Effect of Chlorhexidine on Bacteriuria

NCT ID: NCT02032394

Last Updated: 2014-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-04-30

Brief Summary

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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

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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.

Conditions

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Urinary Tract Infection Nosocomial Infection Bacteriuria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Chlorhexidine

Intervention Type DRUG

15 ml .2%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters

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.

Group Type EXPERIMENTAL

Povidone-iodine

Intervention Type DRUG

15 ml 10%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters

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.

Group Type ACTIVE_COMPARATOR

Normal saline

Intervention Type DRUG

15 ml .9%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters

Interventions

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Povidone-iodine

15 ml 10%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters

Intervention Type DRUG

Chlorhexidine

15 ml .2%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters

Intervention Type DRUG

Normal saline

15 ml .9%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters

Intervention Type DRUG

Other Intervention Names

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Betadine CHLORHEXIDINE GLUCONATE Chloride Sodium

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Seyedreza Mazloum

Faculty member of Medical Surgical Nursing Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seyedreza Mazloum, Ph.D.

Role: STUDY_CHAIR

Medical Surgical Nursing Department, Mashhad University of Medical Sciences

Kamran Mohammadnia, Ms.

Role: STUDY_DIRECTOR

Postgraduate Department, Mashhad University of Medical Sciences

Tayyebe Pourghaznein, Ms.

Role: STUDY_DIRECTOR

Medical Surgical Nursing Department, Mashhad University of Medical Sciences

Ebrahim Alijanpoor, Specialist

Role: STUDY_DIRECTOR

Anesthesia Department, Babol University of medical scienses

Locations

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Shahid Beheshti Hospital

Babol, Mazandaran, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Seyedreza Mazlooum, Head

Role: CONTACT

+985118591511

Facility Contacts

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Kamran Mohammadnia

Role: primary

Other Identifiers

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MUMS910212

Identifier Type: -

Identifier Source: org_study_id

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