Vaginal Flora Imbalance
Conditions
Brief summary
A hysterectomy, or removal of the uterus, is a common surgery performed for a variety of reasons. During this surgery, to prevent infection, the vagina is thoroughly prepped with a cleansing solution, most commonly chlorhexidine gluconate or povidone-iodine. While studies have shown that chlorhexidine gluconate is better at killing bacteria people have raised concerns on how it affects the vaginal tissue. It is important to study these effects the cleansing solution surgeons use for this surgery can not only prevent infection but not cause harmful side effects.
Detailed description
The purpose of this study is to examine the effects of different vaginal operative preparations on the vaginal tissue and microbiome. Our primary working hypothesis is that chlorhexidine prep is more deleterious to vaginal tissue than povidone-iodine preparations. Hypothesis 1: chlorhexidine gluconate is more disruptive to the vaginal microbiome than povidone-iodine Hypothesis 2: chlorhexidine gluconate leads to more vaginal atrophy than povidone-iodine
Interventions
OTHERChlorhexidine Gluconate
4% Chlorhexidine Gluconate vaginal cleansing solution as a surgical preparation.
OTHERPovidone-iodine
10% povidone-iodine vaginal cleansing solution as a surgical preparation.
Sponsors
University of Arizona
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Chlorhexidine Gluconate vs Povidone-iodine group
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* Inclusion Criteria: 1. Females 2. all races and ethnicities 3. English-speaking 4. pre-menoupausal 5. undergoing gynecologic surgeries requiring vaginal operative preparation at Banner University Medical Center - Phoenix.
Exclusion criteria
1. Patients with dx of vaginitis or vulvovaginal atrophy at time of surgery 2. Patients with an allergy to povidone-iodine and/or Chlorhexidine Gluconate 3. Individuals with any skin conditions, as determined by the physician, which could interfere with the conduct of the study or increase the risks to the test subject including any open or healing cuts/incisions, abrasions, or broken skin in the testing area as determined by the physician 4. Currently menstruating 5. Be using or have used antibiotics, antifungals, topical steroids or antiviral (oral or topical in the testing areas) less than 12 weeks prior to visit 6. Have a history of or current, self-reported genital herpes 7. Have current or in the past 6 weeks, conditions such as 1. Vaginal infection/bacterial vaginosis/yeast infection or sexually transmitted infection (Chlamydia, Gonorrhea or Trichomonas)/Hepatitis/HIV 2. Vulvar infection 3. Urinary tract infection 8. Sexual intercourse less than 48 hours prior to the visit 9. Current treatment for any skin conditions on the testing area
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of patient-reported vaginal and urinary symptoms after treatment with chlorhexidine gluconate or povidone-iodine vaginal cleansing solution | From date of surgery to 24 hours post-operative | To compare the frequency of patient-reported vaginal and urinary symptoms after treatment with chlorhexidine gluconate or povidone-iodine vaginal cleansing solution utilizing questionnaires. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative abundances of vaginal microbiota species | From date of surgery to 3-6 weeks postoperative | To measure the change in relative abundances of vaginal microbiota species after treatment with chlorhexidine gluconate or a povidone-iodine vaginal cleansing solution. Vaginal microbiota species include but not limited to health-associated Lactobacillus spp., bacterial-vaginosis associated anaerobes (Gardnerella, Prevotella, Sneathia, Atopobium, Megasphaera, Parvimonas, Mobiluncus and others), pathobionts (Streptococcus, Escherichia), and other bacterial taxa present in the collected vaginal swabs using 16S rRNA sequencing |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in level of genital cytokines and chemokines | From date of surgery to 3-6 weeks post-operative | To measure the change in levels of genital cytokines and chemokines (IL-1alpha, IL-1beta, IL-8, MIP-1beta, MIP-3alpha, RANTES, TNFalpha) in the collected cervicovaginal lavages using multiplex cytometric bead arrays after treatment with chlorhexidine gluconate or a povidone-iodine vaginal cleansing solution. The cytokine levels will be used to determine the genital inflammatory score by using a previously described genital inflammation scoring system. Patients will be assigned one point for each mediator when the level was in the upper quartile |
| Change in vaginal pH level | From date of surgery to 3-6weeks post-operative | To measure the change vaginal pH after treatment with chlorhexidine gluconate or a povidone-iodine vaginal cleansing solution. |
Contacts
Primary ContactElisa Martinez, MBA
Backup ContactRegina Montero, MSN
Outcome results
None listed