BurnsNCT00136097
Study on the Infection Risk of Long Dwell Period Catheters in High Risk Intensive Care Unit (ICU) Patients
A study testing Placement of a silver impregnated central venous catheter in people with Burns, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
This is an evaluation of the use of silver impregnated catheters in burn patients to reduce catheter colonisation compared to the standard central venous catheter without antiseptic activity. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burns
- What is being tested?
- Placement of a silver impregnated central venous catheter
- Type of treatment
- Medical device
- How many people
- 142 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2005to Jun 2006
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Burn patient
- Placement of a new trilumen central venous catheter
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Infection Risk of Long Dwell Period Catheters in High Risk ICU Patients
This is an evaluation of the use of silver impregnated catheters in burn patients to reduce catheter colonisation compared to the standard central venous catheter without antiseptic activity.
- Conditions
- Burns
- Being tested
- Placement of a silver impregnated central venous catheter
- Keywords
- colonisation of the catheter
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placement of a silver impregnated central venous catheterDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of colonisation of the central venous catheter at the moment of removal
Secondary outcomes (1)
Incidence of a catheter related blood stream infection during the presence of the catheter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2005 (estimated)
- Study startAug 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 142 participants
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Investigators
- Kirsten Colpaert, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136097
- Sponsor's protocol ID
- 2004/266
- Status last verified
- Dec 2007
- First submitted
- 25 Aug 2005
- Last updated
- 28 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Infection Risk of Long Dwell Period Catheters in High Risk ICU Patients
- ClinicalTrials.gov ID
- NCT00136097
- Acronym / sponsor ID
- 2004/266
- Conditions
- Burns
- Keywords
- colonisation of the catheter
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 142 participants
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Aug 2005
- Study completion
- Jun 2006 (actual)
- First posted
- 26 Aug 2005 (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 is an evaluation of the use of silver impregnated catheters in burn patients to reduce catheter colonisation compared to the standard central venous catheter without antiseptic activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Burn patient
- Placement of a new trilumen central venous catheter
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Placement of a silver impregnated central venous catheter | Device | – |
Primary outcome
Degree of colonisation of the central venous catheter at the moment of removal
1 secondary outcome
Incidence of a catheter related blood stream infection during the presence of the catheter
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2007.
- Website University Hospital GhentLink provided by the sponsor.
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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.
Kirsten Colpaert, MD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Placement of a silver impregnated central venous catheter in people with Burns, run by University Hospital, Ghent at 1 site in Belgium.
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 2 inclusion and 0 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: stopped early, as of the sponsor's last update on 28 Dec 2007. 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 Belgium. 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?
The study was stopped early. 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?
Degree of colonisation of the central venous catheter at the moment of removal. 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 Dec 2007.