Comparison of the Effect of Applying Povidone-iodine and Chlorhexidine Solutions for Perinea Washing on Bacteriuria Rate and Type in Patients With Urinary Catheter in Intensive Care Unit
试验速览
- 阶段
- 4 期
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Bacteriuria day 1
研究概览
简要总结
This study is conducted to determine and compare the effect of applying Povidone-iodine and Chlorhexidine solutions for perinea washing on bacteriuria rate and type in patients with urinary catheter in intensive care unit.
详细描述
This is a double blind randomized study with control group. The population is patients in intensive care unit of Shahid Beheshti hospital of Babol city. Main include criteria are 18-55 years old, need to having urine catheter for 10 days at least and no urinary infection in catheterization time. Main exclude criteria are appearing genital wound, allergic or dermatitis disorders. Sample size include 105 patients dividing in three equal groups of Povidone-iodine, Chlorhexidine and Normal saline randomly. Interventions are Washing perinea area and catheter first 5 centimeters by 15 ml of Povidone-iodine 10%, Chlorhexidine .2% or Normal saline .9%, 3 times a day for 10 days. Urine analysis are performed in days 1,3,5,7 and 9 after catheterization and urine cultures are performed in days 5 and 10 after catheterization for detection of bacteriuria and microorganism type.
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)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must need a urinary catheter for 10 days at least
- •Must have 18-55 years old
- •Men subjects must doing circumcision already
- •Urinary catheter must be apply in a standard method by researcher or via her supervision
排除标准
- •No more tendency of patient or his/her significant other for continuing study
- •Malignant disease such as prostate or uterine cancer
- •History of recurrent urinary infection
- •Congenital urinary system disorders
- •history of allergy
- •Immunodeficiency disorders
- •Urinary system intervention in past sixth months
- •Urinary infection at study start
- •Positive urine analysis or urine culture results in first 3 days of study
- •Abdominal or pelvic surgery
- •Women having period during study
- •Any allergic reaction or dermatitis resulted from applying study solutions
- •Appearing genital wounds
- •Diabetes mellitus
- •Wound in genital area
- •Discharging, transferring or dying in first week of study
研究组 & 干预措施
Chlorhexidine
Washing of perineal area and proximal first 5 centimeters of catheter from mea, done by 15 ml of Chlorhexidine 0.2%, 3 times a day for 10 days.
干预措施: Chlorhexidine (Drug)
Povidone-Iodine
Washing of perineal area and proximal first 5 centimeters of catheter from mea, done by 15 ml of Povidone-iodine 10%, 3 times a day for 10 days.
干预措施: Povidone-iodine (Drug)
Normal saline
Washing of perineal area and proximal first 5 centimeters of catheter from mea, done by 15 ml of Normal saline 0.9%, 3 times a day for 10 days.
干预措施: Normal saline (Drug)
结局指标
主要结局
Bacteriuria day 1
时间窗: day 1 after urinary catheterizatiion
Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Bacteriuria day 3
时间窗: Day 3 after catheterization
Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Bacteriuria day 5
时间窗: day 5 after catheterization
Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Bacteriuria day 7
时间窗: Day 7 after catheterization
Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Bacteriuria day 9
时间窗: Day 9 after cathetrization
Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
次要结局
- Microorganism Type day 5(Days 5 after catheterization)
- Microorganism type day 10(Day 10 after catheterization)
研究者
Seyedreza Mazloum
Faculty member of Medical Surgical Nursing Department
Mashhad University of Medical Sciences