Clinical trial NCT02032394: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Urinary Tract Infection
Nosocomial Infection
Bacteriuria
Keywords: Chlorhexidine
Povidone-iodine
bacteriuria
Urinary Catheterization
Urinary tract infection
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Bacteriuria day 1
timeFrame: day 1 after urinary catheterizatiion
measure: Bacteriuria day 3
timeFrame: Day 3 after catheterization
measure: Bacteriuria day 5
timeFrame: day 5 after catheterization
measure: Bacteriuria day 7
timeFrame: Day 7 after catheterization
measure: Bacteriuria day 9
timeFrame: Day 9 after cathetrization
Secondary outcomes:
measure: Microorganism Type day 5
timeFrame: Days 5 after catheterization
measure: Microorganism type day 10
timeFrame: Day 10 after catheterization
Other outcomes:
Locations:
city: Babol
country: Iran, Islamic Republic of
facility: Shahid Beheshti Hospital
state: Mazandaran
Study officials:
affiliation: Medical Surgical Nursing Department, Mashhad University of Medical Sciences
name: Seyedreza Mazloum, Ph.D.
role: STUDY_CHAIR
affiliation: Postgraduate Department, Mashhad University of Medical Sciences
name: Kamran Mohammadnia, Ms.
role: STUDY_DIRECTOR
affiliation: Medical Surgical Nursing Department, Mashhad University of Medical Sciences
name: Tayyebe Pourghaznein, Ms.
role: STUDY_DIRECTOR
affiliation: Anesthesia Department, Babol University of medical scienses
name: Ebrahim Alijanpoor, Specialist
role: STUDY_DIRECTOR
References: