Vaginal Preparation Prior to Hysterectomy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-18

Study Completion Date

2020-01-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Chlorhexidine vs. Iodine for Vaginal Preparation in Urogynecologic Procedures

NCT04048356

Pelvic Organ Prolapse Urinary Incontinence Pelvic Floor Disorders +4 more

COMPLETED PHASE3

Efficacy of Two Vaginal Solutions in Preoperative Use

NCT03014778

Vaginal Surgeries

UNKNOWN PHASE4

Vaginal Preparation With Chlorhexidine-alcohol vs. Povidine-iodine vs. Saline

NCT03640507

Cesarean Section; Infection Surgical Site Infection

COMPLETED PHASE2/PHASE3

Vaginal Cleansing With Chlorhexidine Versus Iodine for Prevention of Endometritis

NCT06936475

Endometritis Vaginal Cleansing Post Caesarean

COMPLETED NA

Vaginal Prep Solutions to Reduce Bacteria Colony Counts in Patients Having a Vaginal Surgery

NCT03854370

Surgical Site Infection Vaginal Surgery

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hysterectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Chlorhexidine group

Group Type EXPERIMENTAL

Chlorhexidine

Intervention Type DRUG

Chlorhexidine preparation solutions

Iodine group

Group Type ACTIVE_COMPARATOR

Iodine

Intervention Type DRUG

Iodine-based preparation solutions

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Chlorhexidine

Chlorhexidine preparation solutions

Intervention Type DRUG

Iodine

Iodine-based preparation solutions

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No