Impact of Availability of Showerpatch for Patients With Intravenous Catheters (ISIC)

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

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.

Study Overview

• Status: Terminated
• Conditions: Neoplasms; Cystic Fibrosis; Pulmonary Hypertension
• Intervention / Treatment: Device: Shower patch IV catheter protection; Device: Conventional IV catheter protection

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • University Hospitals Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

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; Shower patch will be available for the patient for bathing activities
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; No Shower patch will be provided during study period

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin irritation after application of Showerpatch	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	Before and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
Catheter/Huber needle status	Expressed on a 3-point scale from 0 which means correct in place to 2 totally removed	Before and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: BEDAL; Remedus
• Investigators: Principal Investigator: Godelieve A Goossens, PhD, Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Helpful Links

• Definition of Laboratory-Confirmed Bloodstream Infection (LCBI) infection

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: December 19, 2014
• First Submitted That Met QC Criteria: December 19, 2014
• First Posted (Estimate): December 24, 2014

Study Record Updates

• Last Update Posted (Estimate): March 30, 2016
• Last Update Submitted That Met QC Criteria: March 29, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Catheter; Bandages
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Hypertension; Cystic Fibrosis; Hypertension, Pulmonary
• Other Study ID Numbers: S57372; FC13145773 (Other Grant/Funding Number: Flander's care)