Efficacy Comparison of Two Vaginal Solutions for Preoperative Use in Candidate Women for Vaginal Surgeries
试验速览
- 阶段
- 4 期
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Changing in the number of colonies that grew at every stage
研究概览
简要总结
This study is necessary in order to provide proof the effectiveness of Chlorhexidine gluconate and its safety.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
The Chlorhexidine gluconate arm
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.
干预措施: The Chlorhexidine gluconate 0.05% (Drug)
The Povidone iodine arm
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.
干预措施: 10% Povidone iodine (Drug)
结局指标
主要结局
Changing in the number of colonies that grew at every stage
时间窗: Before the washing, 10 minutes after washing, 30 minutes after washing.
次要结局
- 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.)
研究者
Sharon Tzemach
Dr
HaEmek Medical Center, Israel