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| ID | Type | Description | Link |
|---|---|---|---|
| FC13145773 | Other Grant/Funding Number | Flander's care |
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logistic problems
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| Name | Class |
|---|---|
| BEDAL | UNKNOWN |
| Remedus | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shower patch IV catheter protection | Experimental | Newly developed waterproof catheter dressing may be used for bathing activities |
|
| Conventional IV catheter protection | Other | No specific dressing will be provided to the patient to protect the catheter entry site during bathing activities. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shower patch IV catheter protection | Device | Shower patch will be available for the patient for bathing activities |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Catheter dressing status: wet |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Godelieve A Goossens, PhD | Universitaire Ziekenhuizen KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21511081 | Background | 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. | |
| 12849017 |
| Label | URL |
|---|---|
| Definition of Laboratory-Confirmed Bloodstream Infection (LCBI) infection | View source |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| D006976 | Hypertension, Pulmonary |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Conventional IV catheter protection | Device | No Shower patch will be provided during study period |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| 18705719 | 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. |
| 9878029 | 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. |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |