Clinical trial NCT03412734: Vaginal Preparation Prior to Hysterectomy
Official title: Is Chlorhexidine Vaginal Preparation Prior to Hysterectomy Superior to Iodine in Reducing Bacterial Count; a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hysterectomy
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 94
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Contamination
timeFrame: 90 minutes from initial preparation
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
Study officials:
affiliation: TriHealth - Cincinnati Urogynecology Associates
name: Catrina Crisp, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.