Effect of Chlorhexidine on Bacteriuria

Urinary Tract Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02032394
• Other study ID #: MUMS910212
• Status: Recruiting
• Phase: Phase 4
• First received: January 7, 2014
• Last updated: January 8, 2014
• Start date: July 2013
• Est. completion date: April 2014

Study information

• Verified date: January 2014
• Source: Mashhad University of Medical Sciences
• Contact: Seyedreza Mazlooum, Head
• Phone: +985118591511
• Email: mazlomr[@]mums.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: April 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bacteriuria
• Communicable Diseases
• Cross Infection
• Infection
• Nosocomial Infection
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• Povidone-iodine
15 ml 10%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters
• Chlorhexidine
15 ml .2%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters
• Normal saline
15 ml .9%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shahid Beheshti Hospital	Babol	Mazandaran

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bacteriuria day 1	Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.	day 1 after urinary catheterizatiion	Yes
Primary	Bacteriuria day 3	Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.	Day 3 after catheterization	Yes
Primary	Bacteriuria day 5	Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.	day 5 after catheterization	Yes
Primary	Bacteriuria day 7	Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.	Day 7 after catheterization	Yes
Primary	Bacteriuria day 9	Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.	Day 9 after cathetrization	Yes
Secondary	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	Yes
Secondary	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	Yes