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NCT00600483 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of an Antibiotic Implant in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection

A Phase 3 study of Cardiac Surgery and Sternal Wound Infection, sponsored by Innocoll.

Completed
Registry status
Phase 3
Development phase
1,502
Enrollment target
20
Study locations

NCT00600483 is a Phase 3 study of Cardiac Surgery and Sternal Wound Infection that has completed, run by Innocoll. The registered enrollment target is 1,502 participants, above the 667-participant average among 19 other Cardiac Surgery trials with a reported enrollment target (125% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT00600483, a Phase 3 study of Cardiac Surgery and Sternal Wound Infection, has completed, sponsored by Innocoll.

COMPLETED
Registry status
Phase 3
Development phase
1,502 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective in preventing sternal wound infections in patients undergoing cardiac surgery who are at a greater risk of developing sternal wound infections.

Conditions Studied

Cardiac Surgery Sternal Wound Infection

Interventions

  • DRUG gentamicin-collagen sponge dipped in saline

Study Locations (20)

Florida

  • - Brandon
  • - Jacksonville
  • - Miami

Maryland

  • - Baltimore
  • - Salisbury
  • - Takoma Park

Alabama

  • - Birmingham
  • - Florence

California

  • - Pasadena
  • - San Francisco

Illinois

  • - Maywood
  • - Springfield

Kansas

  • - Olathe
  • - Wichita

Michigan

  • - Bay City
  • - Lansing

Georgia

  • - Augusta

Trial Details

FieldValue
Enrollment Target 1,502 participants
Start Date 2007-12
Est. Completion 2010-09
Phase Phase 3

Sponsor

Innocoll

19 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00600483

The ClinicalTrials.gov registry entry for NCT00600483 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,502 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 667-participant average among 19 other Cardiac Surgery trials with a reported enrollment target (125% higher). The listed sponsor is Innocoll, which has 19 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Cardiac Surgery appearing as the primary indexed condition, and to 1 intervention - of which gentamicin-collagen sponge dipped in saline is the first listed.

NCT00600483 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, Maryland, Alabama.

Frequently Asked Questions

What is clinical trial NCT00600483 about?

NCT00600483 is a clinical study titled "Safety and Efficacy of an Antibiotic Implant in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection". The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective in preventing sternal wound infections in patients undergoing cardiac surgery who are at a greater risk of developing sternal wound infections.

What is the current status of trial NCT00600483?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,502 participants. The study started on 2007-12. Estimated completion is 2010-09.

What conditions does trial NCT00600483 study?

This clinical trial studies the following conditions: Cardiac Surgery, Sternal Wound Infection.

What interventions are being tested in trial NCT00600483?

The interventions under investigation include: gentamicin-collagen sponge dipped in saline (DRUG).

Who is sponsoring clinical trial NCT00600483?

This trial is sponsored by Innocoll, which has 19 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00600483 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.