Chlorhexidine Gluconate Versus Povidone-iodine

Vaginal Flora Imbalance Clinical Trial

— CHDvPI  

Official title:

Effect of Chlorhexidine Gluconate Versus Povidone-iodine on the Vaginal Microbiome as Vaginal Operative Preparation During Gynecologic Surgeries

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04658355
• Other study ID #: 2008991024
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: May 2022

Study information

• Verified date: December 2020
• Source: University of Arizona
• Contact: Elisa Martinez, MBA
• Phone: 480-430-4810
• Email: elisamartinez[@]arizona.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 2022
• Est. primary completion date: August 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 89 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Vaginal Flora Imbalance

Intervention

Other:
• Chlorhexidine Gluconate
4% Chlorhexidine Gluconate vaginal cleansing solution as a surgical preparation.
• Povidone-iodine
10% povidone-iodine vaginal cleansing solution as a surgical preparation.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

References & Publications (14)

Al-Niaimi A, Rice LW, Shitanshu U, Garvens B, Fitzgerald M, Zerbel S, Safdar N. Safety and tolerability of chlorhexidine gluconate (2%) as a vaginal operative preparation in patients undergoing gynecologic surgery. Am J Infect Control. 2016 Sep 1;44(9):996-8. doi: 10.1016/j.ajic.2016.02.036. Epub 2016 May 24. — View Citation

American College of Obstetricians and Gynecologists Women's Health Care Physicians; Committee on Gynecologic Practice. Committee Opinion No. 571: Solutions for surgical preparation of the vagina. Obstet Gynecol. 2013 Sep;122(3):718-20. doi: 10.1097/01.AOG.0000433982.36184.95. — View Citation

Amstey MS, Jones AP. Preparation of the vagina for surgery. A comparison of povidone-iodine and saline solution. JAMA. 1981 Feb 27;245(8):839-41. — View Citation

Aronson JK. Antiseptic drugs and disinfectants. In: Side effects of drugs annual. Vol 35. Elsevier Science & Technology; 2014:435-445. https://www.sciencedirect.com/science/article/pii/B9780444626356.000243. 10.1016/B978-0-444-62635-6.00024-3.

Costin GE, Raabe HA, Priston R, Evans E, Curren RD. Vaginal irritation models: the current status of available alternative and in vitro tests. Altern Lab Anim. 2011 Sep;39(4):317-37. Review. — View Citation

Culligan PJ, Kubik K, Murphy M, Blackwell L, Snyder J. A randomized trial that compared povidone iodine and chlorhexidine as antiseptics for vaginal hysterectomy. Am J Obstet Gynecol. 2005 Feb;192(2):422-5. — View Citation

Fleischer W, Reimer K. Povidone-iodine in antisepsis--state of the art. Dermatology. 1997;195 Suppl 2:3-9. Review. — View Citation

Lewis LA, Lathi RB, Crochet P, Nezhat C. Preoperative vaginal preparation with baby shampoo compared with povidone-iodine before gynecologic procedures. J Minim Invasive Gynecol. 2007 Nov-Dec;14(6):736-9. — View Citation

Mac Bride, Maire B., MBBCh, Rhodes DJ, MD, Shuster LT, MD. Vulvovaginal atrophy. Mayo Clinic Proceedings. 2010;85(1):87-94. https://www.clinicalkey.es/playcontent/1-s2.0-S0025619611603145. doi: 10.4065/mcp.2009.0413.

Mahoney JB, Chernesky MA. Institutional infection control and prevention. Manual of clinical microbiology. 1999:108-190.

Rastogi S, Glaser L, Friedman J, Carter IV, Milad MP. Tolerance of chlorhexidine gluconate vaginal cleansing solution: A randomized controlled trial. Journal of Gynecologic Surgery. 2019. doi: 10.1089/gyn.2019.0066.

US National Library of Medicine.4% chlorhexidine gluconate skin cleansing kit; US food and drug administration (FDA) approved product information. DailyMed Web site. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=65f87900-8d23-4fb3-be44-1d116aedac78. Updated 2015.

Vorherr H, Vorherr UF, Mehta P, Ulrich JA, Messer RH. Antimicrobial effect of chlorhexidine and povidone-iodine on vaginal bacteria. J Infect. 1984 May;8(3):195-9. — View Citation

Wilkinson EM, Laniewski P, Herbst-Kralovetz MM, Brotman RM. Personal and Clinical Vaginal Lubricants: Impact on Local Vaginal Microenvironment and Implications for Epithelial Cell Host Response and Barrier Function. J Infect Dis. 2019 Nov 6;220(12):2009-2018. doi: 10.1093/infdis/jiz412. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in level of genital cytokines and chemokines	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	From date of surgery to 3-6 weeks post-operative
Other	Change in vaginal pH level	To measure the change vaginal pH after treatment with chlorhexidine gluconate or a povidone-iodine vaginal cleansing solution.	From date of surgery to 3-6weeks post-operative
Primary	Frequency of patient-reported vaginal and urinary symptoms after treatment with chlorhexidine gluconate or povidone-iodine vaginal cleansing solution	To compare the frequency of patient-reported vaginal and urinary symptoms after treatment with chlorhexidine gluconate or povidone-iodine vaginal cleansing solution utilizing questionnaires.	From date of surgery to 24 hours post-operative
Secondary	Relative abundances of vaginal microbiota species	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	From date of surgery to 3-6 weeks postoperative