MedPath

Impact of Availability of Showerpatch for Patients With Intravenous Catheters

Not Applicable
Terminated
Conditions
Pulmonary Hypertension
Neoplasms
Cystic Fibrosis
Interventions
Device: Shower patch IV catheter protection
Device: Conventional IV catheter protection
Registration Number
NCT02324868
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
18
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Shower patch IV catheter protectionShower patch IV catheter protectionNewly developed waterproof catheter dressing may be used for bathing activities
Conventional IV catheter protectionConventional IV catheter protectionNo specific dressing will be provided to the patient to protect the catheter entry site during bathing activities.
Primary Outcome Measures
NameTimeMethod
Self-reported autonomy score regarding bathing activitiesWeekly until catheter removal which is expected on an average after 2 weeks or up to 8 weeks

autonomy regarding bathing activities will be scored on a newly developed autonomy scale on a weekly basis

Secondary Outcome Measures
NameTimeMethod
Time needed from a caregiverWeekly reported, until catheter removal which is expected on an average after 2 weeks or up to 8 weeks

Time expressed in minutes per week

Laboratory-Confirmed Bloodstream InfectionUntil catheter removal which is expected on an average after 2 weeks or up to 8 weeks

Collected at the end of the study by retrospective analysis of the patient file in case of hospital admission

Catheter dressing status: wetBefore and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks

Expressed on a 3-point scale from 0 which means not wet to 2 totally wet

Catheter dressing status: looseBefore and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks

Expressed on a 3-point scale from 0 which means not loose to 2 totally loose

Number and type of bathing activitiesWeekly reported, until catheter removal which is expected on an average after 2 weeks or up to 8 weeks

Number and type of bathing activities per week

Material consumption regarding IV entry site care for bathing activitiesWeekly reported, until catheter removal which is expected on an average after 2 weeks or up to 8 weeks

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.

Clinical signs of local infectionBefore and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks

Redness, tenderness, warmth, swelling or pus leakage recorded on a yes/no basis

Trial Locations

Locations (1)

University Hospitals Leuven

🇧🇪

Leuven, Belgium

© Copyright 2025. All Rights Reserved by MedPath