Tolerance of Chlorhexidine Gluconate Versus Povidone Iodine Vaginal Cleansing Solution: a Randomized Control Trial
Phase: PHASE4
Conditions: Surgical Preparation of the Vagina
Sponsor: Northwestern University

IRB #:  STU00204759 
 
 
1 
BIOMEDICAL PROTOCOL 
 
PROTOCOL TITLE:  Tolerance of Chlorhexidine Gluconate Versus Povidone Iodine Vaginal 
Cleansing Solution: a Randomized Control Trial 
 
PRINCIPAL INVESTIGATOR: 
Magdy Milad, MD 
Department of Obstetrics & Gynecology 
312-472-4655 
mmilad@nm.org 
 
VERSION NUMBER: 2 
VERSION DATE: 5/09/18 
 
STUDY SUMMARY: 
Title 
Tolerance of Chlorhexidine Gluconate 4%Versus Povidone 
Iodine 7.5% Vaginal Cleansing Solution: a Randomized Control 
Trial 
Short Title 
Tolerance of Chlorhexidine Gluconate Vaginal Cleansing 
Solution 
Protocol Number 
STU00204759 
Methodology 
Single-blinded Randomized Control Trial (patients blinded) 
Study Duration 
18 months 
Study Center(s) 
Prentice Women’s Hospital 
Objectives 
Compare the tolerance of 4% chlorhexidine gluconate /4% 
isopropyl alcohol versus 7.5% povidone iodine vaginal 
cleansing solutions in patients undergoing hysteroscopy, 
gynecologic dilation and curettage, endometrial ablation or 
Essure. 
Number of Subjects 
 Control (Povidone Iodine): 66 
 Experimental (Chlorhexidine Gluconate): 68 
Diagnosis and Main 
Inclusion Criteria 
Vaginal and urinary symptoms in women over the age of 
18undergoing hysteroscopy, dilation & curettage, endometrial 
ablation, and Essure 

IRB #:  STU00204759 
 
 
2 
Study Product(s), 
Route, Regimen 
4% chlorhexidine gluconate/4% isopropyl alcohol 
preoperatively 
 
 
OBJECTIVES: 
Objective: To compare the tolerance of 4% chlorhexidine gluconate/4% isopropyl alcohol 
versus povidone iodine vaginal cleansing solutions specifically for surgical preparations in 
patients undergoing hysteroscopy, dilation and curettage, endometrial ablation or Essure.  
 Specific Aim 1: To compare the frequency of patient-reported vaginal symptoms 
(dryness, burning, itchiness, unusual vaginal discharge) after treatment with 
chlorhexidine gluconate or  povidone iodine vaginal cleansing solutions.  
 Specific Aim 2: To determine the severity of vaginal symptom safter treatment with 
chlorhexidine gluconate or povidone iodine vaginal cleansing solutions. 
 Specific Aim 3: To determine the presence and severity of pain or burning with 
urination after treatment with chlorhexidine gluconate or povidone iodine vaginal 
cleansing solutions.   
Hypothesis: There will be no statistically significant difference between patient-reported 
vaginal and urinary symptoms after treatment with 4% chlorhexidine gluconate or 7.5% 
povidone iodine vaginal cleansing solutions.  
 
BACKGROUND: 
Surgical site antisepsis is critical in preventing surgical site infections. Although 
chlorhexidine gluconate has proven to be superior to povidone iodine for surgical site 
antisepsis, povidone iodine is the only FDA-approved antiseptic solution for surgical 
preparation of the vagina.1 Many surgeons are hesitant to use chlorhexidine gluconate for 
preoperative vaginal cleansing due to the alcohol dissolvent present in the solutions that is 
implicated in a greater risk of irritation. Yet, there has been no randomized study to 
illustrate whether the risk of vaginal irritation is greater in chlorhexidine gluconate versus 
povidone iodine. Thus, the purpose of the study is to conduct a randomized control trial to 
compare the tolerance of 4% chlorhexidine gluconate to povidone iodine using patient-
reported outcomes of vaginal and urinary symptoms.  
Currently, povidone iodine is the most frequently used antiseptic for surgical 
preparation of the vagina. Yet, povidone iodine is not optimal for preoperative vaginal 
cleansing. Data shows that two-minute vaginal disinfections lead to significantly elevated 
systemic iodine absorption.2 On the other hand, chlorhexidine covalently binds to mucosal 
proteins, leading to minimal systemic absorption.3 Furthermore, chlorhexidine has shown 
to have better reduction of bacterial flora after preoperative application, longer residual 
activity, and remains activated in the presence of blood or vaginal discharge.4 In a large 
prospective, randomized control trial across six different institutions, 4% chlorhexidine 
gluconate was shown to be more efficacious than povidone iodine for preventing surgical 
site infections in both superficial and deep incisional infections.5  
It is important to recognize both the risks and benefits of using chlorhexidine 
gluconate. Chlorhexidine gluconate has been used safely for over forty years, but 
manufacturers of chlorhexidine gluconate caution against using the product in genital 

IRB #:  STU00204759 
 
 
3 
areas as the solution can cause irritation and sensitization. A review of chlorhexidine 
hypersensitivity stated possible reactions include contact dermatitis, contact urticaria, and 
anaphylaxis.6 There has also been a case report of desquamating vaginal epithelium with 
chlorhexidine that resulted in the planned surgery being cancelled. The patient was treated 
with steroids, antihistamines, and topical estrogen and the vaginal mucosa was well healed 
within two weeks.7 One study conducted in South Africa looked at the tolerance and safety 
of different concentrations of chlorhexidine for peripartum vaginal washes. The study 
concluded that those receiving 4% chlorhexidine gluconate washes had more vaginal 
irritation than those receiving 1% or 0.25%.8 Nevertheless, another study showed that 
non-pregnant women were able to tolerate 4% chlorhexidine gluconate solution.9 In fact, 
the American Congress of Obstetricians & Gynecologists issued a committee opinion in 
2013, advocating that chlorhexidine gluconate with low concentrations of alcohol are both 
safe and effective for off-label use as surgical preparations of the vagina.10  
Currently, surgical site infections at Northwestern’s Prentice Women’s Hospital are 
higher than the national average. One way to combat this would be to use more effective 
preoperative antiseptic agents. Chlorhexidine gluconate is used for surgical preparation of 
the vagina in patients allergic to iodine, but its application can be far-reaching. The 
significance of the data from this proposed study will allow us to determine the tolerance of 
4% chlorhexidine gluconate compared to povidone iodine, and whether chlorhexidine 
gluconate is not only superior in its antiseptic properties, but also similarly or possibly 
more tolerable than povidone iodine.  
 
INCLUSION & EXCLUSION CRITERIA: 
Inclusion criteria: Women over age 18 who have the ability to understand and willingness 
to sign a written informed consent and are undergoing:  
1. undergoing hysteroscopy 
2. gynecologic dilation & curettage 
3. endometrial ablation 
4. Essure without concomitant laparoscopy  
Exclusion criteria: Women who are: 
1.  pregnant 
2.  have a history of atopic dermatitis, vaginal irritation, allergic reactions, or 
anaphylaxis to chlorhexidine gluconate or povidone iodine.  
 
STUDY ANALYSIS PLAN: 
The study will take place at a single site, Northwestern Prentice Women’s Hospital. Using a 
2-sided test to detect a difference between proportions with 80% power and a 5% 
significance level, and assuming the prevalence of irritation in the control group (povidone 
iodine) is 10% and prevalence of irritation in the exposed group (chlorhexidine gluconate) 
is 31%, and factoring in patients lost to follow up given that the data collection is through a 
survey, the study will need 68 participants in each group. There are an estimated 800 
hysteroscopies at Prentice Women’s Hospital each year and given incomplete follow-up, we 
estimate it will take 6 to 8 months of patient enrollment to achieve this desired sample size.  
 
STUDY-WIDE RECRUITMENT METHODS: 

IRB #:  STU00204759 
 
 
4 
The research coordinator will contact the appropriate gynecologic surgeons who will 
introduce the study to potential participants during the pre-operative office visit. On the 
day of surgery, prior to the administration of anesthetics, the patient will be asked of their 
willingness to participate in the study, and a study member will explain the risks and 
benefits. A written informed consent form will be filled out. Participants will be 
randomized through the use of Excel to generate randomization numbers to either 
experimental antiseptic, chlorhexidine gluconate, or the control, povidone iodine.  
 
STUDY TIMELINES: 
Participants will be involved in the study on the day of their surgery to 24-48 hours after 
surgery. 
The proposed timeline of the study can be seen below: 
- 
April- June 2017: Communicate with gynecologic surgeons operating at Prentice 
Women’s Hospital to gain awareness for the study. Communicate with preoperative 
nurses and operating room circulating nurses to make them aware of the logistics of 
study.  
- 
July-February 2018: Recruit and enroll patients. Administer patient surveys. 
- 
March- September 2018: Compile and analyze data 
 
STUDY ENDPOINTS:  
List of study variables to be collected:  
 
Outcomes 
Type 
Definition         
 
Vaginal dryness 
Ordinal 
Any sensation of dryness in the vagina 
Vaginal burning 
Ordinal 
Any sensation of burning in the vagina 
Vaginal itchiness 
Ordinal 
Any sensation of itchiness in the vagina 
Unusual vaginal 
discharge 
Ordinal 
Any witness of unusual discharge coming from 
the vagina 
Pain or burning with 
urination 
Ordinal 
Any sensation of pain or burning with urination  
  
Exposures 
Type 
Definition 
Pre-op chlorhexidine 
gluconate 
Dichotomous 
If women randomized to receive chlorhexidine 
gluconate, then yes. 
If woman randomized to povidone iodine, then 
no. 
  
Covariates 
Type 
Definition 

IRB #:  STU00204759 
 
 
5 
Woman’s Age 
Continuous 
Female age in years at time of surgery 
Surgery 
Nominal 
Hysteroscopy, dilation and curettage, 
endometrial ablation or Essure. 
  
Other 
Type 
Definition 
Use 
Gravidity 
Count 
Number of prior pregnancies 
Table 1 population 
characteristic 
Parity 
Count 
Number of pregnancies carried to 
a viable gestational age  
Table 1 population 
characteristic 
Race 
Categorical 
Group by race: White, 
Black/Africa-American, Hispanic, 
Asian/Pacific Islander, American 
Indian/Alaskan Native, Middle-
Eastern 
Table 1 population 
characteristic 
 
PROCEDURES INVOLVED: 
This is a single-blinded randomized control trial. The patients will be blinded to whether 
they receive the control povidone iodine or the experimental chlorhexidine gluconate 
antiseptic. The surgeons will be aware of the treatment, but will not be administering the 
survey questions to minimize bias.  
Given the nature of the procedures included in the inclusion criteria, participants 
will present to the hospital on the day of their surgery and most will be discharged two to 
three to hours after surgery. Participants are expected to respond to the survey pre-
operatively, prior to discharge from the hospital, and 24-48 hours after surgery. This 
corresponds to three total surveys per participant. The first two surveys done 
preoperatively and prior to discharge will be done on paper. A study member via phone 
will administer the third survey 24-48 hours after surgery. See Appendices 1 and 2 for 
sample pre-operative and post-operative surveys, respectively. The survey is six questions 
long, and should take no longer than 3-5 minutes to administer. The survey was designed 
using the PRO-CTCAE (Patient- Reported Outcomes version of the Common Terminology 
Criteria for Adverse Events) created by the NIH/NCI. The PRO-CTCAE is a measurement 
system used in cancer clinical trials to detect symptomatic adverse events. The language 
and format of the questions have been cognitively tested.11 Questions 1,4,5, and 6 are part 
of the PRO-CTCAE question bank. Questions 2 and 3 on the survey were investigator-
developed items to capture vaginal burning and itchiness, which are not contained in the 
PRO-CTCAE item library. 
The data to be collected will include: age, gender, race, gravidity, parity, surgeon, 
type of surgery, concomitant cystoscopy, use of Foley catheter, name of antiseptic solution, 
and presence and severity of vaginal and urinary symptoms based off survey responses. 
The patients will receive preoperative vaginal preparation either with povidone iodine or 

IRB #:  STU00204759 
 
 
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chlorhexidine gluconate. Both antiseptic solutions are approved for surgical preparation of 
the vagina at Northwestern’s Prentice Women’s Hospital. 
 
DATA & SPECIMEN MANAGEMENT: 
Paper data will be stored in a locked cabinet at the nursing desk of the preoperative 
holding area and periodically transferred to a password protected Excel file on a password-
protected laptop. Paper surveys will be stored for 1 years after the end date of the data 
collection (September 2019) and will be discarded through the hospital’s confidential 
document shredding service. Electronic data will be de-identified and stored indefinitely on 
a password-protected computer. 
The data will be transitioned to Excel and analyzed with a statistical software like 
SPSS. The participant’s MRN will be collected in order to link survey data with patient 
demographics and the corresponding surgery/vaginal cleansing intervention. This MRN 
will be matched to a participant ID, and the survey will only have the patient’s ID on it. The 
document linking MRN with participant ID will be kept separate from the surveys. The data 
collection spreadsheet will not contain patient MRNs.  
 
PROVISIONS TO MONITOR DATA TO ENSURE THE SAFETY OF PARTICIPANTS: 
The PI, Magdy Milad, and researchers, Supriya Rastogi, Laura M. Glaser, Jaclyn Friedman, 
and one other research coordinator will have access to the data. The study team will 
evaluate the data collected every 2 weeks, and look at any adverse events to ensure patient 
safety. Safety information will be collected with case report forms. The Principal 
Investigator will be notified within 24 hours of learning of any serious adverse events, 
regardless of attribution, occurring during the study. The office of Risk Management and 
the IRB will be notified as soon as possible of “any unanticipated problems involving risk to 
subjects or others” (UPR/UPIRSO).  
Contraindications: 
Contraindications include patient with a history of the following after use of chlorhexidine 
gluconate or povidone iodine in any application: 
- 
Atopic dermatitis 
- 
Vaginal irritation 
- 
Allergic reactions 
- 
Anaphylaxis  
The incidence of these events has not been studied specific to vaginal application. 
Special Warnings and Precautions for Use:  
There is a FDA warning of severe allergic reactions with chlorhexidine gluconate. 
Chlorhexidine gluconate continues to be used preoperatively as antiseptic agent at 
Northwestern operating rooms.  
Chlorhexidine Gluconate and Povidone Iodine 
- 
Do not use in contact with meninges, or over skin of head or face.  
- 
Stop use if irritation, sensitization, or allergic reaction occurs. 
- 
Keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if 
placed or kept in the eye during surgical procedures or may cause deafness when 
instilled in the middle ear through perforated eardrums. 
- 
If solution should contact these areas, rinse out promptly and thoroughly with water 

IRB #:  STU00204759 
 
 
7 
- 
Wounds which involve more than the superficial layers of the skin should not be 
routinely treated 
- 
Repeated general skin cleansing of large body areas should not be done except when 
the underlying condition makes it necessary to reduce the bacterial population of 
the skin. 
Interaction with other medications: 
No studies of interactions between chlorhexidine gluconate and povidone iodine and other 
drugs have been conducted.  
Adverse Reactions: 
The FDA reports the following possible side effects with the active medications  
Chlorhexidine Gluconate: 
- 
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the 
chest; swelling of the mouth, face, lips, or tongue). It is possible that some side 
effects of chlorhexidine gluconate have not been reported. 
Povidone Iodine: 
- 
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the 
chest; swelling of the mouth, face, lips, or tongue). It is possible that some side 
effects of povidone iodine topical may not have been reported.  
Adverse Event Monitoring: 
Adverse event data collection and reporting, which are required as part of every clinical 
trial, are done to ensure the safety of Subjects enrolled in the studies as well as those who 
will enroll in future studies using similar agents. Adverse events are reported in a routine 
manner at scheduled times during a trial. Additionally, certain adverse events must be 
reported in an expedited manner to allow for optimal monitoring of patient safety and care. 
The following events meet the definition of adverse event:  
1.     Any serious event (injuries, side effects, deaths or other problems), which in the 
opinion of the Principal Investigator was unanticipated, involved risk to subjects or others, 
and was possibly related to the research procedures. 
2.     Any serious accidental or unintentional change to the IRB-approved protocol that 
alters the level of risk. 
3.     Any deviation from the protocol taken without prior IRB review to eliminate apparent 
immediate hazard to a research subject. 
4.     Any new information (e.g., publication, safety monitoring report, updated sponsor 
safety report), interim result or other finding that indicates an unexpected change to the 
risk/benefit ratio for the research. 
5.     Any breach in confidentiality that may involve risk to the subject or others. 
6.     Any complaint of a subject that indicates an unanticipated risk or that cannot be 
resolved by the Principal Investigator. 
All other adverse events- such as those that are expected, or are unlikely or definitely not 
related to the study participation- are to be reported annually as part of regular data 
submission. 
 
WITHDRAWAL OF PARTICIPANTS: 
Participants will be withdrawn from the study without their consent if the patient 
experience anaphylaxis from either of the antiseptics, if the patient becomes pregnant, if 

IRB #:  STU00204759 
 
 
8 
the physician decides participation in the study is not in the patient’s best interest, and if 
the planned procedure is unable to be completed. These events will be recorded and stated 
when presenting data from the study. 
 
RISKS TO PARTICIPANTS: 
There are possible side effects to both chlorhexidine and povidone iodine. These include 
atopic dermatitis, vaginal irritation, allergic reactions, and anaphylaxis. There is a FDA 
warning of severe allergic reactions with chlorhexidine gluconate. Chlorhexidine gluconate 
routinely to be used preoperatively as antiseptic agent at Northwestern operating rooms. A 
review of anesthesia drug safety literature showed in patients who had allergic reactions 
after general anesthesia, chlorhexidine accounted for 5% of the allergies. Additionally, 
patch testing for chlorhexidine revealed a positive test in 2% of the participants suspected 
of contact allergic dermatitis exposed to chlorhexidine after topical application. It is 
estimated that this percent increases to greater than 5% in patients with atopic dermatitis, 
and thus patients with atopic dermatitis will be excluded in this study. 12In another study 
looking at 50 cases of allergic reactions to chlorhexidine, 9 were found to have 
anaphylaxis.13 In regards to povidone iodine, one study looked patients who had a rash 
after exposure to povidone iodine and found 10% to have a positive patch test.14 There 
have been multiple case reports of anaphylaxis to povidone iodine, but no particular 
statistic has been reported.15 The exact incidence of the adverse events of either antiseptic 
in the general population still remains unknown, as well the incidence of these events with 
vaginal application. 
 
 
POTENTIAL BENEFITS TO PARTICIPANTS: 
There is no direct benefit to participants.  
 
SHARING OF RESULTS WITH PARTICIPANTS: 
The results of the study are patient-reported outcomes. Patients will not be informed on 
the overall study results.  
 
SETTING: 
The research study will take place at Northwestern’s Prentice Women’s Hospital. Antiseptic 
procedures will occur at Prentice operating rooms prior to surgery.   
 
RESOURCES AVAILABLE: 
The study team will consist of the PI, Magdy Milad, and researchers, Supriya Rastogi, Laura 
M. Glaser, Jaclyn Friedman, and one other research coordinator. All study members will 
complete CITI training. The Principal Investigator is responsible for the conduct of the 
clinical trial at the site in accordance with Title 21 of the Code of Federal Regulations 
and/or the Declaration of Helsinki. The Principal Investigator is responsible for personally 
overseeing the treatment of all study patients. The Principal Investigator must assure that 
all study site personnel, including sub-investigators and other study staff members, adhere 
to the study protocol and all FDA/GCP/NCI regulations and guidelines regarding clinical 
trials both during and after study completion. 

IRB #:  STU00204759 
 
 
9 
The Principal Investigator will be responsible for assuring that all the required data 
will be collected and entered onto the Case Report Forms. Periodically, monitoring visits 
will be conducted and the Principal Investigator will provide access to his original records 
to permit verification of proper entry of data. At the completion of the study, all case report 
forms will be reviewed by the Principal Investigator and will require his final signature to 
verify the accuracy of the data. 
In obtaining and documenting informed consent, the investigator should comply 
with the applicable regulatory requirement(s), and should adhere to Good Clinical Practice 
(GCP) and to ethical principles that have their origin in the Declaration of Helsinki. 
 
CONFLICTS OF INTEREST: 
None to disclose.  All investigators will follow the University conflict of interest policy. 
 
PRIOR APPROVAL: 
The Department of Obstetrics & Gynecology has agreed to provide funding for this research 
project.  
 
ECONOMIC BURDEN TO PARTICIPANTS: 
Participants will not accrue any additional costs because of participation in the research.  
 
PROCESS TO DOCUMENT CONSENT IN WRITING: 
Before recruitment and enrollment onto this study, the patient will be given a full 
explanation of the study and will be given the opportunity to review the consent form. Each 
consent form will include all the relevant elements currently required by the FDA 
Regulations and local or state regulations. Once this essential information has been 
provided to the patient and the investigator is assured that the patient understands the 
implications of participating in the study, the patient will be asked to give consent to 
participate in the study by signing an IRB‑ approved consent form. 
 
Prior to a patient’s participation in the trial, the written informed consent form will 
be signed and personally dated by the patient and by the person who conducted the 
informed consent discussion. 
 
DRUGS OR DEVICES: 
Both povidone iodine and 4% chlorhexidine gluconate vaginal cleansing solutions are 
available at Northwestern Prentice Women’s Hospital operating rooms. The solutions will 
be stored, handled, and administered according to the current operating room guidelines. 
Package inserts for both antiseptics are shown below:  
 
4% Chlorhexidine Gluconate Solution/4% isopropyl alcohol:  
 
Purpose 
Antiseptic 
Uses 
• 
Surgical hand scrub: significantly reduces the number 
of microorganisms on the hands and forearms prior 
to surgery or patient care 
• 
Healthcare personnel handwash: helps reduce 

IRB #:  STU00204759 
 
 
10 
bacteria that potentially can cause disease 
• 
Patient preoperative skin preparation: for the 
preparation of the patient's skin prior to surgery 
• 
Skin wound and general skin cleansing 
 
Warnings 
For external use only 
Do not use:  
• 
If you are allergic to chlorhexidine gluconate or any other 
ingredients 
• 
In contact with meninges 
• 
In the genital area 
• 
As a preoperative skin prep of the head or face  
When using this product: 
• 
Single use when used for patient preoperative skin 
preparation 
• 
Keep out of eyes, ears and mouth. May cause serious and 
permanent eye injury if placed or kept in the eye during 
surgical procedures or may cause deafness when 
installed in the middle ear through perforated ear drums. 
• 
If solution should contact these areas, rinse out promptly 
and thoroughly with water 
• 
Wounds which involve more than the superficial layers of 
the skin should not be routinely treated 
• 
Repeated general skin cleansing of large body areas 
should not be done except when the underlying condition 
makes it necessary to reduce the bacterial population of 
the skin 
Stop use and ask a doctor if irritation, sensitization or allergic 
reaction occurs. This may be signs of a serious condition.  
Keep out of reach of children. 
If swallowed, get medical help or contact a Poison Control Center 
right away. 
 
- 
Do not use in contact with meninges, or over skin of head 
or face.  
- 
Stop use if irritation, sensitization, or allergic reaction 
occurs. 
- 
Keep out of eyes, ears, and mouth. May cause serious and 
permanent eye injury if placed or kept in the eye during 
surgical procedures or may cause deafness when instilled 
in the middle ear through perforated eardrums. 
- 
If solution should contact these areas, rinse out promptly 
and thoroughly with water 
- 
Wounds which involve more than the superficial layers of 
the skin should not be routinely treated 

IRB #:  STU00204759 
 
 
11 
- 
Repeated general skin cleansing of large body areas 
should not be done except when the underlying condition 
makes it necessary to reduce the bacterial population of 
the skin. 
- 
There is a FDA warning of severe allergic reactions with 
chlorhexidine gluconate.  
- 
 
 
Directions 
Use with care on premature infants or infants under 2 months of 
age. These products may cause irritation or chemical burns 
Surgical hand scrub: 
• 
Wet hands and forearms with water 
• 
Scrub for 3 minutes with about 5 mL of product with 
and a wet brush, paying close attention to the nails, 
cuticles and interdigital spaces 
• 
A separate nail cleaner may be used 
• 
Rinse thoroughly 
• 
Wash for an additional 3 minutes with 5 mL of 
product and rinse under running water 
• 
Dry thoroughly 
Healthcare personnel handwash: 
• 
Wet hands with water 
• 
Dispense about 5 ml of product into cupped hands 
and wash in a vigorous manner for 15 seconds 
• 
Rinse and dry thoroughly 
Patient preoperative skin preparation: 
• 
Apply product liberally to surgical site and swab for 
at least 2 minutes and dry with a sterile towel 
• 
Repeat procedure for an additional 2 minutes and dry 
with a sterile towel 
Skin wound and general skin cleansing: 
• 
Thoroughly rinse the area to be cleaned with water 
• 
Apply the minimum amount of product necessary to 
cover the skin or wound area and wash gently 
• 
Rinse again thoroughly  
Inactive ingredients 
Cocamide DEA, fragrance, glucono-delta-lactone, 
hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-
75 lanolin, purified water, tridecyl alcohol 
Product Display Label 
4% chlorhexidine gluconate 
 
7.5% Povidone Iodine: equal to 0.75% available iodine) 
 
Purpose 
Antiseptic 
Uses 
• 
Disinfectant hand wash and skin cleanser 
• 
Significantly reduces bacteria on the skin 

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12 
Warnings 
For external use only 
Do not use this product 
• 
In the eyes 
• 
Over large areas of the body 
• 
If you are allergic to povidone-iodine or any other 
ingredients in this preparation 
• 
Longer than 1 week unless directed by a doctor 
Ask a doctor before use if you have 
• 
Deep or puncture wounds 
• 
Serious burns 
• 
Animal bites 
Stop using this product and ask a doctor if 
• 
Redness, irritation, swelling, or pain continues or 
increases 
• 
Infection occurs 
• 
Do not use in contact with meninges, or over skin of head 
or face.  
• 
Stop use if irritation, sensitization, or allergic reaction 
occurs. 
• 
Keep out of eyes, ears, and mouth. May cause serious and 
permanent eye injury if placed or kept in the eye during 
surgical procedures or may cause deafness when instilled 
in the middle ear through perforated eardrums. 
• 
If solution should contact these areas, rinse out promptly 
and thoroughly with water 
• 
Wounds which involve more than the superficial layers of 
the skin should not be routinely treated 
• 
Repeated general skin cleansing of large body areas 
should not be done except when the underlying condition 
makes it necessary to reduce the bacterial population of 
the skin. 
 
Directions 
• 
Wet skin and apply a sufficient amount for lather to 
cover all surfaces 
• 
Wash vigorously for at least 15 seconds 
• 
Rinse and dry thoroughly 
How supplied 
Other information store at 25˚C (77˚F); excursions permitted 
between 15˚-30˚C (59˚-86˚F) 
Inactive ingredients 
Ammonium nonoxynol-4 sulfate, nonoxynol-9, purified water, 
sodium hydroxide 
Product Display Label 
Betadine Skin Cleanser 
 
 
 

IRB #:  STU00204759 
 
 
13 
 
 
 
 
 
 
 
 

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14 
Appendix 1: Pre-operative survey 
 
Date ___/___/_____  
 
Surgeon _____________                 Participant ID ________________ 
 
Pre-operative Survey 
 
Welcome to Northwestern Prentice Women’s Hospital. Thank you for participating in a 
survey being conducted by Dr. Magdy Milad on the tolerance of chlorhexidine gluconate or 
povidone iodine vaginal cleansing solutions. Below are questions asking about any vaginal 
symptoms. 
 
Please think back over the past 7 days… 
 
1. VAGINAL DRYNESS 
What was the SEVERITY of your VAGINAL DRYNESS at its WORST? 
Ο None 
Ο Mild 
Ο Moderate 
Ο Severe 
Ο Very severe 
 
2. VAGINAL BURNING 
What was the SEVERITY of your VAGINAL BURNING at its WORST? 
Ο None 
Ο Mild 
Ο Moderate 
Ο Severe 
Ο Very severe 
 
3. VAGINAL ITCHINESS 
What was the SEVERITY of your VAGINAL ITCHINESS at its WORST? 
Ο None 
Ο Mild 
Ο Moderate 
Ο Severe 
Ο Very severe 
 
4. UNUSUAL VAGINAL DISCHARGE 
Did you have any UNUSUAL VAGINAL DISCHARGE? 
Ο Not at all 
Ο A little bit 
Ο Somewhat 
Ο Quite a bit 
Ο Very much 
 
5. PAIN OR BURNING WITH URINATION 
What was the SEVERITY of your PAIN OR BURNING WITH URINATION at its WORST? 
Ο None 
Ο Mild 
Ο Moderate 
Ο Severe 
Ο Very severe 
 
6.   OTHER SYMPTOMS 
Do you have any other symptoms that you wish to report? 
Ο Yes 
Ο No 
Please list any other symptoms: 
1. 
What was the severity of this symptom at its 
WORST? 
O  None  O Mild  O Moderate  O Severe  O Very 
Severe 

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15 
2. 
What was the severity of this symptom at its 
WORST? 
O  None  O Mild  O Moderate  O Severe  O Very 
Severe 
 
 
 

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Appendix 2: Post-operative survey 
 
Date ___/___/_____  
 
Surgeon _____________                 Participant ID ________________ 
 
Post-operative Survey 
 
Thank you for participating in a survey being conducted by Dr. Magdy Milad on the 
tolerance of chlorhexidine gluconate or povidone iodine vaginal cleansing solutions. Below 
are questions asking about any vaginal symptoms.  
 
Please think back from immediately after your surgery to now…. 
 
1. VAGINAL DRYNESS 
What was the SEVERITY of your VAGINAL DRYNESS at its WORST? 
Ο None 
Ο Mild 
Ο Moderate 
Ο Severe 
Ο Very severe 
 
2. VAGINAL BURNING 
What was the SEVERITY of your VAGINAL BURNING at its WORST? 
Ο None 
Ο Mild 
Ο Moderate 
Ο Severe 
Ο Very severe 
 
3. VAGINAL ITCHINESS 
What was the SEVERITY of your VAGINAL ITCHINESS at its WORST? 
Ο None 
Ο Mild 
Ο Moderate 
Ο Severe 
Ο Very severe 
 
4. UNUSUAL VAGINAL DISCHARGE 
Did you have any UNUSUAL VAGINAL DISCHARGE? 
Ο Not at all 
Ο A little bit 
Ο Somewhat 
Ο Quite a bit 
Ο Very much 
 
5. PAIN OR BURNING WITH URINATION 
What was the SEVERITY of your PAIN OR BURNING WITH URINATION at its WORST? 
Ο None 
Ο Mild 
Ο Moderate 
Ο Severe 
Ο Very severe 
 
6.   OTHER SYMPTOMS 
Do you have any other symptoms that you wish to report? 
Ο Yes 
Ο No 
Please list any other symptoms: 
1. 
What was the severity of this symptom at its 
WORST? 
O  None  O Mild  O Moderate  O Severe  O Very 
Severe 

IRB #:  STU00204759 
 
 
17 
2. 
What was the severity of this symptom at its 
WORST? 
O  None  O Mild  O Moderate  O Severe  O Very 
Severe 
 
 
 
 
                                                        
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iodine for surgical-site antisepsis. N Engl J Medicine 2010;362:18–26. 
2 Vorherr H, Vorherr UF, Mehta P, Ulrich JA, Messer RH. Vaginal absorption of povidone-iodine. JAMA 1980;244:2628–9. 
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