Catheter-Related InfectionsCISDCTNCT02472158
Chlorhexidine-Impregnated Sponge Dressing: A Clinical Trial
A study testing chlorhexidine-gel-impregnated dressing and Polyurethane film dressing in people with Catheter-Related Infections, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The purpose of this study is to compare the use of chlorhexidine-gel-impregnated dressing and the transparent polyurethane film dressing as coverage of the site of insertion of central venous catheter, in the evaluation of catheter colonization in critically ill adults patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter-Related Infections
- What is being tested?
- chlorhexidine-gel-impregnated dressing and Polyurethane film dressing
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2014to Sep 2016
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critically ill patients hospitalized carrying a short-term central venous catheter
Who cannot join
- Use of a central venous catheter with antimicrobial coating
- Suspected or confirmed bacterial infection at randomization
- Known allergic/hypersensitivity reaction to any compounds of the treatment
- Active lesions in the skin where the CVC is located and / or where the dressing of CVC is being conducted;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinical Hospital of Ribeirão Preto Medical School (HCFMRP-USP)
Ribeirão Preto, São Paulo, 14048-900
About this study
Official title: Use of Chlorhexidine-gel-Impregnated Dressing Compared to Transparent Polyurethane Film Dressing as Coverage of the Site of Insertion of Central Venous Catheter, in the Evaluation of Catheter Colonization in Critically Ill Adults Patients: A Randomized Controlled Trial
The purpose of this study is to compare the use of chlorhexidine-gel-impregnated dressing and the transparent polyurethane film dressing as coverage of the site of insertion of central venous catheter, in the evaluation of catheter colonization in critically ill adults patients.
- Conditions
- Catheter-Related Infections
- Being tested
- chlorhexidine-gel-impregnated dressing, Polyurethane film dressing
- Keywords
- Bandages, Central Venous Catheters, Catheter-Related Infections
- Medical subject headings
- Catheter-Related Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chlorhexidine-gel-impregnated dressingDevice
Also called 3M Tegaderm CHG IV securement dressing™
Chlorhexidine Patients receive a chlorhexidine-gel-impregnated dressing ( 3M Tegaderm CHG IV securement dressing™ ) after insertion of central venous catheter
Polyurethane film dressingDevice
Also called 3M Tegaderm IV dressing™
Polyurethane film dressing Patients receive a transparent polyurethane film dressing (3M Tegaderm IV dressing™) after insertion of central venous catheter.
| Study group | Role | What they receive |
|---|---|---|
| chlorhexidine-gel-impregnated dressing | Experimental | Chlorhexidine Patients receive a chlorhexidine-gel-impregnated dressing ( 3M Tegaderm CHG IV securement dressing™ ) after insertion of central venous catheter Receives: Device: chlorhexidine-gel-impregnated dressing |
| Polyurethane film dressing | Active comparator | Polyurethane film dressing Patients receive a transparent polyurethane film dressing (3M Tegaderm IV dressing™) after insertion of central venous catheter. Receives: Device: Polyurethane film dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter Colonization
With aseptic technique, the central venous catheter will be withdrawn and a 5 centimeters distal portion of the catheter will be cut and conditioned in sterile test tube and sent to the microbiology laboratory. It will be considered a Catheter Colonization a significant growth of one or more microorganism in a semiquantitative culture of the catheter tip. It is according to the Clinical Practice Guidelines for the Diagnosis and management of Intravascular Catheter- Related Infection: 2009 Update by the Infectious Diseases Society of America
Measured: Participants will be followed from placement until the withdraw of the central venous catheter, an expected average of 3 weeks.
Secondary outcomes (2)
Microbiological Exit site Infection
With aseptic technique, a swab will be collected before removal of central venous catheter, the swab will be moistened with sterile saline and rolled for about 2 cm around the exit site. The material will be conditioned in sterile test tube and sent to the microbiology laboratory. It will be considered a Microbiological Exit Site Infection the exudate at catheter exit site yields a microorganism. According to Clinical Practice Guideline for Diagnosis and Management of intravascular Catheter-Related Infection: 2009 Update by the Infectious Diseases Society of America
Measured: Participants will be followed from placement until the withdraw of central venous catheter, an expected average of 3 weeks
Clinical Exit Site Infection
Erythema, induration, and/or tenderness within 2 cm of the catheter exit site, according to Clinical Practice Guidelines for the diagnosis and management of intravascular Catheter-Related Infection: 2009 Update by the infectious diseases Society of America.
Measured: Participants will be followed from placement until the withdraw of central venous catheter, an expected average of 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startApr 2014
- Primary completionOct 2015
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter-Related InfectionsStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Salles Margatho, University of Sao Paulo
- Investigators
- Amanda Salles Margatho, PhD student, Study chair, University of São Paulo at Ribeirão Preto College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02472158
- Sponsor's protocol ID
- CISD-15
- Acronym
- CISDCT
- Status last verified
- May 2016
- First submitted
- 26 Jan 2015
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Chlorhexidine-gel-Impregnated Dressing Compared to Transparent Polyurethane Film Dressing as Coverage of the Site of Insertion of Central Venous Catheter, in the Evaluation of Catheter Colonization in Critically Ill Adults Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02472158
- Acronym / sponsor ID
- CISDCT / CISD-15
- Conditions
- Catheter-Related Infections
- Keywords
- Bandages, Central Venous Catheters, Catheter-Related Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Sep 2016 (estimated)
- First posted
- 15 Jun 2015 (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.
The purpose of this study is to compare the use of chlorhexidine-gel-impregnated dressing and the transparent polyurethane film dressing as coverage of the site of insertion of central venous catheter, in the evaluation of catheter colonization in critically ill adults patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chlorhexidine-gel-impregnated dressing | Experimental | Device: chlorhexidine-gel-impregnated dressingChlorhexidine Patients receive a chlorhexidine-gel-impregnated dressing ( 3M Tegaderm CHG IV securement dressing™ ) after insertion of central venous catheter |
| Polyurethane film dressing | Active comparator | Device: Polyurethane film dressingPolyurethane film dressing Patients receive a transparent polyurethane film dressing (3M Tegaderm IV dressing™) after insertion of central venous catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Critically ill patients hospitalized carrying a short-term central venous catheter
Key exclusion criteria (4 listed)
- Use of a central venous catheter with antimicrobial coating
- Suspected or confirmed bacterial infection at randomization
- Known allergic/hypersensitivity reaction to any compounds of the treatment
- Active lesions in the skin where the CVC is located and / or where the dressing of CVC is being conducted;
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 |
|---|---|---|
| chlorhexidine-gel-impregnated dressingAlso: 3M Tegaderm CHG IV securement dressing™Chlorhexidine Patients receive a chlorhexidine-gel-impregnated dressing ( 3M Tegaderm CHG IV securement dressing™ ) after insertion of central venous catheter | Device | chlorhexidine-gel-impregnated dressing |
| Polyurethane film dressingAlso: 3M Tegaderm IV dressing™Polyurethane film dressing Patients receive a transparent polyurethane film dressing (3M Tegaderm IV dressing™) after insertion of central venous catheter. | Device | Polyurethane film dressing |
Primary outcome
Catheter Colonization
Time frame: Participants will be followed from placement until the withdraw of the central venous catheter, an expected average of 3 weeks.
With aseptic technique, the central venous catheter will be withdrawn and a 5 centimeters distal portion of the catheter will be cut and conditioned in sterile test tube and sent to the microbiology laboratory. It will be considered a Catheter Colonization a significant growth of one or more microorganism in a semiquantitative culture of the catheter tip. It is according to the Clinical Practice Guidelines for the Diagnosis and management of Intravascular Catheter- Related Infection: 2009 Update by the Infectious Diseases Society of America
2 secondary outcomes
Microbiological Exit site Infection
Time frame: Participants will be followed from placement until the withdraw of central venous catheter, an expected average of 3 weeks
Clinical Exit Site Infection
Time frame: Participants will be followed from placement until the withdraw of central venous catheter, an expected average of 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
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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.
Amanda Salles Margatho, PhD student study chair
University of São Paulo at Ribeirão Preto College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chlorhexidine-gel-impregnated dressing and Polyurethane film dressing in people with Catheter-Related Infections, run by University of Sao Paulo at 1 site in Brazil.
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 1 inclusion and 4 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 13 May 2016. 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 Brazil. 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catheter Colonization (time frame: Participants will be followed from placement until the withdraw of the central venous catheter, an expected average of 3 weeks.). 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 13 May 2016.