A Randomized Trial of Vaginal Prep Solutions to Reduce Bacteria Colony Counts in Patients Having a Vaginal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Vaginal Colony Counts (Anaerobic)
研究概览
简要总结
This is a randomized trial comparing the effectiveness of 4 vaginal prep solutions (betadine, baby shampoo, TechniCare and Peridex) on reducing bacterial colony counts during surgery preparation. Women undergoing a vaginal surgery will be enrolled into the trial prior to surgery. Target sample size per group is 15 patients. During standard surgical prep, a vaginal swab will be taken to assess the initial colony counts for aerobic and anaerobic bacteria. After the initial swab, the incision point will be prepared using one of the prep 4 solutions (betadine, baby shampoo, TechniCare or Peridex). After a predefined 10 minutes, the area will be re-swabbed to determine pre-incision colony counts. A third swab will be collected after incision closure. Laboratory analyses for raw colony counts, sensitivities, identification (using MALDI-TOF) will be performed. The results are expected to show that there will be reduced colony counts at the pre-incision point with baby shampoo having the least reduction, followed by betadine and TechniCare, then Peridex. Patient reported outcomes for vaginal itching and burning as well as patient report of any treatment for vaginal infection will be collected by telephone at 2 days, 2 weeks and 1 month post-surgery.
详细描述
BACKGROUND AND LITERATURE REVIEW Antiseptic preparation for surgical incision sites has greatly reduced postoperative infections. However, surgical site infections (SSI) are still the leading cause of hospitalizations after surgery. With the application of antiseptic preparation, a reduction in bacterial counts follows. The rate at which the bacterial counts rise between preparation and incision may be of variation depending on the surgical antiseptic scrub.
Betadine (Povidone- iodine), Peridex (Chlorhexidine), baby shampoo and TechniCare (chloroxynel) are all surgical scrubs approved for the preparation of vaginal access surgeries. While there has been controversy on the use of Chlorohexidine for vaginal preparation surgery, due to its labeling as a cause for irritation, studies have shown that when 2-4% Chlorhexidine is used in the vaginal area there are little to no signs of irritation and the bacteria counts post incision are less than the bacterial counts for povidone iodine1,2. Baby shampoo can also be used as an effective antiseptic scrub with no irritation and no statistical difference in bacterial count reduction as compared to povidone-iodine3. Little research has been done to look at the antiseptic power of Chloroxynel in vaginal surgeries. However, when used as a root canal antiseptic it can reduce bacteria counts by 99.9%4. This is illustrative of its capability to reduce bacteria on a mucus membrane similar to the vagina.
There is literature that shows the antiseptic power of Betadine, Peridex, Baby shampoo and TechniCare for post-incisional bacteria counts, but little is known about the pre-incisional power of these scrubs for vaginal access surgeries.
SPECIFIC AIMS OR OBJECTIVES The aim of this study is to understand the power of vaginal surgical scrubs before incision. This will be done by collecting bacterial samples both before and 10 minutes after antiseptic preparation and after incision closure, along with follow-up data of irritation, infection post-surgery, and infection risk factors of each patient.
SIGNIFICANCE TO PATIENT, INSTITUTION, PROFESSION, OR ALL Vaginal preparation research provides benefitted knowledge to hospitals and physicians in the prevention of surgical site infections (SSI). This specific project will provide insight regarding the bacteria-eliminating power of four different surgical scrubs used on the vaginal mucous membrane, pre-incision. There is potential for this study to determine the most effective scrub for vaginal surgeries, as well as correlate pre-incisional bacterial counts and the post-procedure bacterial counts with likelihood of surgical site infections. The information collected from this study could benefit future patients and hospitals alike in terms of reducing the risk of SSI's. The risks of this study could be unidentified allergies to any of the surgical scrubs, or a loss of patient data. These are unlikely risks due to the protocol of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients and laboratory staff will not know which group cases have been assigned
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All procedures that require a vaginal incision will be included in the study, these being procedures like hysterectomies and reconstruction surgery.
排除标准
- •Non-incisional procedures like dilation and curettage will be excluded.
- •Revision surgeries will also be excluded to decrease any complications.
研究组 & 干预措施
Baby shampoo
Baby shampoo used for surgical site prep
干预措施: Baby shampoo (Other)
TechniCare (chloroxynel)
TechniCare used for surgical site prep
干预措施: TechniCare (Other)
Betadine (Povidone- iodine)
Betadine used for surgical site prep
干预措施: Betadine (Other)
Peridex (Chlorhexidine)
Peridex used for surgical site prep
干预措施: Peridex (Other)
结局指标
主要结局
Vaginal Colony Counts (Anaerobic)
时间窗: 2 timepoints: prior to surgical prep, and 10 min after surgical prep
anaerobic culture colony counts - change in anaerobic colony counts from prior to surgical prep to 10 minutes after surgical prep
Vaginal Colony Counts (Aerobic)
时间窗: 2 timepoints: prior to surgical prep, and 10 min after surgical prep
aerobic culture colony counts - change in aerobic colony counts from prior to surgical prep to 10 minutes after surgical prep
次要结局
- Vaginal Colony Counts (Aerobic)(2 timepoints: 10 min after surgical prep (prior to incision), and after incision closure)
- Vaginal Colony Counts (Fungal)(2 timepoints: 10 min after surgical prep (prior to incision), and after incision closure)
- Vaginal Colony Counts (Anaerobic)(2 timepoints: 10 min after surgical prep (prior to incision), and after incision closure)
- Vaginal Colony Counts (Fungal)(2 timepoints: prior to surgical prep, and 10 min after surgical prep)
