Vaginal Preparation Prior to Hysterectomy

• Status: Terminated
• Trial end date: 2020-01-29
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TriHealth Inc.
• Treatments: Cadexomer iodine; Chlorhexidine; Chlorhexidine gluconate; Iodine

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