Efficacy of Two Vaginal Solutions in Preoperative Use

Phase 4

• Conditions: Vaginal Surgeries
• Interventions: Drug: 10% Povidone iodine; Drug: The Chlorhexidine gluconate 0.05%

• Registration Number: NCT03014778
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-01-06
• Study First Posted: 2017-01-09
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-26
• Last Update Posted: 2018-02-28
• Primary Completion: 2018-12-31
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 70

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The Povidone iodine arm	10% Povidone iodine	35 women undergoing surgery will be vaginally pre-op washed by 10% Povidone iodine, 50 cc for 1 minute. 3 samples will be taken for culture: before, 10 minutes and 30 minutes after the wash.
The Chlorhexidine gluconate arm	The Chlorhexidine gluconate 0.05%	35 women undergoing surgery will be vaginally pre-op washed by 0.05% chlorhexidine gluconate, 50 cc for 1 minute. 3 samples will be taken for culture: before, 10 minutes and 30 minutes after the wash.

Primary Outcome Measures

Name	Time	Method
Changing in the number of colonies that grew at every stage	Before the washing, 10 minutes after washing, 30 minutes after washing.

Secondary Outcome Measures

Name	Time	Method
Signs of local irritation mucosa after each bathing preparations by looking at the mucosa, at the end of the clinical assessment.	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.	Before the washing, 10 minutes after washing, 30 minutes after washing.

Trial Locations

Locations (1)

Haemek Medical Center; 🇮🇱 'Afula, Afula, Israel