Intravascular Catheter ColonizationPhase 4EAC-UCINCT01733940
Efficacy of Tegaderm-CHG® Dressing vs. Tegaderm-IV® Dressing
A Phase 4 study testing Application of a dressing with clorhexidine gluconate in intravascular catheters. and Application of a dressing without clorhexidine gluconate in people with Intravascular Catheter Colonization, run by Hospital Central de la Defensa Gómez Ulla at 1 site in Spain.
Trial summary
Introduction: The vascular catheter-related bacteremia (BRC) is a major health problem in intensive care units. The use of dressings containing chlorhexidine gluconate (CHG) can decrease the catheters colonization, closely related to infection thereof. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intravascular Catheter Colonization
- What is being tested?
- Application of a dressing with clorhexidine gluconate in intravascular catheters. and Application of a dressing without clorhexidine gluconate
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2012to Jun 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: over 18 years, indicating the central intravascular catheter implantation in the ICU or in the operating room, prior informed consent -
Exclusion Criteria:positive blood culture at the time of catheter implantation.
-
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Central Hospital of the Defense
Madrid, Madrid, 28047
ana isabel lopez figueras, alopfi1@oc.mde.es
Ana isabel López figueras
About this study
Official title: Efficacy of Tegaderm-CHG® Dressing vs. Tegaderm-IV® Dressing in the Reduction of Central Catheter Colonization in Patients of the Intensive Care Unit of the University "Gómez Ulla" Hospital.
Introduction: The vascular catheter-related bacteremia (BRC) is a major health problem in intensive care units. The use of dressings containing chlorhexidine gluconate (CHG) can decrease the catheters colonization, closely related to infection thereof.
Objective: To determine the efficacy of the dressing "Tegaderm CHG" dressings versus "Tegaderm IV" dressings in reducing the risk of colonization of central intravascular catheters in the intensive care unit (ICU).
Read more
Methods: Randomized controlled trial with blinding professional who reviews the main outcome. The study included patients over 18 years, indicating the central intravascular catheter implantation in the ICU or in the operating room, prior informed consent. Excluding subjects with positive blood culture at the time of catheter implantation.
The estimated sample size is 398 patients, with a confidence level of 95% and a statistical power of 80%. The study protocol was approved by the ethics committee of the hospital.
Be made prospectively followed subjects from study entry until catheter removal collecting information on age, sex, APACHEII, antibiotic therapy, duration of catheter insertion site and removal, reason for withdrawal and microbiological information.
For statistical analysis, a model is adjusted multivariate logistic regression, determining the interaction of variables with the likelihood ratio test and confusion by switching between the crude and adjusted effect greater than 10%.
Results and conclusions: The recruitment has started in November 2012 and is scheduled for completion in March 2013. This study will determine whether these new dressings are effective in our environment.
- Conditions
- Intravascular Catheter Colonization
- Being tested
- Application of a dressing with clorhexidine gluconate in intravascular catheters., Application of a dressing without clorhexidine gluconate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of a dressing with clorhexidine gluconate in intravascular catheters.Device
Application of a dressing without clorhexidine gluconateDevice
| Study group | Role | What they receive |
|---|---|---|
| "Tegaderm CHG" Dressing | Experimental | This arm is receiving a clorhexidine dressing for intravascular catheters. Receives: Device: Application of a dressing with clorhexidine gluconate in intravascular catheters. |
| "Tegaderm IV" dressing | Active comparator | Use of tegaderm iv dressings for intravascular catheters. Change each 7 days. Receives: Device: Application of a dressing without clorhexidine gluconate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of intravascular central catheter colonization.
Measured: November 2012- March 2013
Secondary outcomes (1)
Adverse effects of CHG Tegaderm ® dressings.
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startSep 2012
- Primary completionMar 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intravascular Catheter ColonizationStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 398 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Central de la Defensa Gómez Ulla
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ANA ISABEL LÓPEZ FIGUERAS, Hospital Central de la Defensa Gómez Ulla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733940
- Sponsor's protocol ID
- 10/12
- Acronym
- EAC-UCI
- Status last verified
- Nov 2012
- First submitted
- 21 Nov 2012
- Last updated
- 28 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tegaderm-CHG® Dressing vs. Tegaderm-IV® Dressing in the Reduction of Central Catheter Colonization in Patients of the Intensive Care Unit of the University "Gómez Ulla" Hospital.
- ClinicalTrials.gov ID
- NCT01733940
- Acronym / sponsor ID
- EAC-UCI / 10/12
- Conditions
- Intravascular Catheter Colonization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 398 participants (estimated)
- Lead sponsor
- Hospital Central de la Defensa Gómez UllaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 27 Nov 2012 (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.
Introduction: The vascular catheter-related bacteremia (BRC) is a major health problem in intensive care units. The use of dressings containing chlorhexidine gluconate (CHG) can decrease the catheters colonization, closely related to infection thereof.
Objective: To determine the efficacy of the dressing "Tegaderm CHG" dressings versus "Tegaderm IV" dressings in reducing the risk of colonization of central intravascular catheters in the intensive care unit (ICU).
Methods: Randomized controlled trial with blinding professional who reviews the main outcome. The study included patients over 18 years, indicating the central intravascular catheter implantation in the ICU or in the operating room, prior informed consent. Excluding subjects with positive blood culture at the time of catheter implantation.
The estimated sample size is 398 patients, with a confidence level of 95% and a statistical power of 80%. The study protocol was approved by the ethics committee of the hospital.
Be made prospectively followed subjects from study entry until catheter removal collecting information on age, sex, APACHEII, antibiotic therapy, duration of catheter insertion site and removal, reason for withdrawal and microbiological information.
For statistical analysis, a model is adjusted multivariate logistic regression, determining the interaction of variables with the likelihood ratio test and confusion by switching between the crude and adjusted effect greater than 10%.
Results and conclusions: The recruitment has started in November 2012 and is scheduled for completion in March 2013. This study will determine whether these new dressings are effective in our environment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| "Tegaderm CHG" Dressing | Experimental | Device: Application of a dressing with clorhexidine gluconate in intravascular catheters.This arm is receiving a clorhexidine dressing for intravascular catheters. |
| "Tegaderm IV" dressing | Active comparator | Device: Application of a dressing without clorhexidine gluconateUse of tegaderm iv dressings for intravascular catheters. Change each 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Application of a dressing with clorhexidine gluconate in intravascular catheters. | Device | "Tegaderm CHG" Dressing |
| Application of a dressing without clorhexidine gluconate | Device | "Tegaderm IV" dressing |
Primary outcome
Incidence of intravascular central catheter colonization.
Time frame: November 2012- March 2013
1 secondary outcome
Adverse effects of CHG Tegaderm ® dressings.
Time frame: up to 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2012.
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.
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 Application of a dressing with clorhexidine gluconate in intravascular catheters. and Application of a dressing without clorhexidine gluconate in people with Intravascular Catheter Colonization, run by Hospital Central de la Defensa Gómez Ulla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 28 Nov 2012. 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 Spain. 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 ana isabel lopez figueras, MD (0034911586958 ext. 22958, alopfi1@oc.mde.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of intravascular central catheter colonization. (time frame: November 2012- March 2013). 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 28 Nov 2012.