2 Clinical Trials for Various Conditions
The purpose of this study is to assess user satisfaction and the frequency of common central venous catheter insertion complications when using a novel cannulation knife.
An external tunneled central venous access device (CVAD) is a small plastic tube that is tunneled under the skin into a major vein for long-term use (Figure 1). Patients who require a tunneled CVAD are some of the sickest patients we encounter and include oncology, hematology, and gastrointestinal (intestinal failure) patients. These patients are heavily reliant on their tunneled CVAD, which can be a lifeline for long-term administration of chemotherapeutics, IV medications, blood product transfusions, antibiotics, enteral nutrition, blood draws and fluids. Unfortunately, nearly 30% of pediatric external tunneled CVADs fail prior to the completion of treatment. External tunneled CVAD failures lead to unnecessary morbidity and mortality, interruption of medical therapy, and the added costs and risks associated with additional procedural complications. It is hypothesized that a newly designed securement method for external tunneled central venous access devices (CVAD) will reduce catheter-related complications and increase patient, parent and provider satisfaction, compared to the current standard of care, which is a clear transparent film dressing over the catheter exit site. A 20 patient, prospective clinical trial is proposed to address the following specific aims, which will determine if the securement device: 1. Is rated by patients, parents and providers as easy to apply and comfortable for users 2. Reduces CVAD-related complications, such as delayed healing of the tract, catheter-related infections, and episodes of catheter dislodgement 3. Improves the quality of life for patients and their parents 4. Is preferred over the standard, clear transparent dressing alone 5. Requires any design modifications to improve performance and/or comfort of the device