Primary: Investigate if sterile transparent dressing pasted on the skin before CVC insertion reduces the contamination risk of the CVC.Secondary: Investigate if direct contamination has a clinical significance.Investigate what the mayor…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reduction of 50% of contamination in the intervention group
Secondary outcome
Determine what the percentage of direct contamination after CVC insertion.
Matching of the micro-organism on the skin of the patient; the blood culture;
the glove of the anesthesiologist and the surgeon with the micro-organism on
the catheter tip.
Reduction of catheter related infections (CRI) in the intervention group
compaired with the nonintervention group.
The percentage CRI in the group of patients who were directly contaminated
compaired with the percentage CRI in the group who were not directly
contaminated.
The percentage positive bloodcultures after induction of anesthesia.
Background summary
In intensive care (IC) medicin central venous catheters (CVC) are frequently
used. CVC's are a potential risk for nosocomial infections. CVC's are thus a
major cause of a serious complication on the ICU. These infections are
associated with an overall attributable mortality, morbidity and attributable
costs.
A possible contamination source is direct contamination after insertion.
Although the CVC is inserted under strikt sterile conditions the CVC can be
contaminated directly during insertion. The skin is most likely the
contamination source. The contamination chance could be reduced if the skin is
covered with sterile transparent dressing. With this study we will investigate
if application of a sterile transparent dressing on the skin before CVC
insertion reduces the contamination risk.
Study objective
Primary:
Investigate if sterile transparent dressing pasted on the skin before CVC
insertion reduces the contamination risk of the CVC.
Secondary:
Investigate if direct contamination has a clinical significance.
Investigate what the mayor contamination source is.
Investigate if sterile transparent dressing prevents catheter related infection
(CRI).
Investigate what the relation is beween direct contamination and CRI
Investigate how often the bloodculture is positive after induction.
Study design
Single blind randomised study
Intervention
After randomisation a sterile transparent dressing will be applied on the skin
of one group of the patients before the CVC is inserted.
Study burden and risks
The study implicates that next to the usual central venous catheter (CVC) one
additional CVC will be inserted in the right internal jugular vene. Both CVC's
will be placed under general aneasthesia, the extra CVC will be removed at the
end of the operation. The patient will still be under general aneasthesia.
Insertion of CVC in the internal jugular vene can be complicated by
pneumothorax and perforation of the internal carotis artery. However the
additive risk is negligible because the anaesthesiologist is aware of the exact
location of the internal jugular vene.
Furthermore one extra blood culture (20 ml.) will be done postoperatively.
Two extra bloodsamples will be taken (2 ml. a day).
Cutting of the CVC in situ can also be an additional risk factor. As well as
one of the thoracic surgeons as the manufacturer of the CVC have declaired that
they approve with the study protocol.
Koekoekslaan 1
3435 cm
NL
Koekoekslaan 1
3435 cm
NL
Listed location countries
Age
Inclusion criteria
Cardiac surgery patients in whom the surgery indicates to open the right atrium after starting cardiac pulmonairy bypass
Exclusion criteria
Younger than 18 years
Endocarditis
proven bacterial infection
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL13186.100.06 |