- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04462861
A New Securement Method for External Tunneled Central Venous Access Devices (CVAD)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jenny Stevens, MD
- Phone Number: 2515899950
- Email: jenny.stevens@childrenscolorado.org
Study Contact Backup
- Name: Marina Reppucci, MD
- Phone Number: 2037314914
- Email: marina.reppucci@childrenscolorado.org
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 54008
- Recruiting
- Children's Hospital Colorado
-
Contact:
- Marina Reppucci, MD
- Phone Number: 203-731-4914
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CVAD securement device
Patients with a pre-existing CVAD who will trial the new securement dressing
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comfort
Time Frame: 3 weeks
|
Survey question asking for qualitative description of satisfaction
|
3 weeks
|
quality of materials
Time Frame: 3 weeks
|
Survey question asking for qualitative description of satisfaction
|
3 weeks
|
Quality of Adhesive
Time Frame: 3 weeks
|
Survey question asking for qualitative description of satisfaction
|
3 weeks
|
Ease of use
Time Frame: 3 weeks
|
Survey question asking for qualitative description of satisfaction
|
3 weeks
|
Skin irritation
Time Frame: 3 weeks
|
Survey question asking for qualitative description of complication, if applicable
|
3 weeks
|
Infection
Time Frame: 3 weeks
|
Survey question asking for qualitative description of complication, if applicable
|
3 weeks
|
dislodgement
Time Frame: 3 weeks
|
Survey question asking for qualitative description of complication, if applicable
|
3 weeks
|
catheter breakage
Time Frame: 3 weeks
|
Survey question asking for qualitative description of complication, if applicable
|
3 weeks
|
types and numbers of interactions with healthcare providers
Time Frame: 3 weeks
|
Survey question asking for qualitative description of interaction, if applicable
|
3 weeks
|
Perceived safety
Time Frame: 3 weeks
|
Survey question asking for qualitative description of perceived device safety
|
3 weeks
|
overall impression
Time Frame: 3 weeks
|
Survey question asking for qualitative description of overall impression of device
|
3 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Steven L Moulton, MD, Children's Hospital Colorado
Publications and helpful links
General Publications
- Ullman AJ, Marsh N, Mihala G, Cooke M, Rickard CM. Complications of Central Venous Access Devices: A Systematic Review. Pediatrics. 2015 Nov;136(5):e1331-44. doi: 10.1542/peds.2015-1507. Epub 2015 Oct 12.
- Chambers ST, Sanders J, Patton WN, Ganly P, Birch M, Crump JA, Spearing RL. Reduction of exit-site infections of tunnelled intravascular catheters among neutropenic patients by sustained-release chlorhexidine dressings: results from a prospective randomized controlled trial. J Hosp Infect. 2005 Sep;61(1):53-61. doi: 10.1016/j.jhin.2005.01.023.
- Shivnan JC, McGuire D, Freedman S, Sharkazy E, Bosserman G, Larson E, Grouleff P. A comparison of transparent adherent and dry sterile gauze dressings for long-term central catheters in patients undergoing bone marrow transplant. Oncol Nurs Forum. 1991 Nov-Dec;18(8):1349-56.
- Ullman AJ, Cooke M, Rickard C. Examining the role of securement and dressing products to prevent central venous access device failure: a narrative review J Assoc Vasc Access 2015; 20:99-110
- Frey AM, Schears GJ. Why are we stuck on tape and suture? A review of catheter securement devices. J Infus Nurs. 2006 Jan-Feb;29(1):34-8. doi: 10.1097/00129804-200601000-00007.
- Orgel E, Ji L, Pastor W, Schore RJ. Infectious morbidity by catheter type in neutropenic children with cancer. Pediatr Infect Dis J. 2014 Mar;33(3):263-6. doi: 10.1097/INF.0000000000000060.
- Brandt B, DePalma J, Irwin M, Shogan J, Lucke JF. Comparison of central venous catheter dressings in bone marrow transplant recipients. Oncol Nurs Forum. 1996 Jun;23(5):829-36.
- Ruschulte H, Franke M, Gastmeier P, Zenz S, Mahr KH, Buchholz S, Hertenstein B, Hecker H, Piepenbrock S. Prevention of central venous catheter related infections with chlorhexidine gluconate impregnated wound dressings: a randomized controlled trial. Ann Hematol. 2009 Mar;88(3):267-72. doi: 10.1007/s00277-008-0568-7. Epub 2008 Aug 5.
- Ullman AJ, Kleidon T, Gibson V, McBride CA, Mihala G, Cooke M, Rickard CM. Innovative dressing and securement of tunneled central venous access devices in pediatrics: a pilot randomized controlled trial. BMC Cancer. 2017 Aug 30;17(1):595. doi: 10.1186/s12885-017-3606-9.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-1592
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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