Effect of Chlorhexidine on Bacteriuria

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Urinary Tract Infection, Nosocomial Infection, Bacteriuria

Intervention / Treatment
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* Drug: Povidone-iodine
* Drug: Chlorhexidine
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine<br>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. | Drug: Chlorhexidine<br>* 15 ml .2%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters<br>* Other names: CHLORHEXIDINE GLUCONATE;|
| Experimental: Povidone-Iodine<br>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. | Drug: Povidone-iodine<br>* 15 ml 10%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters<br>* Other names: Betadine;|
| Active Comparator: Normal saline<br>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. | Drug: Normal saline<br>* 15 ml .9%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters<br>* Other names: Chloride Sodium;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacteriuria day 1 | Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative. | day 1 after urinary catheterizatiion | 
| Bacteriuria day 3 | Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative. | Day 3 after catheterization | 
| Bacteriuria day 5 | Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative. | day 5 after catheterization | 
| Bacteriuria day 7 | Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative. | Day 7 after catheterization | 
| Bacteriuria day 9 | Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative. | Day 9 after cathetrization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microorganism Type day 5 | Microorganism type is assessed according to result of Urine culture and is presented as the name of microorganism causing urinary infection. | Days 5 after catheterization | 
| Microorganism type day 10 | Microorganism type is assessed according to result of Urine culture and is presented as the name of microorganism causing urinary infection. | Day 10 after catheterization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chlorhexidine, Povidone-iodine, bacteriuria, Urinary Catheterization, Urinary tract infection