Effect of Chlorhexidine on Bacteriuria

Phase 4

• Conditions: Urinary Tract Infection; Nosocomial Infection; Bacteriuria
• Interventions: Drug: Normal saline; Drug: Povidone-iodine; Drug: Chlorhexidine

• Registration Number: NCT02032394
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-07
• Status Verified: 2014-01
• Study First Submitted: 2014-01-07
• Study First Submitted QC: 2014-01-08
• Last Update Submitted: 2014-01-08
• Study First Posted: 2014-01-10
• Last Update Posted: 2014-01-10
• Primary Completion: 2014-02
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	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.
Povidone-Iodine	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.
Chlorhexidine	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.

Primary Outcome Measures

Name	Time	Method
Bacteriuria day 1	day 1 after urinary catheterizatiion	Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Bacteriuria day 3	Day 3 after catheterization	Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Bacteriuria day 5	day 5 after catheterization	Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Bacteriuria day 7	Day 7 after catheterization	Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Bacteriuria day 9	Day 9 after cathetrization	Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.

Secondary Outcome Measures

Name	Time	Method
Microorganism Type day 5	Days 5 after catheterization	Microorganism type is assessed according to result of Urine culture and is presented as the name of microorganism causing urinary infection.
Microorganism type day 10	Day 10 after catheterization	Microorganism type is assessed according to result of Urine culture and is presented as the name of microorganism causing urinary infection.

Trial Locations

Locations (1)

Shahid Beheshti Hospital; 🇮🇷 Babol, Mazandaran, Iran, Islamic Republic of