Impact of Availability of Showerpatch for Patients With Intravenous Catheters

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Showerpatch Versus Other Measures to Protect Intravenous Catheter Entry Site During Bathing Activities

Conditions
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Cystic Fibrosis, Pulmonary Hypertension, Neoplasms

Intervention / Treatment
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* Device: Shower patch IV catheter protection
* Device: Conventional IV catheter protection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: able to read and speak Dutch and to fill out a web-based questionnaire patients with an IV catheter (peripheral catheter, midline, peripherally inserted central catheter (PICC), Central Venous catheter (CVC), tunnelled catheter or implantable port) with an expected dwell time IV therapy of at least 14 days and with or without a prospect of discharge to the home setting with the IV catheter in situ in the foreseen study period physically able to wash themselves with access to the internet Exclusion Criteria: Bedridden patients Patients who have already participated in an earlier stage of the ISIC study Patients with more than one lumen of the catheter continuously connected to an infusion line

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shower patch IV catheter protection<br>Newly developed waterproof catheter dressing may be used for bathing activities | Device: Shower patch IV catheter protection<br>* Shower patch will be available for the patient for bathing activities<br>|
| Other: Conventional IV catheter protection<br>No specific dressing will be provided to the patient to protect the catheter entry site during bathing activities. | Device: Conventional IV catheter protection<br>* No Shower patch will be provided during study period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bandages, Catheter