Efficacy of Two Vaginal Solutions in Preoperative Use

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

Detailed Description
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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.

Official Title
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Efficacy Comparison of Two Vaginal Solutions for Preoperative Use in Candidate Women for Vaginal Surgeries

Conditions
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Vaginal Surgeries

Intervention / Treatment
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* Drug: The Chlorhexidine gluconate 0.05%
* Drug: 10% Povidone iodine


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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Chlorhexidine gluconate arm<br>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. | Drug: The Chlorhexidine gluconate 0.05%<br>* Washing vagina pre- operatively with Chlorhexidine gluconate 0.05%<br>* Other names: Sterets unisept;|
| Active Comparator: The Povidone iodine arm<br>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. | Drug: 10% Povidone iodine<br>* Washing vagina pre- operatively with 10% Povidone iodine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |