A New Securement Method for External Tunneled Central Venous Access Devices (CVAD)

Study Overview
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Brief Summary
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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: Is rated by patients, parents and providers as easy to apply and comfortable for users Reduces CVAD-related complications, such as delayed healing of the tract, catheter-related infections, and episodes of catheter dislodgement Improves the quality of life for patients and their parents Is preferred over the standard, clear transparent dressing alone Requires any design modifications to improve performance and/or comfort of the device

Detailed Description
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A prospective pilot trial to examine the feasibility for a new CVAD securement device prototype (see appendix for computer-aided design drawings). Eligible patients will be identified by either mid-level providers, consulting services, or attending surgeons. Researchers will obtain consent from the patient or their parent/legal guardian. Caregivers will be educated on how to apply the securement device and will be given a number to call should they have any questions or concerns. Once the patient is enrolled and provided with the device, the investigators will perform follow up telephone interviews at one and three weeks to evaluate their experience and ensure they did not experience any adverse events. The investigators will prospectively record the primary and secondary outcomes regarding use of the securement device, including: comfort, quality of materials, adhesive, ease of use, skin problems, infections, dislodgement episodes, catheter breakage, types and numbers of interactions with healthcare providers (phone calls, emergency department and clinic visits), perceived safety, and overall impressions.

Official Title
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A New Securement Method for External Tunneled Central Venous Access Devices (CVAD)

Conditions
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Central Venous Catheter Exit Site Infection, Central Venous Catheter Related Bloodstream Infection

Intervention / Treatment
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* Device: Central venous access device (CVAD) Snuggie Securement Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 31 days to 18 years old, who will undergo surgical placement of a tunneled CVAD Any patient with a pre-existing CVAD, who presents to the surgery clinic, emergency department, or is seen as an inpatient consult relating to complications associated with their CVAD Patients admitted to the hospital with a pre-existing CVAD for reasons unrelated to the CVAD will be eligible for the study Exclusion Criteria: Any assenting child or consenting parent/guardian can at any time refuse to participate in the study and will be removed Any patient whose parents or legal guardians cannot be reached in person or by telephone to provide consent Any prisoners, pregnant women, or person with impaired decision-making capacity

Ages Eligible for Study
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Minimum Age: 31 Days
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CVAD securement device<br>Patients with a pre-existing CVAD who will trial the new securement dressing | Device: Central venous access device (CVAD) Snuggie Securement Device<br>* Participants will be given a prototype of a CVAD securement device for a three week trial. Descriptive data relating to user satisfaction will be collected at 1 and 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort | Survey question asking for qualitative description of satisfaction | 3 weeks | 
| quality of materials | Survey question asking for qualitative description of satisfaction | 3 weeks | 
| Quality of Adhesive | Survey question asking for qualitative description of satisfaction | 3 weeks | 
| Ease of use | Survey question asking for qualitative description of satisfaction | 3 weeks | 
| Skin irritation | Survey question asking for qualitative description of complication, if applicable | 3 weeks | 
| Infection | Survey question asking for qualitative description of complication, if applicable | 3 weeks | 
| dislodgement | Survey question asking for qualitative description of complication, if applicable | 3 weeks | 
| catheter breakage | Survey question asking for qualitative description of complication, if applicable | 3 weeks | 
| types and numbers of interactions with healthcare providers | Survey question asking for qualitative description of interaction, if applicable | 3 weeks | 
| Perceived safety | Survey question asking for qualitative description of perceived device safety | 3 weeks | 
| overall impression | Survey question asking for qualitative description of overall impression of device | 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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central venous access device, CVAD