Vaginal Preparation Prior to Hysterectomy

Is Chlorhexidine Vaginal Preparation Prior to Hysterectomy Superior to Iodine in Reducing Bacterial Count; a Randomized Controlled Trial

This is a randomized controlled trial to determine the influence of chlorhexidine gluconate surgical/topical antiseptic solutions on the bacterial environment of the vagina during hysterectomy and compare that to the effect of standard iodine-based preparations on the same.

Study Overview

• Status: Terminated
• Conditions: Hysterectomy
• Intervention / Treatment: Drug: Chlorhexidine; Drug: Iodine

Detailed Description

Postoperative infection remains the most common complication of surgical procedures in gynecology. Historically, 30-40% of patients undergoing a hysterectomy develop a post-operative infection. The initiation of antibiotic prophylaxis for appropriate surgical procedures was a significant advancement in the prevention of surgical site infection.

Antibiotic prophylaxis has been standardized and universally implemented. A remaining variable is the method of aseptic preparation of the vagina with substantial variation of technique being reported even within institutions.

The most recent Committee Opinion by the American College of Obstetricians and Gynecologists concludes there is insufficient evidence to render a strong recommendation for either povidone-iodine or chlorhexidine as the ideal agent for surgical preparation of the vagina and that further evidence is necessary.

Povidone-iodine solution has been considered the standard for aseptic surgical preparation of the vagina for decades and is the only solution approved by the FDA for vaginal use. There are however specific qualities of the solution that suggest it may be less than ideal for use in the vagina. More contemporary efforts have begun to focus on chlorhexidine as a more ideal agent for aseptic efforts in surgical preparation of the vagina.

The purpose of our study is to use a randomized controlled trial to determine if chlorhexidine gluconate surgical preparation maintains a lower rate of contamination to the surgical field.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Undergoing total vaginal, laparoscopic assisted vaginal, total laparoscopic, or robotic-assisted laparoscopic hysterectomy by a physician at Cincinnati Urogynecology Associates or Tri-State Gynecology Oncology TriHealth Inc.
• Concomitant procedures such as vaginal vault suspension, suburethral sling, cystoscopy, enterocele repair, anterior or posterior colporrhaphy, bilateral salpingectomy or salpingooophorectomy, staging procedures, lymph node sampling and other indicated procedures will be included
• English speaking
• Ability to provide consent

Exclusion Criteria:

• Unwillingness to participate in the study
• Non English speaking
• Patients that do not undergo a hysterectomy
• Reported allergy to iodine or chlorhexidine preparation solutions
• Patients undergoing planned debulking surgery for ovarian, fallopian tube or primary peritoneal cancers
• Current infection necessitating hysterectomy
• Active sepsis, pelvic abscess or pelvic inflammatory disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chlorhexidine group	Drug: Chlorhexidine; Chlorhexidine preparation solutions
Active Comparator: Iodine group	Drug: Iodine; Iodine-based preparation solutions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Contamination	Contamination is defined as having >5000 bacteria within a culture	90 minutes from initial preparation

Collaborators and Investigators

• Sponsor: TriHealth Inc.
• Investigators: Principal Investigator: Catrina Crisp, MD, TriHealth - Cincinnati Urogynecology Associates

Publications and helpful links

General Publications

• Nugent RP, Krohn MA, Hillier SL. Reliability of diagnosing bacterial vaginosis is improved by a standardized method of gram stain interpretation. J Clin Microbiol. 1991 Feb;29(2):297-301. doi: 10.1128/jcm.29.2.297-301.1991.
• Hill AM, Pauls RN, Basil J, Tam T, Yook E, Shatkin-Margolis A, Kleeman S, Yeung J, Aldrich E, Crisp CC. Chlorhexidine Versus Iodine for Vaginal Preparation Before Hysterectomy: A Randomized Clinical Trial. Female Pelvic Med Reconstr Surg. 2022 Feb 1;28(2):77-84. doi: 10.1097/SPV.0000000000001066.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2018
• Primary Completion (Actual): August 26, 2019
• Study Completion (Actual): January 29, 2020

Study Registration Dates

• First Submitted: January 22, 2018
• First Submitted That Met QC Criteria: January 22, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): January 11, 2021
• Last Update Submitted That Met QC Criteria: January 6, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants; Chlorhexidine
• Other Study ID Numbers: 17-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No