Cystic Fibrosis, Neoplasms, Pulmonary Hypertension
Conditions
Keywords
Bandages, Catheter
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.
Interventions
DEVICEShower patch IV catheter protection
Shower patch will be available for the patient for bathing activities
DEVICEConventional IV catheter protection
No Shower patch will be provided during study period
Sponsors
BEDAL
Remedus
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported autonomy score regarding bathing activities | Weekly 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
| Measure | Time frame | Description |
|---|---|---|
| Number and type of bathing activities | Weekly 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 |
| Catheter dressing status: wet | Before 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: loose | Before 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 |
| Time needed from a caregiver | Weekly reported, until catheter removal which is expected on an average after 2 weeks or up to 8 weeks | Time expressed in minutes per week |
| Clinical signs of local infection | Before 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 |
| Laboratory-Confirmed Bloodstream Infection | Until 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 |
| Material consumption regarding IV entry site care for bathing activities | Weekly 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Skin irritation after application of Showerpatch | Before and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks | Redness or other sign of skin irritation at the place where adhesive of the new protection dressing had contact with the skin on a yes/no basis |
| Catheter/Huber needle status | Before 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 correct in place to 2 totally removed |
Countries
Belgium
Outcome results
None listed