Chlorhexidine Gluconate Versus Povidone-iodine

NCT04658355 | Unknown

• 1 other identifier: 2008991024
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vaginal Flora Imbalance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Relative abundances of vaginal microbiota species

  From date of surgery to 3-6 weeks postoperative

Other Outcomes (2)

• Change in level of genital cytokines and chemokines

  From date of surgery to 3-6 weeks post-operative

• Change in vaginal pH level

  From date of surgery to 3-6weeks post-operative

Study Arms (2)

Povidone-Iodine

ACTIVE COMPARATOR

Povidone-iodine to be used as the cleansing solution in this arm of patients for surgical vaginal preparation.

Other: Povidone-iodine

Chlorhexidine Gluconate

EXPERIMENTAL

Chlorhexidine gluconate to be used as the cleansing solution in this arm of patients for surgical vaginal preparation.

Other: Chlorhexidine Gluconate

Interventions

Chlorhexidine Gluconate OTHER

4% Chlorhexidine Gluconate vaginal cleansing solution as a surgical preparation.

Chlorhexidine Gluconate

Povidone-iodine OTHER

10% povidone-iodine vaginal cleansing solution as a surgical preparation.

Povidone-Iodine

Eligibility Criteria

• Age: 18 Years - 89 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females
• all races and ethnicities
• English-speaking
• pre-menoupausal
• undergoing gynecologic surgeries requiring vaginal operative preparation at Banner University Medical Center - Phoenix.

You may not qualify if:

• Patients with dx of vaginitis or vulvovaginal atrophy at time of surgery
• Patients with an allergy to povidone-iodine and/or Chlorhexidine Gluconate
• 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
• Currently menstruating
• 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
• Have a history of or current, self-reported genital herpes
• Have current or in the past 6 weeks, conditions such as
• Vaginal infection/bacterial vaginosis/yeast infection or sexually transmitted infection (Chlamydia, Gonorrhea or Trichomonas)/Hepatitis/HIV
• Vulvar infection
• Urinary tract infection
• Sexual intercourse less than 48 hours prior to the visit
• Current treatment for any skin conditions on the testing area

Sponsors & Collaborators

• University of Arizona: lead

Related 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.

  PMID: 27234011 BACKGROUND

• 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.

  PMID: 7463676 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 23963423 BACKGROUND

• 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. doi: 10.1177/026119291103900403.

  PMID: 21942546 BACKGROUND

• 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.

  PMID: 15695981 BACKGROUND

• Fleischer W, Reimer K. Povidone-iodine in antisepsis--state of the art. Dermatology. 1997;195 Suppl 2:3-9. doi: 10.1159/000246022.

  PMID: 9403248 BACKGROUND

• 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.

  PMID: 17980335 BACKGROUND

• Mac Bride MB, Rhodes DJ, Shuster LT. Vulvovaginal atrophy. Mayo Clin Proc. 2010 Jan;85(1):87-94. doi: 10.4065/mcp.2009.0413.

  PMID: 20042564 BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 6736662 BACKGROUND

• 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.

  PMID: 31539059 BACKGROUND

MeSH Terms

Interventions

chlorhexidine gluconate; Povidone-Iodine

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Mike Foley, MD

  Banner University Medical Center - Phoenix/ University of Arizona

  STUDY CHAIR

Central Study Contacts

Elisa Martinez, MBA

CONTACT

480-430-4810; elisamartinez@arizona.edu

Regina Montero, MSN

CONTACT

480-239-8697; rmontero52@arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Model Details: Chlorhexidine Gluconate vs Povidone-iodine group

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: December 8, 2020
• Study Start: December 15, 2020
• Primary Completion: August 1, 2021
• Study Completion: May 1, 2022
• Last Updated: December 8, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share