An interventional study of Standard of Care and DLC Group in Critical Illness, Burns and Surgery, sponsored by Potrero Medical. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-29.
Sponsored by Potrero Medical · Not applicable, Interventional, and Prevention
Catheter-associated urinary tract infections (CAUTI) are the most common nosocomial infections in critically ill patients and are responsible for high morbidity rates, increased hospital stays and associated costs.
The purpose of this study is to evaluate whether active drain line clearance by the Accuryn Monitoring System reduces the incidence of CAUTI in hospitalized patients requiring catheters.
Urinary tract infection (UTI) is the most common healthcare associated infection (HAI) acquired in hospitals and is estimated to account for approximately 13% of hospital infections in the United States, of which 75% are associated with indwelling urinary catheters. It is estimated that between 12-16% adult inpatients will receive an indwelling urinary catheter during their hospital stay. The rate of catheter-associated UTI (CAUTI) are highest in burn ICUs, followed by inpatient medical wards and neurosurgical ICUs.
The purpose of this study is to evaluate whether active drain line clearance by the Accuryn Monitoring System reduces the incidence of bacteriuria and/or CAUTI in patients requiring catheters for more than 72 hours. This study will also evaluate the efficacy in reducing bacteriuria of the Accuryn silver fabricated silicone catheters.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
Browse Burns studies →Potrero Medical is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Compared within Burns, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Critical Illness. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive Standard of Care, commercially available catheter utilized by hospital system.
Device: Standard of Care
Patients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and plain silicone catheter.
Device: DLC Group
Patients will receive FDA-approved Accuryn Monitoring System with active drain line clearance and silver-doped silicone catheter.
Device: DLCS Group
Standard of care urinary drainage system.
Urinary drainage system with active drain line clearance and plain silicone catheter.
Urinary drainage system with active drain line clearance and silver-doped silicone catheter.
Difference in percentage of catheter-associated bacteriuria
To study the difference in rate of catheter-associated bacteriuria between SOC catheters and Accuryn silicone or Accuryn silver-doped catheters with active drain line clearance.
Time frame: 30 days
Percentage of asymptomatic (ASB) and symptomatic (CAUTI) bacteriuria
To study the incidence and progression of asymptomatic bacteriuria and CAUTI in patients with prolonged foley catheters for greater than 72 hours.
Time frame: 30 days
Time to Bacteriuria (ASB and CAUTI)
To study the progression of asymptomatic bacteriuria and CAUTI in patients with prolonged foley catheters for greater than 72 hours.
Time frame: 30 days
Urine Culture Comparisons
To study the correlation between patient urine cultures and cultures taken from the Foley (Foley tip, urine sampled from collection bag).
Time frame: 30 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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