Effect of Chlorhexidine on Bacteriuria

January 8, 2014 updated by: Seyedreza Mazloum, Mashhad University of Medical Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

105

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: Chlorhexidine
15 ml .2%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters
Other Names:
  • CHLORHEXIDINE GLUCONATE
EXPERIMENTAL: 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.
Drug: Povidone-iodine
15 ml 10%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters
Other Names:
  • Betadine
ACTIVE_COMPARATOR: 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.
Drug: Normal saline
15 ml .9%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters
Other Names:
  • Chloride Sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bacteriuria day 1
Time Frame: day 1 after urinary catheterizatiion
Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
day 1 after urinary catheterizatiion
Bacteriuria day 3
Time Frame: Day 3 after catheterization
Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Day 3 after catheterization
Bacteriuria day 5
Time Frame: day 5 after catheterization
Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
day 5 after catheterization
Bacteriuria day 7
Time Frame: Day 7 after catheterization
Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Day 7 after catheterization
Bacteriuria day 9
Time Frame: Day 9 after cathetrization
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
Time Frame: 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.
Days 5 after catheterization
Microorganism type day 10
Time Frame: 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.
Day 10 after catheterization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mashhad University of Medical Sciences

Investigators

  • Study Chair: Seyedreza Mazloum, Ph.D., Medical Surgical Nursing Department, Mashhad University of Medical Sciences
  • Study Director: Kamran Mohammadnia, Ms., Postgraduate Department, Mashhad University of Medical Sciences
  • Study Director: Tayyebe Pourghaznein, Ms., Medical Surgical Nursing Department, Mashhad University of Medical Sciences
  • Study Director: Ebrahim Alijanpoor, Specialist, Anesthesia Department, Babol University of medical scienses

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ANTICIPATED)

February 1, 2014

Study Completion (ANTICIPATED)

April 1, 2014

Study Registration Dates

First Submitted

January 7, 2014

First Submitted That Met QC Criteria

January 8, 2014

First Posted (ESTIMATE)

January 10, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 8, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUMS910212

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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