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Effects of a New Antimicrobial Dressing on Wound Healing and Incidence of Sternal Wound Infections

NCT00203541 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1100

Last updated 2007-11-19

No results posted yet for this study

Summary

The primary objective of this pivotal study is to determine if a new antimicrobial dressing, applied to the sternal incisions of cardiac surgical subjects, will demonstrate a decreased cumulative incidence rate(CI) of localized, superficial infections at the sternal incisional site as compared to the control group, regular, non-antimicrobial dressing.

Conditions

  • Surgical Wound Infection

Interventions

DEVICE

TELFA™ A.M.D. Island dressing

Sponsors & Collaborators

  • Tyco Healthcare Group

    lead INDUSTRY

Principal Investigators

  • Katie Kavounis, MPH · Tyco Healthcare/Kendall

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Completion
2006-06-30

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 NCT00203541 on ClinicalTrials.gov