Urinary Tract Infection Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 105 |
Est. completion date | April 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Shahid Beheshti Hospital | Babol | Mazandaran |
Lead Sponsor | Collaborator |
---|---|
Mashhad University of Medical Sciences |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bacteriuria day 1 | Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative. | day 1 after urinary catheterizatiion | Yes |
Primary | Bacteriuria day 3 | Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative. | Day 3 after catheterization | Yes |
Primary | Bacteriuria day 5 | Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative. | day 5 after catheterization | Yes |
Primary | Bacteriuria day 7 | Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative. | Day 7 after catheterization | Yes |
Primary | Bacteriuria day 9 | Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative. | Day 9 after cathetrization | Yes |
Secondary | 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. | Days 5 after catheterization | Yes |
Secondary | 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. | Day 10 after catheterization | Yes |
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