Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000951257
Ethics application status
Approved
Date submitted
16/10/2009
Date registered
5/11/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Open controlled trial to compare gauze and tape versus polyurethane dressing for central venous access coverage in intensive care patients
Scientific title
Open, controlled, comparative trial to assess bloodstream infection or bacteremia related to catheter when central venous coverage is achieved by gauze and tape versus transparent polyurethane dressing in intensive care patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical care patients 252022 0
bloodstream infection or bacteremia related to catheter 252062 0
Condition category
Condition code
Infection 252215 252215 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The dressings for central venous access will be carried out every seven days, or when necessary, with transparent polyurethane dressing.until discharge from Intensive Care dressing administered by nurse
Intervention code [1] 241424 0
Treatment: Other
Comparator / control treatment
Patients performing daily dressings with gauze and tape for central venous access until discharge from Intensive Care.The patients couldn´t administer the dressings themselves not yet
Control group
Active

Outcomes
Primary outcome [1] 253206 0
culture of bacteria or other microorganisms at head's catheter
Timepoint [1] 253206 0
at seven days after intervention commencement
Secondary outcome [1] 262133 0
Local reaction develpment to the dressing matherial by taking pictures and comparing daily
Timepoint [1] 262133 0
at baseline and at every day after intervention commencement
Secondary outcome [2] 262134 0
Secretion absorption by the dressing matherial at the observation
Timepoint [2] 262134 0
at baseline and at every day after intervention commencement
Secondary outcome [3] 262135 0
dressing material set to the patient?s skin
Timepoint [3] 262135 0
at baseline and at every day after intervention commencement

Eligibility
Key inclusion criteria
patients over 18 years old; hospitalized in Intensive Care Unit ICU; Inclusion in the study within 24 hours of ICU admition or in the first 8 hours after the catheter puncture; patient using central venous catheters, irrespective of indication; authorization to conduct the study through Informed Concent, signed by the family.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients under 18 years; using peripheral venous access only; non-acceptance of their family to participate in this study; patient's intorelance of dressing matherial; dressing of central venous access realized by anyone but the researchers during the observation period; any breach of the research protocol, including a change of technique for dressing making or changing the performer; replacement of the catheter suspected to initiate infection by guidewire.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
21
Accrual to date
Final
Recruitment outside Australia
Country [1] 2269 0
Brazil
State/province [1] 2269 0
Parana

Funding & Sponsors
Funding source category [1] 243892 0
Self funded/Unfunded
Name [1] 243892 0
Country [1] 243892 0
Brazil
Primary sponsor type
Individual
Name
Mitzy Tannia Reichembach Danski
Address
Padre Camargo Street, 120. Curitiba, Paraná, postocode 80060-240.
Country
Brazil
Secondary sponsor category [1] 251329 0
None
Name [1] 251329 0
Address [1] 251329 0
Country [1] 251329 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This study objectified to evaluate the efficiency of gauze and tape and transparent polyurethane film dressings to cover central venous catheters, and for this we compare gauze and tape and transparent polyurethane dressings. Analyzed outcome variables were: 1 - bloodstream infection or bacteremia related to catheter; 2 - dressing material set to the patient’s skin; 3 - secretion absorption by the dressing material; and 4 - local reaction development to the dressing material.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30396 0
Address 30396 0
Country 30396 0
Phone 30396 0
Fax 30396 0
Email 30396 0
Contact person for public queries
Name 13643 0
Mitzy Tannia Reichembach Danski
Address 13643 0
Padre Camargo Street, 120. Curitiba, Parana. Postcode 80060-240.
Country 13643 0
Brazil
Phone 13643 0
+5541 3360 7252
Fax 13643 0
Email 13643 0
profa.mitzy@ufpr.br
Contact person for scientific queries
Name 4571 0
Mitzy Tannia Reichembach Danski
Address 4571 0
Padre Camargo Street, 120. Curitiba, Parana. Postcode 80060-240. Federal University of Parana.
Country 4571 0
Brazil
Phone 4571 0
+5541 3360 7252
Fax 4571 0
Email 4571 0
profa.mitzy@ufpr.br

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.