Vaginal Surgeries
Conditions
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.
Interventions
DRUGThe Chlorhexidine gluconate 0.05%
Washing vagina pre- operatively with Chlorhexidine gluconate 0.05%
Washing vagina pre- operatively with 10% Povidone iodine
Sponsors
HaEmek Medical Center, Israel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | 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
| Measure | 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. |
Countries
Israel
Contacts
Primary ContactSharon Tzemah, MD
Backup ContactMichael Gross, MD
Outcome results
None listed