Efficacy of Two Vaginal Solutions in Preoperative Use

HaEmek Medical Center, Israel

Status and phase: Unknown; Phase 4

Conditions: Vaginal Surgeries

Treatments: Drug: The Chlorhexidine gluconate 0.05%; Drug: 10% Povidone iodine

Study type: Interventional

Funder types: Other

Identifiers

NCT03014778

0093-15-EMC

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

The Chlorhexidine gluconate arm

Experimental group

Description:

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.

Treatment:

Drug: The Chlorhexidine gluconate 0.05%

The Povidone iodine arm

Active Comparator group

Description:

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.

Treatment:

Drug: 10% Povidone iodine