Status:
TERMINATED
Vaginal Preparation Prior to Hysterectomy
Lead Sponsor:
TriHealth Inc.
Conditions:
Hysterectomy
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 com...
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 in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 18 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2020
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT03412734
Start Date
May 18 2018
End Date
January 29 2020
Last Update
January 11 2021
Active Locations (1)
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1
Good Samaritan Hospital
Cincinnati, Ohio, United States, 45220