Effect of Chlorhexidine on Bacteriuria

Mashhad University of Medical Sciences

Status and phase: Unknown; Phase 4

Conditions: Nosocomial Infection; Urinary Tract Infection; Bacteriuria

Treatments: Drug: Normal saline; Drug: Chlorhexidine; Drug: Povidone-iodine

Study type: Interventional

Funder types: Other

Identifiers

NCT02032394

MUMS910212

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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105 participants in 3 patient groups

Chlorhexidine

Experimental group

Description:

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.

Treatment:

Drug: Chlorhexidine

Povidone-Iodine

Experimental group

Description:

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.

Treatment:

Drug: Povidone-iodine

Normal saline

Active Comparator group

Description:

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.

Treatment:

Drug: Normal saline