Vaginal Preparation Prior to Hysterectomy



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:10/27/2018
Start Date:May 18, 2018
End Date:July 2019
Contact:Eunsun Yook, MS
Email:eunsun_yook@trihealth.com
Phone:513-463-4300

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Is Chlorhexidine Vaginal Preparation Prior to Hysterectomy Superior to Iodine in Reducing Bacterial Count; a Randomized Controlled Trial

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.

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.

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
We found this trial at
1
site
Cincinnati, Ohio 45220
Principal Investigator: Catrina C Crisp, MD
?
mi
from
Cincinnati, OH
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