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

NCT04462861 | Unknown

• 1 other identifier: 20-1592
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is rated by patients, parents and providers as easy to apply and comfortable for users
2. 2.Reduces CVAD-related complications, such as delayed healing of the tract, catheter-related infections, and episodes of catheter dislodgement
3. 3.Improves the quality of life for patients and their parents
4. 4.Is preferred over the standard, clear transparent dressing alone
5. 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

Keywords

central venous access device, CVAD

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (1)

CVAD securement device

EXPERIMENTAL

Patients with a pre-existing CVAD who will trial the new securement dressing

Device: Central venous access device (CVAD) Snuggie Securement Device

Interventions

Central venous access device (CVAD) Snuggie Securement Device 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

CVAD securement device

Eligibility Criteria

• Age: 31 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Children's Hospital Colorado: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 54008, United States

RECRUITING

Related Publications (9)

• 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.

  PMID: 26459655 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 16428999 BACKGROUND

• 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.

  PMID: 24263218 BACKGROUND

• 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.

  PMID: 8792352 BACKGROUND

• 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.

  PMID: 1762975 BACKGROUND

• 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.

  PMID: 16002181 BACKGROUND

• 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.

  PMID: 18679683 BACKGROUND

• 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.

  PMID: 28854967 BACKGROUND

Study Officials

• Steven L Moulton, MD

  Children's Hospital Colorado

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenny Stevens, MD

CONTACT

2515899950; jenny.stevens@childrenscolorado.org

Marina Reppucci, MD

CONTACT

2037314914; marina.reppucci@childrenscolorado.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 8, 2020
• Study Start: October 19, 2020
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)