Cystic FibrosisISICNCT02324868
Impact of Availability of Showerpatch for Patients With Intravenous Catheters
A study testing Shower patch IV catheter protection and Conventional IV catheter protection in people with Cystic Fibrosis and Pulmonary Hypertension, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis, Pulmonary Hypertension, Neoplasms
- What is being tested?
- Shower patch IV catheter protection and Conventional IV catheter protection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2016to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cystic Fibrosis, Pulmonary Hypertension, Neoplasms
- Being tested
- Shower patch IV catheter protection, Conventional IV catheter protection
- Keywords
- Bandages, Catheter
- Medical subject headings
- Cystic Fibrosis, Hypertension, Pulmonary, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shower patch IV catheter protectionDevice
Shower patch will be available for the patient for bathing activities
Conventional IV catheter protectionDevice
No Shower patch will be provided during study period
| Study group | Role | What they receive |
|---|---|---|
| Shower patch IV catheter protection | Experimental | Newly developed waterproof catheter dressing may be used for bathing activities Receives: 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. Receives: Device: Conventional IV catheter protection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported autonomy score regarding bathing activities
autonomy regarding bathing activities will be scored on a newly developed autonomy scale on a weekly basis
Measured: 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
Number and type of bathing activities per week
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: Until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startJan 2016
- Primary completionFeb 2016
- Study completionMar 2016
Why it stopped: logistic problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- BEDAL, Remedus
- Responsible party
- Sponsor
- Investigators
- Godelieve A Goossens, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324868
- Sponsor's protocol ID
- S57372
- Other IDs
- FC13145773
- Acronym
- ISIC
- Status last verified
- Jan 2016
- First submitted
- 19 Dec 2014
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21511081Oakley 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.
PubMed 12849017Molloy 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.
PubMed 18705719Do 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.
PubMed 9878029
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Showerpatch Versus Other Measures to Protect Intravenous Catheter Entry Site During Bathing Activities
- ClinicalTrials.gov ID
- NCT02324868
- Acronym / sponsor ID
- ISIC / S57372
- Conditions
- Cystic Fibrosis, Pulmonary Hypertension, Neoplasms
- Keywords
- Bandages, Catheter
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: logistic problems
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- BEDAL, Remedus
- Study start
- Jan 2016
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shower patch IV catheter protection | Experimental | Device: Shower patch IV catheter protectionNewly developed waterproof catheter dressing may be used for bathing activities |
| Conventional IV catheter protection | Other | Device: Conventional IV catheter protectionNo specific dressing will be provided to the patient to protect the catheter entry site during bathing activities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shower patch IV catheter protectionShower patch will be available for the patient for bathing activities | Device | Shower patch IV catheter protection |
| Conventional IV catheter protectionNo Shower patch will be provided during study period | Device | Conventional IV catheter protection |
Primary outcome
Self-reported autonomy score regarding bathing activities
Time frame: Weekly until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
autonomy regarding bathing activities will be scored on a newly developed autonomy scale on a weekly basis
7 secondary outcomes
Number and type of bathing activities
Time frame: Weekly reported, until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
Catheter dressing status: 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
Catheter dressing status: 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
Time needed from a caregiver
Time frame: 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
Time frame: Weekly reported, until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
Clinical signs of local infection
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
Laboratory-Confirmed Bloodstream Infection
Time frame: Until catheter removal which is expected on an average after 2 weeks or up to 8 weeks
Results and safety
The study was stopped early (reason given: logistic problems). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2016.
- Background: PubMed 21511081O'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.
- Background: PubMed 12849017Oakley 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.
- Background: PubMed 18705719Molloy 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.
- Background: PubMed 9878029Do 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Godelieve A Goossens, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shower patch IV catheter protection and Conventional IV catheter protection in people with Cystic Fibrosis and Pulmonary Hypertension, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: logistic problems). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported autonomy score regarding bathing activities (time frame: Weekly until catheter removal which is expected on an average after 2 weeks or up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02324868, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2016.