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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povidone-iodine | Drug | 15 ml 10%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Microorganism type day 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seyedreza Mazlooum, Head | Contact | +985118591511 | mazlomr@mums.ac.ir |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shahid Beheshti Hospital | Recruiting | Babol | Mazandaran | Iran |
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| ID | Term |
|---|---|
| D014552 | Urinary Tract Infections |
| D003428 | Cross Infection |
| D001437 | Bacteriuria |
| ID | Term |
|---|---|
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D011206 | Povidone-Iodine |
| D002710 | Chlorhexidine |
| C010882 | chlorhexidine gluconate |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
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| Chlorhexidine | Drug | 15 ml .2%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters |
|
|
| Normal saline | Drug | 15 ml .9%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters |
|
|
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 |
| 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 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014753 |
| Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D017670 | Sodium Compounds |