing cloth) the 
night before and the morning of their scheduled procedure. Participants will be blinded to 
the arm in which they have been assigned. This study intends to show that the use of 2 CHG 
cloths prior to cesarean section will reduce the rate of SSI. 
1) Objectives 
The objective of this study is to determine if the use of chlorhexidine gluconate cloths prior to 
cesarean section reduce the rate of infectious morbidity (i.e. SSI, endometritis). 
2) Background 
Surgical site infections (SSI) are the second most common cause of nosocomial infections accounting 
for 15% of all nosocomial infections among hospitalized patients and 38% of nosocomial infections in 
surgical patients.  In obstetric patients, infectious morbidity (i.e. SSI, endometritis) occurs in 5-10% of 
cesarean sections, which is 5-fold higher than vaginal deliveries. SSI is costly, as evidenced by a two-

 
Protocol Name: 
A randomized trial to determine if a pre-operative wash with a 
chlorhexidine cloth reduces infectious morbidity in patients 
undergoing cesarean section 
Principal 
Investigator/Contact 
Info:  
Joanne Stone, MD/joanne.stone@mssm.edu or x45681 
Primary Contact 
Name/Contact Info: 
Johanna Monro /johanna.monro@mssm.edu or x43888 
Date Revised: 
July 31, 2019 
Study Number: 
GCO#14-1410 
 
2 
Revised 9/2/14 
 
 
fold increased risk of death from SSI.  Additionally, there is increased risk of SICU admissions and 
emergency room readmissions.  
Chlorhexidine is a chemical antiseptic that is effective against gram positive and gram negative 
bacteria and has been shown to reduce skin microflora/colonization.  However, it is not clear if it 
decreases the risk of SSI and other postoperative morbidities. Chlorhexidine has both bactericidal 
and bacteriostatic mechanisms causing membrane disruption and is also useful against fungi and 
viruses.  Further, chlorhexidine is thought to be more effective than other antiseptic agents because 
of its rapid action, persistent activity (even when exposed to bodily fluids i.e. blood), and residual 
lasting effect. 
Historically, chlorhexidine has been studied and used in orthopedic and cardiac implant surgeries. 
Research on the use of chlorhexidine for SSI prevention in cesarean sections is limited. The national 
average for birth by cesarean section is approximately 32.8% of all births, and the number of 
deliveries by cesarean section at Mount Sinai Medical Center is comparable. This study intends to 
evaluate the effectiveness of a preoperative chlorhexidine gluconate (CHG) cloth application and its 
potential effect in reducing SSI in patients undergoing cesarean section. Patients will be randomized 
to one of two groups: cloth application with a pre-operative CHG cloth at home on the night before 
and the morning of surgery (approximately 3 hours prior to the scheduled procedure) or application 
of a placebo cloth (a fragrance free commercial cleansing cloth). 
3) Setting of the Human Research 
Research will take place at Mount Sinai Medical Center. Patients will be recruited 2 days 
before their scheduled cesarean section during their pre-admission appointment on labor 
and delivery, 
 
 of the Klingenstein Pavillion at 1176 Fifth Avenue. 
4) Resources Available to Conduct the Human Research 
Researchers will have access to all patients scheduled for a cesarean section at Mount Sinai Medical 
Center. About 1800 deliveries by cesarean section occur each year at Mount Sinai. Of these, 
approximately 1000 are scheduled cesarean sections. Accordingly, there should be approximately 
1000 eligible patients per year. Based on our rate of SSI (6%) and the objective of a 67% decrease in 
SSI rates and expected rate of eligible patients who do not consent at 10%, 683 patients should be in 
each group for a total of 1365 participants.  We aim to recruit 683patients per group to account for 
patient drop out or non-compliance. 
 
Eligible study participants will be approached privately on the labor and delivery floor when they 
come to their pre-admission visit 2 days before their scheduled cesarean section. The nurse who 
sees patients at this visit will ask if she is interested in participating in the study. If she agrees the 

 
Protocol Name: 
A randomized trial to determine if a pre-operative wash with a 
chlorhexidine cloth reduces infectious morbidity in patients 
undergoing cesarean section 
Principal 
Investigator/Contact 
Info:  
Joanne Stone, MD/joanne.stone@mssm.edu or x45681 
Primary Contact 
Name/Contact Info: 
Johanna Monro /johanna.monro@mssm.edu or x43888 
Date Revised: 
July 31, 2019 
Study Number: 
GCO#14-1410 
 
3 
Revised 9/2/14 
 
 
nurse will notify a study team member to consent the patients and is not involved in the cesarean 
section surgery. 
Sage Products Inc, a healthcare product manufacturing company, will be providing the CHG cloths 
and the placebo cloths, commercial cleansing cloths. 
Each research staff member involved in this study has completed all training necessary to conduct 
human research and the research team has years of experience in clinical research and extensive 
experience conducting clinical research at Mount Sinai Medical Center. 
5) Study Design 
a) Recruitment Methods 
Eligible study participants will be approached for enrollment during their pre-admission testing 
visit at the Martha Stewart Center at MSH or the patient’s BPP visit at the MFM/OBGYN FPA 
practice at e E 98th Street.  
Once a patient is consented, she will be randomly assigned to one of the 2 arms of the study: the 
eligible women will be randomized to use of a 2% chlorhexidine gluconate (CHG) cloth or placebo 
cloth (a fragrance free cleansing cloth). Participants will be blinded to the arm in which they have 
been assigned.  
b) Inclusion and Exclusion Criteria 
The study will be offered to women at > 24 weeks gestation who are scheduled for a primary or 
repeat cesarean section. Exclusion criteria include allergy to chlorhexidine unplanned or 
emergency cesarean section.  
c) Number of Subjects 
We aim to enroll 1356 participants, 678 patients in each group. About 1800 deliveries by 
cesarean section occur each year at Mount Sinai. Of these, approximately 1000 are scheduled 
cesarean sections. Based on our rate of SSI (6%) and the objective of a 67% decrease in SSI rates 
and expected rate of eligible patients who do not consent at 10%, we plan to enroll 1356 patients 
in total to account for drop-outs or non-compliance. This number was modified last year based 
on our sponsor monitoring report in order to account for patients who delivered early or forgot 
to complete the pre-op wipe treatment. We currently have 1,338 enrolled and need 18 more for 
recruitment completion.   
d) Study Timelines 
After informed consent has been obtained, the duration of the subject 
participation will occur from the time they present for preoperative admission 

 
Protocol Name: 
A randomized trial to determine if a pre-operative wash with a 
chlorhexidine cloth reduces infectious morbidity in patients 
undergoing cesarean section 
Principal 
Investigator/Contact 
Info:  
Joanne Stone, MD/joanne.stone@mssm.edu or x45681 
Primary Contact 
Name/Contact Info: 
Johanna Monro /johanna.monro@mssm.edu or x43888 
Date Revised: 
July 31, 2019 
Study Number: 
GCO#14-1410 
 
4 
Revised 9/2/14 
 
 
testing until 6 weeks post procedure. We expect to complete enrollment by 
September 1, 2019 and complete data analysis by November 1, 2019.  
e) Endpoints 
The primary outcome will be SSI and postpartum endometritis. Secondary outcomes include 
other maternal complications or interventions, neonatal ICU admissions, maternal length of stay 
or readmissions.   
f) Procedures Involved in the Human Research 
This study intends to evaluate the effectiveness of a chlorhexidine gluconate (CHG) 
shower in reducing SSI in patients undergoing cesarean section. Patients will be 
randomized to one of two groups: administration of a 2% CHG cloth at home on the night 
before and approximately 3 hours prior to cesarean delivery on the morning of the 
surgery or cloth with the placebo (commercial cleansing cloth). Patients will receive a 
phone call, text message, and/or email reminder to apply the wipes (method of 
PrepCheck reminder will be decided by the patient). Currently, there is no wash or cloth 
used prior to cesarean section as a standard of care. 
Sage Products Inc will be blinding the study groups. The study team will be provided with 
pre-prepared packages that contain a 4 digit number indicating the product. Only Sage 
Products Inc will know which number indicates which group. Patients, recruiters, and 
statisticians will all be blinded. Once data has been analyzed, Sage Products Inc will 
inform the study teams as to which packages contain the CHG product number and which 
contain the placebo. 
Each patient will be assigned a unique identification code. The code will be linked to the 
name and date of birth in an encrypted password-protected linking key code file which 
will be stored on the PI’s personal network folder in the Hospital IT server, accessible by 
the PI only. The data will be stored in a separate password-protected database by the 
unique identification code. The database will be stored on a secure desktop at Mount 
Sinai hospital.   
There is minimal risk associated with the use of CHG in a surgical setting.  Use of CHG in 
surgery has been well described in the literature as safe with minimal risks. Enrollment in 
this study does not place a patient at increased risk over other patients undergoing a 
cesarean section. The only potential unforeseeable and minimal risk is an allergic reaction 
to the chlorhexidine gluconate. 

 
Protocol Name: 
A randomized trial to determine if a pre-operative wash with a 
chlorhexidine cloth reduces infectious morbidity in patients 
undergoing cesarean section 
Principal 
Investigator/Contact 
Info:  
Joanne Stone, MD/joanne.stone@mssm.edu or x45681 
Primary Contact 
Name/Contact Info: 
Johanna Monro /johanna.monro@mssm.edu or x43888 
Date Revised: 
July 31, 2019 
Study Number: 
GCO#14-1410 
 
5 
Revised 9/2/14 
 
 
Data collected will include demographic variables such as age, parity, BMI, race will be 
collected, as well as gestational age, number of previous cesarean sections, time from 
incision to delivery, type of anesthetic, and type of wound closure. Maternal outcomes 
including EBL, length of incision to delivery, length of operation, type of skin closure, type 
and use of prophylactic antibiotics, type of skin incision, type of skin closure, indication 
for cesarean, number of prior cesarean sections, and parity. Charts will be reviewed 
through the 6 week post partum visit in order to determine how well the skin at the 
incision site is healing. If patients do not visit Mount Sinai Medical Center for their 2 week 
wound check, they will be called and asked the following questions: Were you treated for 
wound infection? Did you experience wound separation or any other wound 
complications? 
g) Specimen Banking 
N/A 
h) Data Management and Confidentiality 
No specimens will be sent out or received in this trial. 
All data is de-identified; patients are followed by subject number. Identifiable patient 
information (consent forms & consent documentation) are kept separately from any data 
collected. All consent documentation is stored in a locked cabinet at 5 East 98th Street, 2nd Floor. 
Identifiable enrollment statistics are kept in a password-protected computer (Excel) spreadsheet 
that is only accessible by members of the research team on a departmental J Drive. 
Data will be analyzed on an intention to treat basis. Statistical analysis will be performed by SAS 
using X 2 test or Fisher exact test (categorical variables) and student t test or Mann-Whitney U 
test (continuous variables). Statistical significance will be set at p<0.05.  
i) Provisions to Monitor the Data to Ensure the Safety of Subjects 
Part I: Elements of a Data and Safety Monitoring Plan 
MSSM Principal Monitor: 
The principal monitor for this study is the PI:  
Last Name: Stone 
First Name: Joanne 
Academic Title: Professor 
Department:  OB/GYN – Maternal Fetal Medicine 
Mailing Address: 
 
 
 
 
Phone: 212-241-5681 

 
Protocol Name: 
A randomized trial to determine if a pre-operative wash with a 
chlorhexidine cloth reduces infectious morbidity in patients 
undergoing cesarean section 
Principal 
Investigator/Contact 
Info:  
Joanne Stone, MD/joanne.stone@mssm.edu or x45681 
Primary Contact 
Name/Contact Info: 
Johanna Monro /johanna.monro@mssm.edu or x43888 
Date Revised: 
July 31, 2019 
Study Number: 
GCO#14-1410 
 
6 
Revised 9/2/14 
 
 
Fax: 212-348-7438 
E-mail: joanne.stone@mssm.edu  
Dr. Joanne Stone has years of experience in research and clinical practice and is qualified to serve 
as the principal monitor to ensure the safety of participants. All adverse events, subject 
compliance with the protocol, drop outs, and all study data will be closely monitored and 
reviewed on an annual basis. 
Standard of care and labor floor protocol will be followed in order to ensure standard of care for 
all cesarean sections. 
If there is a temporary or permanent suspension of the study, in addition to the PPHS, the FDA 
and clinicaltrials.org will be notified. 
j) Withdrawal of Subjects 
There are no anticipated circumstances under which subjects will be withdrawn from the 
research without their consent. 
6) Risks to Subjects 
The risks to subjects are inherent to the cesarean section process itself outside of the study. The only 
difference in care is use of chlorhexidine gluconate in one arm of the study. This may result in a 
decreased rate of infection morbidity. 
If used as instructed, the only potential unforeseeable risk is an allergic reaction to the chlorhexidine 
gluconate. Allergic reaction could include itching or hives, swelling in your face or hands, swelling or 
tingling in your mouth or throat, chest tightness, and/or trouble breathing. 
The patients in our study are all scheduled for cesarean section by the patient’s physician.  The 
inherent nature of cesarean section requires an abdominal surgery.  As standard of care, all women 
in this study will be provided with analgesia.  In addition, enrollment in this study will not alter the 
current strategies regarding cesarean section. 
There is always the risk of loss of confidentiality; however, there are procedures in place to minimize 
this risk. To ensure confidentiality, the following system will be adhered to: When subjects are 
enrolled in this study, they will be assigned a unique identification code.  Corresponding medical 
record numbers for each code (key code) will be stored in a password locked document on the MFM 
server that can be accessed only by members of the research team. At the conclusion of the data 
extraction, the outcome variable will be assessed and the key codes to the medical record numbers 
will no longer be necessary and that information will be permanently erased from the key code file. 
Electronic data with identifiers will be encrypted according to Data Security Standards. 

 
Protocol Name: 
A randomized trial to determine if a pre-operative wash with a 
chlorhexidine cloth reduces infectious morbidity in patients 
undergoing cesarean section 
Principal 
Investigator/Contact 
Info:  
Joanne Stone, MD/joanne.stone@mssm.edu or x45681 
Primary Contact 
Name/Contact Info: 
Johanna Monro /johanna.monro@mssm.edu or x43888 
Date Revised: 
July 31, 2019 
Study Number: 
GCO#14-1410 
 
7 
Revised 9/2/14 
 
 
 
7) Provisions for Research Related Harm/Injury 
The patients will receive standard obstetric care and have access to the obstetric staff (physicians, 
nursing ) as well as all of the resources on the labor floor including the use of the ORs, blood bank, 
continuous fetal monitoring. Any potential adverse events are inherent to the operative delivery 
itself and regardless of the study.  Any complications that occur during cesarean section will be 
managed by the obstetricians and anesthesiologists. As standard of care, a physician is present 
during a cesarean section and is experience in managing complications. The patient is billed as per 
standard scheduled cesarean section regardless of complications due to the surgery. 
 
8) Potential Benefits to Subjects 
Direct benefit to subject is unknown. However, the potential benefit is that we may find a 
reduction in infectious morbidity related to the cesarean section surgery. 
9) Provisions to Protect the Privacy Interests of Subjects 
The patients will be approached by the nurse during pre-operative appointment to determine 
if they are willing to be included for randomization. Their participation will not require any 
additional examinations. All research-related discussions will be held in a private location. 
Any questions will be answered and fully discussed to maximize patient comfort.  If they 
choose to participate they will be randomized and receive care within the accepted 
standards.  If a patient must be called to find out how the wound is healing, the research 
team members placing the class will not leave a message or speak to anyone except the 
patient herself. When called, she will be asked if she can discuss the research study at that 
time, ensuring patient privacy and comfort. 
 
10) Economic Impact on Subjects 
There are no foreseeable costs that subjects may incur through participation in the research. 
11) Payments to Subjects 
There will be no payment to subjects. 
12) Consent Process 
The patient will be consented during the pre-operative appointment and informed consent will be 
obtained in a private location. As eligible participants had been scheduled for cesarean section prior 
to arrival, the patient’s doctor has already decided that this procedure is necessary and planned. A 
copy of the consent form will be available in referring doctor’s offices and the OB clinic, so that 
subjects will have some information about the study ahead of time, although consent will be 

 
Protocol Name: 
A randomized trial to determine if a pre-operative wash with a 
chlorhexidine cloth reduces infectious morbidity in patients 
undergoing cesarean section 
Principal 
Investigator/Contact 
Info:  
Joanne Stone, MD/joanne.stone@mssm.edu or x45681 
Primary Contact 
Name/Contact Info: 
Johanna Monro /johanna.monro@mssm.edu or x43888 
Date Revised: 
July 31, 2019 
Study Number: 
GCO#14-1410 
 
8 
Revised 9/2/14 
 
 
obtained at the time of pre-admission testing.  Study participants can  be English or Spanish 
speaking. Resources to translate the consent in Spanish are available. We will be following SOP HRP-
090 Informed Consent Process for Research. 
13) Process to Document Consent in Writing 
Consent will be documented in writing on the form. A copy of the signed informed consent 
will be placed in the patient’s chart along with a brief progress note indicating study 
enrollment with a brief discussion of the consent process. 
14) Vulnerable Populations 
Include 
Exclude 
Vulnerable Population Type 
 
X 
Adults unable to consent 
 
X 
Individuals who are not yet adults (e.g. infants, children, teenagers) 
 
X 
Wards of the State (e.g. foster children) 
X 
 
Pregnant women 
 
X 
Prisoners 
 
15) Multi-Site Human Research (Coordinating Center) 
N/A 
16) Community-Based Participatory Research 
N/A 
17) Sharing of Results with Subjects 
N/A 
18) External IRB Review History 
N/A 
19) Control of Drugs, Biologics, or Devices 
N/A