What side effects are associated with this type of intervention?

The most common treatments for central line infections include the use of antimicrobial lock solutions and standard care practices such as transparent film dressings. Antimicrobial lock solutions, which can be antibiotic or non-antibiotic, are used to prevent catheter-related infections. Known side effects of these treatments can include local irritation, allergic reactions, and the potential for developing antibiotic resistance. Transparent film dressings, while generally safe, can sometimes cause skin irritation or allergic reactions. Additionally, improper securement can lead to catheter dislodgement or infection, which the new securement method aims to reduce.

What prior FDA approvals exist?

The FDA has approved several antibiotics for the treatment of central line infections, including vancomycin, linezolid, and daptomycin, which are effective against common pathogens like Staphylococcus aureus. Additionally, securement devices and antimicrobial dressings have been developed to reduce the risk of infection. These include chlorhexidine-impregnated dressings and advanced securement devices designed to minimize catheter movement and contamination. The ongoing trial for a new securement method for CVADs aims to further reduce complications such as infections, which aligns with the FDA's focus on improving patient outcomes through better device management and infection control.

What other types of research exist?

Promising alternatives to the new securement method for CVADs include antimicrobial-impregnated catheters, advanced antimicrobial dressings, and technologies like chlorhexidine-impregnated sponges. These innovations aim to reduce infection rates and improve patient outcomes by providing additional antimicrobial protection and better securement.

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CVAD Securement Method for Catheter-related Bloodstream Infections

N/A

Recruiting

Led By Steven L Moulton, MD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 weeks

Awards & highlights

Study Summary

This trial will compare a new, securement method for external tunneled CVADs to the current standard of care. The primary outcome measures will be CVAD-related complications and patient/parent satisfaction.

Who is the study for?

This trial is for children and teens aged 1 month to 18 years who are getting or already have a tunneled CVAD due to serious conditions like cancer. It's not for those whose parents can't consent, prisoners, pregnant women, or individuals unable to make decisions.Check my eligibility

What is being tested?

The study tests a new way of securing CVADs called the Snuggie Securement Device against the usual clear dressing. The goal is to see if it's easier to use, more comfortable, reduces infections and dislodgements, and improves life quality.See study design

What are the potential side effects?

While specific side effects aren't listed for the securement device itself, risks may include skin irritation at the site of application or an allergic reaction to materials in the Snuggie Securement Device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 31 days and 18 years old and will have surgery for a central venous access device.

Select...

I have a central venous access device (CVAD) and am experiencing complications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Comfort

Ease of use

Infection

+8 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: CVAD securement deviceExperimental Treatment1 Intervention

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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Central Line Infections (CLIs) include antimicrobial therapy and improved securement methods. Antimicrobial therapy targets and eradicates the bacterial pathogens responsible for the infection, often using broad-spectrum antibiotics initially, followed by more targeted antibiotics based on culture results. Improved securement methods, such as the newly designed securement device being studied, aim to reduce catheter-related complications by providing better stability and protection at the catheter exit site. This reduces the risk of catheter dislodgement, delayed healing, and infections. These treatments are crucial for CLI patients as they help maintain the functionality of the central line, reduce morbidity and mortality, and ensure the continuity of essential medical therapies.

Prophylactic antibiotics for preventing gram-positive infections associated with long-term central venous catheters in adults and children receiving treatment for cancer.Ecology of Bloodstream Infections and Temporal Trends of Their Antibiograms with Respect to Source and Duration of Incubation: A 5-Year Retrospective Observational Analysis.Prevention of central venous line associated bloodstream infections in adult intensive care units: A systematic review.