Impact of Availability of Showerpatch for Patients With Intravenous Catheters

Cystic Fibrosis Clinical Trial

— ISIC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02324868
• Other study ID #: S57372
• Secondary ID: FC13145773
• Status: Terminated
• Phase: N/A
• First received: December 19, 2014
• Last updated: March 29, 2016
• Start date: January 2016
• Est. completion date: March 2016

Study information

• Verified date: January 2016
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cystic Fibrosis
• Hypertension, Pulmonary
• Neoplasms
• Pulmonary Hypertension

Intervention

Device:
• Shower patch IV catheter protection
Shower patch will be available for the patient for bathing activities
• Conventional IV catheter protection
No Shower patch will be provided during study period

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (3)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven	BEDAL, Remedus

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Other	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	Yes
Primary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	Yes

External Links

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