Impact of Availability of Showerpatch for Patients With Intravenous Catheters

NCT ID: NCT02324868

Last Updated: 2016-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cystic Fibrosis Pulmonary Hypertension Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Shower patch IV catheter protection

Newly developed waterproof catheter dressing may be used for bathing activities

Group Type EXPERIMENTAL

Shower patch IV catheter protection

Intervention Type DEVICE

Shower patch will be available for the patient for bathing activities

Conventional IV catheter protection

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

Group Type OTHER

Conventional IV catheter protection

Intervention Type DEVICE

No Shower patch will be provided during study period

Interventions

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Shower patch IV catheter protection

Shower patch will be available for the patient for bathing activities

Intervention Type DEVICE

Conventional IV catheter protection

No Shower patch will be provided during study period

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BEDAL

UNKNOWN

Sponsor Role collaborator

Remedus

UNKNOWN

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Godelieve A Goossens, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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University Hospitals Leuven

Leuven, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 21511081 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12849017 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18705719 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9878029 (View on PubMed)

Related Links

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http://www.cdc.gov/nhsn/PDFs/pscManual/4PSC_CLABScurrent.pdf

Definition of Laboratory-Confirmed Bloodstream Infection (LCBI) infection

Other Identifiers

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FC13145773

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

S57372

Identifier Type: -

Identifier Source: org_study_id

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