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

Primary Purpose

Cystic Fibrosis, Pulmonary Hypertension, Neoplasms

Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Shower patch IV catheter protection
Conventional IV catheter protection
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cystic Fibrosis focused on measuring Bandages, Catheter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Shower patch IV catheter protection

Conventional IV catheter protection

Arm Description

Newly developed waterproof catheter dressing may be used for bathing activities

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

Outcomes

Primary Outcome Measures

Self-reported autonomy score regarding bathing activities
autonomy regarding bathing activities will be scored on a newly developed autonomy scale on a weekly basis

Secondary Outcome Measures

Number and type of bathing activities
Number and type of bathing activities per week
Catheter dressing status: wet
Expressed on a 3-point scale from 0 which means not wet to 2 totally wet
Catheter dressing status: loose
Expressed on a 3-point scale from 0 which means not loose to 2 totally loose
Time needed from a caregiver
Time expressed in minutes per week
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.
Clinical signs of local infection
Redness, tenderness, warmth, swelling or pus leakage recorded on a yes/no basis
Laboratory-Confirmed Bloodstream Infection
Collected at the end of the study by retrospective analysis of the patient file in case of hospital admission

Full Information

First Posted
December 19, 2014
Last Updated
March 29, 2016
Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
BEDAL, Remedus
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1. Study Identification

Unique Protocol Identification Number
NCT02324868
Brief Title
Impact of Availability of Showerpatch for Patients With Intravenous Catheters
Acronym
ISIC
Official Title
Comparison of Showerpatch Versus Other Measures to Protect Intravenous Catheter Entry Site During Bathing Activities
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Terminated
Why Stopped
logistic problems
Study Start Date
January 2016 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
Collaborators
BEDAL, Remedus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Pulmonary Hypertension, Neoplasms
Keywords
Bandages, Catheter

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Shower patch IV catheter protection
Arm Type
Experimental
Arm Description
Newly developed waterproof catheter dressing may be used for bathing activities
Arm Title
Conventional IV catheter protection
Arm Type
Other
Arm Description
No specific dressing will be provided to the patient to protect the catheter entry site during bathing activities.
Intervention Type
Device
Intervention Name(s)
Shower patch IV catheter protection
Intervention Description
Shower patch will be available for the patient for bathing activities
Intervention Type
Device
Intervention Name(s)
Conventional IV catheter protection
Intervention Description
No Shower patch will be provided during study period
Primary Outcome Measure Information:
Title
Self-reported autonomy score regarding bathing activities
Description
autonomy regarding bathing activities will be scored on a newly developed autonomy scale on a weekly basis
Time Frame
Weekly until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
Secondary Outcome Measure Information:
Title
Number and type of bathing activities
Description
Number and type of bathing activities per week
Time Frame
Weekly reported, until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
Title
Catheter dressing status: wet
Description
Expressed on a 3-point scale from 0 which means not wet to 2 totally wet
Time Frame
Before and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
Title
Catheter dressing status: loose
Description
Expressed on a 3-point scale from 0 which means not loose to 2 totally loose
Time Frame
Before and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
Title
Time needed from a caregiver
Description
Time expressed in minutes per week
Time Frame
Weekly reported, until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
Title
Material consumption regarding IV entry site care for bathing activities
Description
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.
Time Frame
Weekly reported, until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
Title
Clinical signs of local infection
Description
Redness, tenderness, warmth, swelling or pus leakage recorded on a yes/no basis
Time Frame
Before and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
Title
Laboratory-Confirmed Bloodstream Infection
Description
Collected at the end of the study by retrospective analysis of the patient file in case of hospital admission
Time Frame
Until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
Other Pre-specified Outcome Measures:
Title
Skin irritation after application of Showerpatch
Description
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
Time Frame
Before and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
Title
Catheter/Huber needle status
Description
Expressed on a 3-point scale from 0 which means correct in place to 2 totally removed
Time Frame
Before and after bathing activities, reported until catheter removal which is expected on an average after 2 weeks or up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Godelieve A Goossens, PhD
Organizational Affiliation
Universitaire Ziekenhuizen KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
21511081
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.
Results Reference
background
PubMed Identifier
12849017
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.
Results Reference
background
PubMed Identifier
18705719
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.
Results Reference
background
PubMed Identifier
9878029
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.
Results Reference
background
Links:
URL
http://www.cdc.gov/nhsn/PDFs/pscManual/4PSC_CLABScurrent.pdf
Description
Definition of Laboratory-Confirmed Bloodstream Infection (LCBI) infection

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Impact of Availability of Showerpatch for Patients With Intravenous Catheters

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