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Effect of Chlorhexidine on Bacteriuria

Primary Purpose

Urinary Tract Infection, Nosocomial Infection, Bacteriuria

Status
Unknown status
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Povidone-iodine
Chlorhexidine
Normal saline
Sponsored by
Mashhad University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infection focused on measuring Chlorhexidine, Povidone-iodine, bacteriuria, Urinary Catheterization, Urinary tract infection

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Shahid Beheshti HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Chlorhexidine

Povidone-Iodine

Normal saline

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

Bacteriuria day 1
Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Bacteriuria day 3
Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Bacteriuria day 5
Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Bacteriuria day 7
Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Bacteriuria day 9
Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 7, 2014
Last Updated
January 8, 2014
Sponsor
Mashhad University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02032394
Brief Title
Effect of Chlorhexidine on Bacteriuria
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mashhad University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection, Nosocomial Infection, Bacteriuria
Keywords
Chlorhexidine, Povidone-iodine, bacteriuria, Urinary Catheterization, Urinary tract infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Chlorhexidine
Arm Type
Experimental
Arm 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.
Arm Title
Povidone-Iodine
Arm Type
Experimental
Arm 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.
Arm Title
Normal saline
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Povidone-iodine
Other Intervention Name(s)
Betadine
Intervention Description
15 ml 10%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine
Other Intervention Name(s)
CHLORHEXIDINE GLUCONATE
Intervention Description
15 ml .2%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
Chloride Sodium
Intervention Description
15 ml .9%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters
Primary Outcome Measure Information:
Title
Bacteriuria day 1
Description
Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Time Frame
day 1 after urinary catheterizatiion
Title
Bacteriuria day 3
Description
Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Time Frame
Day 3 after catheterization
Title
Bacteriuria day 5
Description
Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Time Frame
day 5 after catheterization
Title
Bacteriuria day 7
Description
Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Time Frame
Day 7 after catheterization
Title
Bacteriuria day 9
Description
Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Time Frame
Day 9 after cathetrization
Secondary Outcome Measure Information:
Title
Microorganism Type day 5
Description
Microorganism type is assessed according to result of Urine culture and is presented as the name of microorganism causing urinary infection.
Time Frame
Days 5 after catheterization
Title
Microorganism type day 10
Description
Microorganism type is assessed according to result of Urine culture and is presented as the name of microorganism causing urinary infection.
Time Frame
Day 10 after catheterization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seyedreza Mazlooum, Head
Phone
+985118591511
Email
mazlomr@mums.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seyedreza Mazloum, Ph.D.
Organizational Affiliation
Medical Surgical Nursing Department, Mashhad University of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kamran Mohammadnia, Ms.
Organizational Affiliation
Postgraduate Department, Mashhad University of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tayyebe Pourghaznein, Ms.
Organizational Affiliation
Medical Surgical Nursing Department, Mashhad University of Medical Sciences
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ebrahim Alijanpoor, Specialist
Organizational Affiliation
Anesthesia Department, Babol University of medical scienses
Official's Role
Study Director
Facility Information:
Facility Name
Shahid Beheshti Hospital
City
Babol
State/Province
Mazandaran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kamran Mohammadnia
Email
kmohamadnia@gmail.com
First Name & Middle Initial & Last Name & Degree
Seyedreza Mazloum, Ph.D.

12. IPD Sharing Statement

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Effect of Chlorhexidine on Bacteriuria

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