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

NCT01124578 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2010-05-17

No results posted yet for this study

Summary

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.

Conditions

  • Suction Catheter Bioburder Level After Patient Use.

Sponsors & Collaborators

  • Egret Medical Products Inc.

    lead INDUSTRY

Principal Investigators

  • David Barton, BA, RRT, RCP · Medical City Hospital, Dallas, TX

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-12-31
Completion
2010-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01124578 on ClinicalTrials.gov