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

NCT04462861 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-06-15

No results posted yet for this study

Summary

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

Conditions

  • Central Venous Catheter Exit Site Infection
  • Central Venous Catheter Related Bloodstream Infection

Interventions

DEVICE

Central venous access device (CVAD) Snuggie Securement Device

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

Sponsors & Collaborators

  • Children's Hospital Colorado

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Steven L Moulton, MD · Children's Hospital Colorado

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
31 Days
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-19
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04462861 on ClinicalTrials.gov