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Vaginal Preparation Prior to Hysterectomy

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ClinicalTrials.gov Identifier: NCT03412734
Recruitment Status : Terminated (The institutional review board recommended the study stop enrollment prior to achieving its initial sample size for patient safety.)
First Posted : January 26, 2018
Results First Posted : November 18, 2020
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
TriHealth Inc.

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hysterectomy Drug: Chlorhexidine Drug: Iodine Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Is Chlorhexidine Vaginal Preparation Prior to Hysterectomy Superior to Iodine in Reducing Bacterial Count; a Randomized Controlled Trial
Actual Study Start Date : May 18, 2018
Actual Primary Completion Date : August 26, 2019
Actual Study Completion Date : January 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Chlorhexidine group Drug: Chlorhexidine
Chlorhexidine preparation solutions
Active Comparator: Iodine group Drug: Iodine
Iodine-based preparation solutions


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Contamination [ Time Frame: 90 minutes from initial preparation ]
    Contamination is defined as having >5000 bacteria within a culture


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03412734


Locations
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United States, Ohio
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220
Sponsors and Collaborators
TriHealth Inc.
Investigators
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Principal Investigator: Catrina Crisp, MD TriHealth - Cincinnati Urogynecology Associates
  Study Documents (Full-Text)

Documents provided by TriHealth Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] July 20, 2020

More Information
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Publications of Results:

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Responsible Party: TriHealth Inc.
ClinicalTrials.gov Identifier: NCT03412734    
Other Study ID Numbers: 17-102
First Posted: January 26, 2018    Key Record Dates
Results First Posted: November 18, 2020
Last Update Posted: January 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants