Vaginal Preparation Prior to Hysterectomy

NCT03412734 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 17-102
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Hysterectomy

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Contamination

  Contamination is defined as having \>5000 bacteria within a culture

  90 minutes from initial preparation

Study Arms (2)

Chlorhexidine group

EXPERIMENTAL

Drug: Chlorhexidine

Iodine group

ACTIVE COMPARATOR

Drug: Iodine

Interventions

Chlorhexidine DRUG

Chlorhexidine preparation solutions

Chlorhexidine group

Iodine DRUG

Iodine-based preparation solutions

Iodine group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

Good Samaritan Hospital

Cincinnati, Ohio, 45220, United States

Location

Related Publications (2)

• 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.

  PMID: 1706728 RESULT

• 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.

  PMID: 34333502 DERIVED

MeSH Terms

Interventions

Chlorhexidine; Iodine

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Halogens; Elements; Inorganic Chemicals

Results Point of Contact

• Title: Catrina Crisp, MD MSc
• Organization: TriHealth Inc.

Catrina_Crisp@trihealth.com

513-463-4300

Study Officials

• Catrina Crisp, MD

  TriHealth - Cincinnati Urogynecology Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: January 26, 2018
• Study Start: May 18, 2018
• Primary Completion: August 26, 2019
• Study Completion: January 29, 2020
• Last Updated: January 11, 2021
• Results First Posted: November 18, 2020

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)