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Chlorhexidine Gluconate Versus Povidone-iodine

NCT ID: NCT04658355

Last Updated: 2020-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-15

Study Completion Date

2022-05-31

Brief Summary

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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

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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

Conditions

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Vaginal Flora Imbalance

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Chlorhexidine Gluconate vs Povidone-iodine group
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Povidone-Iodine

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

Group Type ACTIVE_COMPARATOR

Povidone-iodine

Intervention Type OTHER

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

Chlorhexidine Gluconate

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

Group Type EXPERIMENTAL

Chlorhexidine Gluconate

Intervention Type OTHER

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

Interventions

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Chlorhexidine Gluconate

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

Intervention Type OTHER

Povidone-iodine

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Gabriella Smith

Resident Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mike Foley, MD

Role: STUDY_CHAIR

Banner University Medical Center - Phoenix/ University of Arizona

Central Contacts

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Elisa Martinez, MBA

Role: CONTACT

Phone: 480-430-4810

Email: [email protected]

Regina Montero, MSN

Role: CONTACT

Phone: 480-239-8697

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 27234011 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7463676 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 23963423 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21942546 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15695981 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 9403248 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17980335 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 20042564 (View on PubMed)

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

Reference Type 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.

Reference Type 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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 6736662 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31539059 (View on PubMed)

Other Identifiers

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2008991024

Identifier Type: -

Identifier Source: org_study_id