Study the Average Aerobic Bioburden Levels on Catheters After Use With Egret Catheter and the Predicate Device

Completed

Conditions studied: Suction Catheter Bioburder Level After Patient Use.

In brief

PURPOSE OF EVALUATION: This study will verify \& validate the acceptability of Egret's extended use product as compared to the existing daily change-out product. Based on an extensive in-vitro study, Egret's product confirmed significant kill for both positive and negative gram bacteria. In addition to meeting all of the current product requirements, total aerobic bio-burden on the catheters will be tested at various intervals for up to 10 days of use. The current used product will be used as a control group that is to be changed out daily as per current policy. The control group will be tested for total aerobic bacteria counts on the last day of use.

Key facts

Study ID

NCT01124578

Run by

Egret Medical Products Inc.

People needed

200

Starts

2008-05-01

Expected to finish

2010-03-01

Last updated by the study team

2010-05-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients who agree to consent.

You may not qualify if…

• Patients who do not agree to consent or with confirmed Ventilator-associated Pneumonia (VAP)are to be excluded from this study.

Where it is running

• Medical City Dallas Hospital — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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