Clinical trial NCT04658355: Chlorhexidine Gluconate Versus Povidone-iodine
Official title: Effect of Chlorhexidine Gluconate Versus Povidone-iodine on the Vaginal Microbiome as Vaginal Operative Preparation During Gynecologic Surgeries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaginal Flora Imbalance
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2020-12-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Chlorhexidine Gluconate vs Povidone-iodine group
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Frequency of patient-reported vaginal and urinary symptoms after treatment with chlorhexidine gluconate or povidone-iodine vaginal cleansing solution
timeFrame: From date of surgery to 24 hours post-operative
Secondary outcomes:
measure: Relative abundances of vaginal microbiota species
timeFrame: From date of surgery to 3-6 weeks postoperative
Other outcomes:
measure: Change in level of genital cytokines and chemokines
timeFrame: From date of surgery to 3-6 weeks post-operative
measure: Change in vaginal pH level
timeFrame: From date of surgery to 3-6weeks post-operative
Locations:
Study officials:
affiliation: Banner University Medical Center - Phoenix/ University of Arizona
name: Mike Foley, MD
role: STUDY_CHAIR
References:
citation: 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.
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.
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.
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.
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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. doi: 10.1016/j.ajog.2004.08.010.
citation: Fleischer W, Reimer K. Povidone-iodine in antisepsis--state of the art. Dermatology. 1997;195 Suppl 2:3-9. doi: 10.1159/000246022.
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. doi: 10.1016/j.jmig.2007.05.010.
citation: Mac Bride MB, Rhodes DJ, Shuster LT. Vulvovaginal atrophy. Mayo Clin Proc. 2010 Jan;85(1):87-94. doi: 10.4065/mcp.2009.0413.
citation: Mahoney JB, Chernesky MA. Institutional infection control and prevention. Manual of clinical microbiology. 1999:108-190.
citation: 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.
citation: 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.
citation: 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. doi: 10.1016/s0163-4453(84)93811-8.
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.