ChlorhexidinePhase 3Dressing RCTNCT07001527
Dressing Impregnated With Chlorhexidine and Vancomycin for the Prophylaxis of Central Venous Catheter-related Infections - a Randomized Trial
A Phase 3 study testing Chlorhexidine in people with Chlorhexidine, run by Hospital Universitario Evangelico de Curitiba at 1 site in Brazil.
Trial summary
You are being invited as a volunteer to participate in the study "Dressing impregnated with chlorhexidine and vancomycin for the prophylaxis of central venous catheter-related infections." The objective is to evaluate the incidence of bloodstream infection related to the catheter in ICU patients with central venous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chlorhexidine
- What is being tested?
- Chlorhexidine
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 516 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2022to 1 Jun 2023
- Phase
- Phase 3
- 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
IInclusion criteria included: age over 18 years, admitted to the ICU, need for a CVC placed in the ICU by the trained team, use of the CVC for a period exceeding 72 hours, and intact skin in the area of contact with the dressing. CVC inserted outside the ICU and need for two CVCs in the same patient simultaneously were exclusion criteria. A subsequent CVC could not be randomized. Other infections were not excluded during the evaluation. Only short-term CVC were evaluated (long-term and hemodialysis were excluded).
Trial locations and contacts
1 site in 1 country.
About this study
You are being invited as a volunteer to participate in the study "Dressing impregnated with chlorhexidine and vancomycin for the prophylaxis of central venous catheter-related infections." The objective is to evaluate the incidence of bloodstream infection related to the catheter in ICU patients with central venous catheters (CVC), using dressings impregnated or not with chlorhexidine/vancomycin. We believe this study is important as it aims to evaluate a new dressing method intended to reduce bloodstream-related infections.
- Conditions
- Chlorhexidine
- Being tested
- Chlorhexidine
- Keywords
- chlorhexidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlorhexidineDevice
Also called Impregnated dressing
dressing impregnated
ChlorhexidineDevice
Also called COmmon dressing
COmmon dressing
| Study group | Role | What they receive |
|---|---|---|
| Impregnated | Active comparator | Impregnated Receives: Device: Chlorhexidine |
| Control | Placebo comparator | COmmon dressing Receives: Device: Chlorhexidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infection
CRBSI was the primary endpoint
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 Jun 2022
- Primary completion2 Jun 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChlorhexidineStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 516 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Evangelico de Curitiba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Felipe Francisco Bondan Tuon, Pontifícia Universidade Católica do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001527
- Sponsor's protocol ID
- PUCPR-Dressing
- Other IDs
- 0001
- Acronym
- Dressing RCT
- Status last verified
- May 2025
- First submitted
- 23 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dressing Impregnated With Chlorhexidine and Vancomycin for the Prophylaxis of Central Venous Catheter-related Infections - a Randomized Trial
- ClinicalTrials.gov ID
- NCT07001527
- Acronym / sponsor ID
- Dressing RCT / PUCPR-Dressing
- Conditions
- Chlorhexidine
- Keywords
- chlorhexidine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 516 participants (actual)
- Lead sponsor
- Hospital Universitario Evangelico de CuritibaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 2 Jun 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 3 Jun 2025 (actual)
- 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.
You are being invited as a volunteer to participate in the study "Dressing impregnated with chlorhexidine and vancomycin for the prophylaxis of central venous catheter-related infections." The objective is to evaluate the incidence of bloodstream infection related to the catheter in ICU patients with central venous catheters (CVC), using dressings impregnated or not with chlorhexidine/vancomycin. We believe this study is important as it aims to evaluate a new dressing method intended to reduce bloodstream-related infections.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Impregnated | Active comparator | Device: ChlorhexidineImpregnated |
| Control | Placebo comparator | Device: ChlorhexidineCOmmon dressing |
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 |
|---|---|---|
| ChlorhexidineAlso: Impregnated dressingdressing impregnated | Device | Control, Impregnated |
| ChlorhexidineAlso: COmmon dressingCOmmon dressing | Device | Control, Impregnated |
Primary outcome
Infection
Time frame: 30 days
CRBSI was the primary endpoint
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chlorhexidine in people with Chlorhexidine, run by Hospital Universitario Evangelico de Curitiba 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?
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: finished, as of the sponsor's last update on 3 Jun 2025. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Infection (time frame: 30 days). 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 3 Jun 2025.