Effect of Chlorhexidine on Bacteriuria

NCT02032394 | Unknown Phase 4

• 1 other identifier: MUMS910212
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Urinary Tract Infection; Nosocomial Infection; Bacteriuria

Keywords

Chlorhexidine; Povidone-iodine; bacteriuria; Urinary Catheterization; Urinary tract infection

Outcome Measures

Primary Outcomes (5)

• Bacteriuria day 1

  Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.

  day 1 after urinary catheterizatiion

• Bacteriuria day 3

  Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.

  Day 3 after catheterization

• Bacteriuria day 5

  Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.

  day 5 after catheterization

• Bacteriuria day 7

  Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.

  Day 7 after catheterization

• Bacteriuria day 9

  Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.

  Day 9 after cathetrization

Secondary Outcomes (2)

• Microorganism Type day 5

  Days 5 after catheterization

• Microorganism type day 10

  Day 10 after catheterization

Study Arms (3)

Chlorhexidine

EXPERIMENTAL

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

Povidone-Iodine

EXPERIMENTAL

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

Normal saline

ACTIVE COMPARATOR

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

Interventions

Povidone-iodine DRUG

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

Also known as: Betadine

Povidone-Iodine

Chlorhexidine DRUG

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

Also known as: CHLORHEXIDINE GLUCONATE

Chlorhexidine

Normal saline DRUG

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

Also known as: Chloride Sodium

Normal saline

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mashhad University of Medical Sciences: lead

Study Sites (1)

Shahid Beheshti Hospital

Babol, Mazandaran, Iran

RECRUITING

MeSH Terms

Conditions

Urinary Tract Infections; Cross Infection; Bacteriuria

Interventions

Povidone-Iodine; Chlorhexidine; chlorhexidine gluconate; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Biguanides; Guanidines; Amidines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Officials

• Seyedreza Mazloum, Ph.D.

  Medical Surgical Nursing Department, Mashhad University of Medical Sciences

  STUDY CHAIR

• 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 DIRECTOR

Central Study Contacts

Seyedreza Mazlooum, Head

CONTACT

+985118591511; mazlomr@mums.ac.ir

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty member of Medical Surgical Nursing Department

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 10, 2014
• Study Start: July 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2014
• Last Updated: January 10, 2014

Record last verified: 2014-01

Locations

IR (1)