A Randomized Trial of Vaginal Prep Solutions to Reduce Bacteria Colony Counts in Patients Having a Vaginal Surgery
Phase: NA
Conditions: Surgical Site Infection, Vaginal Surgery
Sponsor: Wright State University

Version: 6 
Date: 01/18/2023 
TITLE  
A randomized trial of vaginal prep solutions to reduce bacteria colony counts in patients having a 
vaginal surgery. 
INVESTIGATORS  
Geoffrey Towers, MD, Rose Maxwell, PhD, James Saelens, MD 
SUMMARY OR ABSTRACT   
This is a randomized trial comparing the effectiveness of 4 vaginal prep solutions 
(betadine, baby shampoo, TechniCare and Peridex) on reducing bacterial colony counts during 
surgery preparation. Women undergoing a vaginal surgery will be enrolled into the trial prior to 
surgery. Target sample size per group is 15 patients. During standard surgical prep, a vaginal 
swab will be taken to assess the initial colony counts for aerobic and anaerobic bacteria. After 
the initial swab, the vagina will be prepared using one of the prep 4 solutions (betadine, baby 
shampoo, TechniCare or Peridex). After a predefined 10 minutes, the area will be re-swabbed to 
determine pre-procedure colony counts. A third  swab will be taken following completion of the 
procedure to determine post-procedure colony counts. Laboratory analyses for raw colony 
counts, sensitivities, identification (using MALDI-TOF) will be performed. We expect that there 
will be reduced colony counts at the pre-procedure point with baby shampoo having the least 
reduction, followed by betadine and TechniCare, then Peridex. Patient reported outcomes for 
vaginal itching and burning as well as patient report of any treatment for vaginal infection will be 
collected by telephone at 2 days, 2 weeks and 1 month post-surgery. 
BACKGROUND AND LITERATURE REVIEW  
 Antiseptic preparation for surgical incision sites has greatly reduced postoperative infections. 
However, surgical site infections (SSI) are still the leading cause of hospitalizations after 

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Date: 01/18/2023 
surgery. With the application of antiseptic preparation, a reduction in bacterial counts follows. 
The rate at which the bacterial counts rise between preparation and incision may be of variation 
depending on the surgical antiseptic scrub.    
 Betadine (Povidone- iodine), Peridex (Chlorhexidine), baby shampoo and TechniCare 
(chloroxynel) are all surgical scrubs approved for the preparation of vaginal access surgeries. 
While there has been controversy on the use of Chlorohexidine for vaginal preparation surgery, 
due to its labeling as a cause for irritation, studies have shown that when 2-4% Chlorhexidine is 
used in the vaginal area there are little to no signs of irritation and the bacteria counts post 
incision are less than the bacterial counts for povidone iodine1,2. Baby shampoo can also be used 
as an effective antiseptic scrub with no irritation and no statistical difference in bacterial count 
reduction as compared to povidone-iodine3. Little research has been done to look at the antiseptic 
power of Chloroxylenol in vaginal surgeries. However, when used as a root canal antiseptic it 
can reduce bacteria counts by 99.9%4. This is illustrative of its capability to reduce bacteria on a 
mucus membrane similar to the vagina.  
 There is literature that shows the antiseptic power of Betadine, Peridex, Baby shampoo and 
TechniCare for post-incisional bacteria counts, but little is known about the pre-incisional power 
of these scrubs for vaginal access surgeries. 
SPECIFIC AIMS OR OBJECTIVES 
The aim of this study is to understand the power of vaginal surgical scrubs before and 
after procedure completion. This will be done by collecting bacterial samples before antiseptic 
preparation, 10 minutes after antiseptic preparation, and after completion of the procedure along 
with follow-up data of irritation, infection post-surgery, and infection risk factors of each patient. 
SIGNIFICANCE TO PATIENT, INSTITUTION, PROFESSION, OR ALL  

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Date: 01/18/2023 
 Vaginal preparation research provides beneficial knowledge to hospitals and physicians in the 
prevention of surgical site infections (SSI). This specific project will provide insight regarding 
the bacteria-eliminating power of four different surgical scrubs used on the vaginal mucous 
membrane. There is potential for this study to determine the most effective scrub for vaginal 
surgeries, as well as correlate pre-procedure bacterial counts and likelihood of surgical site 
infections. The information collected from this study could benefit future patients and hospitals 
alike in terms of reducing the risk of SSI’s. The risks of this study could be unidentified allergies 
to any of the surgical scrubs, or a loss of patient data. These are unlikely risks due to the protocol 
of the study.  
METHODS  
This study will use block randomization. There will be four arms of the study one for 
each of the four surgical scrubs. There will be approximately 15 patients per arm.  Patients 
undergoing surgeries which require a vaginal antiseptic preparation will be recruited from 
Wright State Physicians Obstetrics and Gynecology as well as other participating groups at 
Miami Valley Hospital. Procedures included in the study are procedures in which a vaginal 
preparation is performed, including procedures with a vaginal incision (hysterectomy, 
incontinence procedures), as well as general laparoscopic procedures (diagnostic laparoscopy, 
salpingectomy, oophorectomy, etc). Procedures excluded from the study are procedures which 
involve: any local infectious process such as cellulitis or abscess, have significant risk of 
washout of the vaginal preparation (hysteroscopy or vaginoscopy), any procedures for invasive 
cancer diagnoses, or procedures with significant risk of bleeding such as dilation and curettage 
(both for sampling or pregnancy-related), or endometrial ablation. Revision surgeries will also be 
excluded to decrease any complications. Patients who consent to the study will be given a ID and 

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Date: 01/18/2023 
will be randomly assigned to one of the four arms. Patients will be excluded if an allergy to any 
of the scrubs is listed or found. Each recruited patient will be over the age of 18 with ability to 
consent on their own. 
Each patient will be given a standard prophylaxis 30 minutes before surgery. After 
prophylaxis administration and before surgical antiseptic preparation, a 10 second swab will be 
taken of the vagina making sure to span the surface area of the vaginal canal with avoidance of 
the cervix. The swab will then be broken off into a tube labeled with the patient ID, date, and 
“pre-scrub.” The patient will then undergo antiseptic preparation with the assigned surgical prep. 
A standard procedure of application will be done for each of the arms. Ten minutes after 
application, another swab will be taken using the same procedure as the “pre-scrub” swab. This 
swab will be broken off in a tube labeled with the patient ID, date, and “post-scrub.”1 Following 
the conclusion of the procedure, a third swab will be taken using the same procedure as the two 
pre-incision swabs. The third swab will then be broken off into a tube labeled with the patient 
ID, date, and “post-procedure-swab.” The swabs will then be transported to CompuNet where 
they will be analyzed for aerobic, anaerobic bacteria and fungal colonies using Matrix Assisted 
Depolarization/Ionization Time of Flight mass spectrometry (MALDI-TOF).  
The data of colony counts will be collected from CompuNet. BMI, age, prophylaxis, 
postmenopausal information, diabetic information, smoking history, surgical duration, 
complication in surgery, and length of hospital stay will all be collected from patient records. No 
patient identifiers will be collected5. Patients will be followed up on their surgery approximately 
two days, two weeks and a month after surgery to get information on irritation and/or surgical 
infection. This data will be collected either be phone call or at post-surgical follow-up 
appointment at Wright State Physicians. The South Hampton Grading Scheme for Surgical 

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Wounds will be used to Quantify Each patients level of irritation and/or infection. The scale is a 
Zero to Five score, with Zero being no irritation or infection and Five being severe irritation or 
infection15.  
One potential obstacle of this study could be recruitment of patients. Patients will not be 
given incentive for participation and will not acquire any direct benefit from the study. Another 
potential issue may arise from the size of the study; there may not be enough subjects recruited 
for each arm of the study to find a detectable and significant difference in the use of one surgical 
scrub over another. There may also not be sufficient power to detect a difference in the risk of 
post-operative surgical site infections.  
Precautions will need to be taken for allergies. A recruited patient may not be aware of 
personal allergies to the surgical scrubs. This would put the patient in harm if they are assigned 
to a scrub that they are allergic to. Since data will be collected from the patient’s medical 
records, precautions will be taken to avoid loss of patient identifiers. All research investigators 
will only utilize the patients assigned research ID. This will both protect the patient and avoid 
bias.  
Statistical Analysis Plan 
Bacterial and fungal colony counts will be coded as positive if counts are ≥5000 colonies/mL 
and negative if < 5000 colonies. Statistical analyses will be conducted as follows: 
Baseline charasteristics will be compared with Chi square (categorical data) and ANOVA 
(continuous data) to determine potential differences for demographic and clinical characteristics 
and for colony counts (positive vs negative) at the pre-scrub sample collection.  
Each of the 3 target scrubs (baby shampoo, chlorhexidine and chloroxynel ) will be compared to 
povidone-iodine as the standard of care using Fisher’s Exact tests for each pair comparison at the 

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post-scrub and post-procedure collections. 
 
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