Impact of Availability of Showerpatch for Patients With Intravenous Catheters

NCT02324868 | Terminated

• 2 other identifiers: S57372FC13145773
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis; Pulmonary Hypertension; Neoplasms

Keywords

Bandages; Catheter

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• 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

• 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

• Time needed from a caregiver

  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

  Weekly reported, until catheter removal which is expected on an average after 2 weeks or up to 8 weeks

Other Outcomes (2)

• 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

• 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

Study Arms (2)

Shower patch IV catheter protection

EXPERIMENTAL

Newly developed waterproof catheter dressing may be used for bathing activities

Device: Shower patch IV catheter protection

Conventional IV catheter protection

OTHER

No specific dressing will be provided to the patient to protect the catheter entry site during bathing activities.

Device: Conventional IV catheter protection

Interventions

Shower patch IV catheter protection DEVICE

Shower patch will be available for the patient for bathing activities

Shower patch IV catheter protection

Conventional IV catheter protection DEVICE

No Shower patch will be provided during study period

Conventional IV catheter protection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• BEDAL: collaborator
• Remedus: collaborator

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Related Publications (4)

• 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.

  PMID: 21511081 BACKGROUND

• 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.

  PMID: 12849017 BACKGROUND

• 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.

  PMID: 18705719 BACKGROUND

• 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.

  PMID: 9878029 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Cystic Fibrosis; Hypertension, Pulmonary; Neoplasms

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Godelieve A Goossens, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: December 24, 2014
• Study Start: January 1, 2016
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 30, 2016

Record last verified: 2016-01

Locations

BE (1)