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Effect of Chlorhexidine on Bacteriuria

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ClinicalTrials.gov Identifier: NCT02032394
Recruitment Status : Unknown
Verified January 2014 by Seyedreza Mazloum, Mashhad University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : January 10, 2014
Last Update Posted : January 10, 2014
Sponsor:
Information provided by (Responsible Party):
Seyedreza Mazloum, Mashhad University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Urinary Tract Infection Nosocomial Infection Bacteriuria Drug: Povidone-iodine Drug: Chlorhexidine Drug: Normal saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : July 2013
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : April 2014


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 Name: 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 Name: 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 Name: Chloride Sodium




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032394


Contacts
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Contact: Seyedreza Mazlooum, Head +985118591511 mazlomr@mums.ac.ir

Locations
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Iran, Islamic Republic of
Shahid Beheshti Hospital Recruiting
Babol, Mazandaran, Iran, Islamic Republic of
Contact: Kamran Mohammadnia       kmohamadnia@gmail.com   
Principal Investigator: Seyedreza Mazloum, Ph.D.         
Sponsors and Collaborators
Mashhad University of Medical Sciences
Investigators
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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

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Responsible Party: Seyedreza Mazloum, Faculty member of Medical Surgical Nursing Department, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02032394     History of Changes
Other Study ID Numbers: MUMS910212
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014
Keywords provided by Seyedreza Mazloum, Mashhad University of Medical Sciences:
Chlorhexidine
Povidone-iodine
bacteriuria
Urinary Catheterization
Urinary tract infection
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Cross Infection
Bacteriuria
Urologic Diseases
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Iodine
Chlorhexidine
Chlorhexidine gluconate
Cadexomer iodine
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes