Dialysis Catheter Caps Case Feasibility Study

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Sterile Catheter Catheter-related Bloodstream Infections Dialysis Dialysis Catheter

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic (Florida)

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Catheter Caps Case (C3)

Device

The nursing team will then assess the participant's catheter, catheter site, and lumens. The C3 device will be placed on the distal lumens and hub caps of the participant's hemodialysis catheter using clean technique and left in place for approximately 15 minutes. During this time, the participant will be asked to lay, sit, and stand while wearing the C3 device. The RN will stay with the participant during the entire time and will write down any comments or requests regarding the C3 made by the participant. After 15 minutes, the nursing team will remove the C3 device and reassess the condition of the catheter site and lumens, noting any changes. Finally, the participant will complete a 10 item post- intervention survey, developed by the study team and evaluated for face validity by all members of the team to provide feedback on the design of the C3 device.

Primary outcomes

To evaluate the ease and structural integrity of the Catheter Caps Case (C3)

Time frame: 1 Day

The feasibility of the catheter cap will be assessed by evaluating its ease of use and structural integrity. This includes measuring the time required for secure placement and removal compared to traditional gauze and tape, as well as obtaining standardized usability ratings from healthcare providers. Additionally, the study will track the incidence of accidental catheter dislodgement during routine cap changes to determine whether the cap provides enhanced stability.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Apr 1, 2025
Registry last updated: Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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