Bacteriuria, Nosocomial Infection, Urinary Tract Infection
Conditions
Keywords
Chlorhexidine, Povidone-iodine, bacteriuria, Urinary Catheterization, Urinary tract infection
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.
Interventions
DRUGPovidone-iodine
15 ml 10%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters
DRUGChlorhexidine
15 ml .2%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters
DRUGNormal saline
15 ml .9%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters
Sponsors
Mashhad University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bacteriuria day 3 | Day 3 after catheterization | Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative. |
| Bacteriuria day 7 | Day 7 after catheterization | Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative. |
| Bacteriuria day 9 | Day 9 after cathetrization | Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative. |
| Bacteriuria day 1 | day 1 after urinary catheterizatiion | Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative. |
| Bacteriuria day 5 | day 5 after catheterization | Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microorganism type day 10 | 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. |
| Microorganism Type day 5 | 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. |
Countries
Iran
Contacts
Primary ContactSeyedreza Mazlooum, Head
Outcome results
None listed