Urinary Tract InfectionPhase 4NCT02032394
Effect of Chlorhexidine on Bacteriuria
A Phase 4 study testing Povidone-iodine, Chlorhexidine and Normal saline in people with Urinary Tract Infection and Nosocomial Infection, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Urinary Tract Infection, Nosocomial Infection, Bacteriuria
- What is being tested?
- Povidone-iodine, Chlorhexidine and Normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteIran
- Study dates
- Jul 2013to Apr 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Shahid Beheshti Hospital
Babol, Mazandaran
Kamran Mohammadnia, kmohamadnia@gmail.com
Seyedreza Mazloum, Ph.D.
About this study
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.
Read the 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.
- Conditions
- Urinary Tract Infection, Nosocomial Infection, Bacteriuria
- Being tested
- Povidone-iodine, Chlorhexidine, Normal saline
- Keywords
- Chlorhexidine, Povidone-iodine, bacteriuria, Urinary Catheterization, Urinary tract infection
- Medical subject headings
- Urinary Tract Infections, Cross Infection, Bacteriuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone-iodineDrug
Also called Betadine
15 ml 10%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters
ChlorhexidineDrug
Also called CHLORHEXIDINE GLUCONATE
15 ml .2%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters
Normal salineDrug
Also called Chloride Sodium
15 ml .9%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacteriuria day 1
Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Measured: day 1 after urinary catheterizatiion
Bacteriuria day 3
Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Measured: Day 3 after catheterization
Bacteriuria day 5
Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Measured: day 5 after catheterization
Bacteriuria day 7
Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Measured: Day 7 after catheterization
Bacteriuria day 9
Bacteriuria is assessed according to result of urine analysis and is presented as positive or negative.
Measured: Day 9 after cathetrization
Secondary outcomes (2)
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.
Measured: Days 5 after catheterization
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.
Measured: Day 10 after catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startJul 2013
- Primary completionFeb 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyedreza Mazloum, Mashhad University of Medical Sciences
- Investigators
- Seyedreza Mazloum, Ph.D., Study chair, Medical Surgical Nursing Department, Mashhad University of Medical SciencesKamran Mohammadnia, Ms., Study director, Postgraduate Department, Mashhad University of Medical SciencesTayyebe Pourghaznein, Ms., Study director, Medical Surgical Nursing Department, Mashhad University of Medical SciencesEbrahim Alijanpoor, Specialist, Study director, Anesthesia Department, Babol University of medical scienses
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032394
- Sponsor's protocol ID
- MUMS910212
- Status last verified
- Jan 2014
- First submitted
- 7 Jan 2014
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02032394
- Acronym / sponsor ID
- MUMS910212
- Conditions
- Urinary Tract Infection, Nosocomial Infection, Bacteriuria
- Keywords
- Chlorhexidine, Povidone-iodine, bacteriuria, Urinary Catheterization, Urinary tract infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine | Experimental | Drug: ChlorhexidineWashing 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 | Drug: Povidone-iodineWashing 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 | Drug: Normal salineWashing 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Povidone-iodineAlso: Betadine15 ml 10%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters | Drug | Povidone-Iodine |
| ChlorhexidineAlso: CHLORHEXIDINE GLUCONATE15 ml .2%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters | Drug | Chlorhexidine |
| Normal salineAlso: Chloride Sodium15 ml .9%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters | Drug | Normal saline |
Primary outcome
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.
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.
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.
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.
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.
2 secondary outcomes
Microorganism Type day 5
Time frame: Days 5 after catheterization
Microorganism type day 10
Time frame: Day 10 after catheterization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seyedreza Mazloum, Ph.D. study chair
Medical Surgical Nursing Department, Mashhad University of Medical Sciences
Kamran Mohammadnia, Ms. study director
Postgraduate Department, Mashhad University of Medical Sciences
Tayyebe Pourghaznein, Ms. study director
Medical Surgical Nursing Department, Mashhad University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Povidone-iodine, Chlorhexidine and Normal saline in people with Urinary Tract Infection and Nosocomial Infection, run by Mashhad University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyedreza Mazlooum, Head (+985118591511, mazlomr@mums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacteriuria day 1 (time frame: day 1 after urinary catheterizatiion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2014; AzTrials last refreshed its copy on 30 Oct 2026.