Chlorhexidine Gluconate Versus Povidone Iodine for Vaginal Surgical Preparation for Urogynecological Procedures
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- Rate of Urinary Tract Infection
研究概览
简要总结
This is a randomized controlled trial to determine if there is a difference between chlorhexidine gluconate and povidone iodine vaginal preparations for urogynecological surgery post operative infections.
详细描述
The purpose of this randomized controlled trial is to determine whether there is a difference in efficacy of two of the most common commercially available vaginal surgical preparations. The first objective is to determine whether chlorhexidine gluconate is non-inferior to povidone iodine with respect to post-operative infections including urinary tract infections (both culture proven and empirically treated) and surgical site infections (as defined by the Centers for Disease Control). The second objective is to determine whether chlorhexidine gluconate is non-inferior to povidone iodine with respect to vulvar and vaginal irritation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Participants will be anesthetized during the intervention and will not be informed of the arm of their randomization
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
- •Female Subjects >18 years of age
- •English or Spanish speaking/reading
- •Must be able to provide informed consent
- •Undergoing urogynecologic procedures or surgery
排除标准
- •Pregnant - all patients are verified regarding pregnancy status prior to gynecologic surgical intervention at all sites of surgery - for patients who are premenopausal and have a uterus, a urine pregnancy test is administered in the preoperative setting. Pregnancy status is also determined prior to this in the office setting by interview and patient provided history prior to offering surgery to the patient.
- •Inability to return for follow-up visits
- •No concurrent need for vaginal antisepsis, such as cases of sacral neuromodulation
- •Lack of telephone
- •Known allergy to either antiseptic agent
- •Prisoners will not be eligible to participate in this study
研究组 & 干预措施
Chlorhexidine gluconate
Chlorhexidine gluconate 2% vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
干预措施: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. (Drug)
Povidone Iodine
Povidone iodine vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
干预措施: Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery. (Drug)
结局指标
主要结局
Rate of Urinary Tract Infection
时间窗: 2 weeks post operatively
Urinary tract infection as defined by positive urine culture of \>10,000 cfu, or empirically treated symptoms.
次要结局
- Vaginal Irritation(Post operative day 1)
- Rate of Surgical Site Infection(14 days postoperatively)