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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 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

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,729 Previous Clinical Trials
2,143,672 Total Patients Enrolled
Children's Hospital ColoradoOTHER
114 Previous Clinical Trials
5,127,515 Total Patients Enrolled
Steven L Moulton, MDPrincipal InvestigatorChildren's Hospital Colorado
2 Previous Clinical Trials
316 Total Patients Enrolled

Media Library

Central venous access device (CVAD) Snuggie Securement Device Clinical Trial Eligibility Overview. Trial Name: NCT04462861 — N/A
Central Line Infection Research Study Groups: CVAD securement device
Central Line Infection Clinical Trial 2023: Central venous access device (CVAD) Snuggie Securement Device Highlights & Side Effects. Trial Name: NCT04462861 — N/A
Central venous access device (CVAD) Snuggie Securement Device 2023 Treatment Timeline for Medical Study. Trial Name: NCT04462861 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for participants in this medical experiment?

"Affirmative. Clinicaltrial.gov reflects that, as of May 16th 2022, this clinical trial is still actively recruiting participants from one medical centre and the total required sample size is 20 patients. The data was initially posted on October 19th 2020."

Answered by AI

Does this research endeavor include elderly individuals in its cohort?

"This clinical trial dictates that the absolute minimum age for participation is 31 Days, while the uppermost limit of eligibility is 18 years."

Answered by AI

How many research participants are being monitored in this experiment?

"Affirmative. Records on clinicaltrials.gov demonstrate that this medical experiment, which was originally published on October 19th 2020, is still in the process of recruiting participants. Approximately 20 patients are being sought from 1 site to take part in the trial."

Answered by AI

Are there any eligibility requirements for participating in this clinical investigation?

"This clinical trial seeks 20 participants between infancy and young adulthood who are suffering from communicable illnesses. Eligible patients must: be aged 31 days to 18 years, require surgical placement of a tunneled CVAD, have existing CVADs that were not necessitated by the medical condition in question, or present with complications associated with their pre-existing CVAD."

Answered by AI
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~1 spots leftby Jun 2024