Clinical trial NCT02324868: Impact of Availability of Showerpatch for Patients With Intravenous Catheters
Official title: Comparison of Showerpatch Versus Other Measures to Protect Intravenous Catheter Entry Site During Bathing Activities
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cystic Fibrosis
Pulmonary Hypertension
Neoplasms
Keywords: Bandages
Catheter
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
Collaborators: name: BEDAL
name: Remedus
First posted: 2014-12-24
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Self-reported autonomy score regarding bathing activities
timeFrame: Weekly until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
Secondary outcomes:
measure: Number and type of bathing activities
timeFrame: Weekly reported, until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
measure: Catheter dressing status: wet
timeFrame: Before and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
measure: Catheter dressing status: loose
timeFrame: Before and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
measure: Time needed from a caregiver
timeFrame: Weekly reported, until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
measure: Material consumption regarding IV entry site care for bathing activities
timeFrame: Weekly reported, until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
measure: Clinical signs of local infection
timeFrame: Before and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
measure: Laboratory-Confirmed Bloodstream Infection
timeFrame: Until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
Other outcomes:
measure: Skin irritation after application of Showerpatch
timeFrame: Before and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
measure: Catheter/Huber needle status
timeFrame: Before and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Godelieve A Goossens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee. Guidelines for the prevention of intravascular catheter-related infections. Am J Infect Control. 2011 May;39(4 Suppl 1):S1-34. doi: 10.1016/j.ajic.2011.01.003. No abstract available.
citation: Oakley C, Wright E, Ream E. The experiences of patients and nurses with a nurse-led peripherally inserted central venous catheter line service. Eur J Oncol Nurs. 2000 Dec;4(4):207-18. doi: 10.1054/ejon.2000.0099.
citation: Molloy D, Smith LN, Aitchison T. Cytotoxic chemotherapy for incurable colorectal cancer: living with a PICC-line. J Clin Nurs. 2008 Sep;17(18):2398-407. doi: 10.1111/j.1365-2702.2008.02359.x.
citation: Do AN, Ray BJ, Banerjee SN, Illian AF, Barnett BJ, Pham MH, Hendricks KA, Jarvis WR. Bloodstream infection associated with needleless device use and the importance of infection-control practices in the home health care setting. J Infect Dis. 1999 Feb;179(2):442-8. doi: 10.1086/314592.