Efficacy of Two Vaginal Solutions in Preoperative Use

HaEmek Medical Center, Israel70 enrolled

Overview

This study is necessary in order to provide proof the effectiveness of Chlorhexidine gluconate and its safety.

It is well known from the literature that the use of Povidone-iodone based solution for vaginal preparation before surgery is fraught with side effects and sensitivity, and often does not provide sufficient eradication of colonies of pathogens from the operation field. It is also known that Chlorhexidine gluconate in low concentration provides a better result and does not cause side effects more than Povidone-iodone, but the chlorhexidine is still not approved for washing the mucous membranes. This study is necessary in order to provide proof of its effectiveness and safety.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Vaginal Surgeries

Interventions

The Chlorhexidine gluconate 0.05%DRUG

Washing vagina pre- operatively with Chlorhexidine gluconate 0.05%

10% Povidone iodineDRUG

Washing vagina pre- operatively with 10% Povidone iodine

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients over the age of 18 2. Candidates for surgery (TOT- Trans Obturator Tape, cystoscopy, the introduction / removal of the stent the ureter, ureteroscopy), local or general anesthesia. Exclusion Criteria: 1. A pregnant woman or post-partum. 2. A woman with known sensitivity to iodine, povidon or chlorhexidine. 3. Previous pelvic surgeries within three months from the surgery planned. 4. Patients taking antibiotics within one month from the surgery planned. 5. Immunological failure patients. 6. Patient unwilling to participate in the study. 7. Patients who require the appointment of a guardian condition 8. Women assigned to undergo a regular cystoscopy (no further action).

Locations (1)

Haemek Medical Center

Afula, Afula, Israel

RECRUITING

Outcomes

Primary Outcomes

Changing in the number of colonies that grew at every stage

Time frame: Before the washing, 10 minutes after washing, 30 minutes after washing.

Secondary Outcomes

Signs of local irritation mucosa after each bathing preparations by looking at the mucosa, at the end of the clinical assessment.

Time frame: 30 minutes after washing.

The appearance of signs of systemic allergic reactions after each bathing by looking at the mucosa, at the end of the clinical assessment.

Time frame: Before the washing, 10 minutes after washing, 30 minutes after washing.

Central Contacts

Sharon Tzemah, MD

CONTACT

97252-6678244 sharon_tze1@clalit.org.il

Michael Gross, MD

CONTACT

97254-6676778 michael_gr1@clalit.org.il

Data from ClinicalTrials.gov

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