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2016-01
2016-02
2016-03
18
NCT02324868
Universitaire Ziekenhuizen KU Leuven
Universitaire Ziekenhuizen KU Leuven
INTERVENTIONAL
Impact of Availability of Showerpatch for Patients With Intravenous Catheters
Venous catheters are necessary for the treatment of many patients. Showering with a venous catheter is often prohibited due to the infection risk when the insertion site becomes wet. Therefore these patients are challenged to keep the catheter insertion site dry and always covered with a dressing. Washing themselves is often impossible without assistance of a nurse or significant other. For patients with a catheter connected to an infusion line, it is even more difficult. Showerpatch is a newly developed dressing that safeguards the insertion site of an IV catheter from water during bathing activities. The purpose of this trial is to evaluate the impact of the availability of Showerpatch by comparing the outcomes in patients regarding the patient's autonomy in bathing activities, the material use and the time needed from caregivers in home care. Additionally qualitative data on patient's bathing activities and the use of Showerpatch will be collected.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2014-12-19 | N/A | 2016-03-29 |
2014-12-19 | N/A | 2016-03-30 |
2014-12-24 | N/A | 2016-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Supportive Care
Allocation:
Randomized
Interventional Model:
Crossover
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Shower patch IV catheter protection Newly developed waterproof catheter dressing may be used for bathing activities | DEVICE: Shower patch IV catheter protection
|
| OTHER: Conventional IV catheter protection No specific dressing will be provided to the patient to protect the catheter entry site during bathing activities. | DEVICE: Conventional IV catheter protection
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Self-reported autonomy score regarding bathing activities | autonomy regarding bathing activities will be scored on a newly developed autonomy scale on a weekly basis | Weekly until catheter removal which is expected on an average after 2 weeks or up to 8 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Number and type of bathing activities | Number and type of bathing activities per week | Weekly reported, until catheter removal which is expected on an average after 2 weeks or up to 8 weeks |
| Catheter dressing status: wet | Expressed on a 3-point scale from 0 which means not wet to 2 totally wet | Before and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks |
| Catheter dressing status: loose | Expressed on a 3-point scale from 0 which means not loose to 2 totally loose | Before and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks |
| Time needed from a caregiver | Time expressed in minutes per week | Weekly reported, until catheter removal which is expected on an average after 2 weeks or up to 8 weeks |
| Material consumption regarding IV entry site care for bathing activities | Description of material which was used for catheter dressing protection and/or for the extra dressing change and/or extra securement of the dressing afterwards. | Weekly reported, until catheter removal which is expected on an average after 2 weeks or up to 8 weeks |
| Clinical signs of local infection | Redness, tenderness, warmth, swelling or pus leakage recorded on a yes/no basis | Before and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks |
| Laboratory-Confirmed Bloodstream Infection | Collected at the end of the study by retrospective analysis of the patient file in case of hospital admission | Until catheter removal which is expected on an average after 2 weeks or up to 8 weeks |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
