Vaginal Preparation Prior to Hysterectomy

Stopped early · Phase 4

Conditions studied: Hysterectomy

In brief

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.

Key facts

Study ID

NCT03412734

Run by

TriHealth Inc.

People needed

94

Starts

2018-05-18

Expected to finish

2020-01-29

Last updated by the study team

2021-01-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• Good Samaritan Hospital — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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