Clinical trial NCT06905080: Dialysis Catheter Caps Case Feasibility Study
Official title: Dialysis Catheter Caps Case Feasibility Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Sterile Catheter
Catheter-related Bloodstream Infections
Dialysis Catheter
Dialysis
Keywords: Sterile Catheter
catheter-related bloodstream infections
Catheter Caps Case
infection control
C3
Dialysis Catheter Caps Case
Dialysis Catheter
Dialysis
Catheter
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-04-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this research is to evaluate patient comfort and ease of an investigational device called Catheter Caps Case (C3) attached to the hemodialysis catheter over a 15-minute period. You have been asked to take part in this research because you have been identified as a dialysis patient with a hemodialysis catheter.

Detailed description: Tunneled hemodialysis catheters are commonly used to administer dialysis to patients with kidney failure to remove excess fluid and waste from the blood. Traditionally, the maintenance and protection of these catheters involves the use of gauze and tape to secure the catheter and cover the double lumen and caps. While this method is widely practiced, it has several drawbacks that can affect both patient outcomes and healthcare efficiency.

Firstly, the use of gauze and tape can be uncomfortable for patients. The adhesive nature of the tape can cause skin irritation and allergic reactions, in addition the gauze can impede visualization of the entire length of the catheter. Additionally, the process of routine changing gauze and tape is time-consuming for healthcare providers and can increase the risk of catheter dislodgment during or catheter caps disconnection during removal of tape gauze combination.

Another significant concern is infection control. Gauze and tape do not provide an optimal sterile barrier, which can lead to an increased risk of catheter-related bloodstream infections (CRBSIs). These infections are associated with prolonged hospital stays, higher hospital healthcare costs, and increased patient mobility and mortality.

The catheter caps case was developed to address these issues by providing a more secure and sterile alternative to gauze and tape. The case is designed to cover the catheter's double lumen and end caps, offering added protection and stability. Its innovative design aims to reduce the risk of accidental dislodgement, enhance infection control, and improve overall patient comfort by eliminating the need for gauze and adhesive tape.

Eligibility criteria: Inclusion Criteria:

1. Patients with tunneled dialysis catheter that will not be removed in the next 90 days.
2. Patients from the home dialysis program or in-center (outpatient dialysis) patient population.
3. Patients who are age 18 years or older

Exclusion Criteria:

1. Patient-delayed graft function (DGF)
2. Acute kidney injury patients
3. Patients with non-tunneled catheter
4. Allergies to the BioMed Elastic 50A Resin

Primary outcomes:
measure: To evaluate the ease and structural integrity of the Catheter Caps Case (C3)
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic (Florida)
state: Florida
Study officials:
References: