Dialysis Catheter Caps Case Feasibility Study

Mayo Clinic

Status

Active, not recruiting

Conditions

Dialysis Catheter

Dialysis

Sterile Catheter

Catheter-related Bloodstream Infections

Treatments

Device: Catheter Caps Case (C3)

Study type

Interventional

Funder types

Other

Identifiers

NCT06905080

24-010774

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria