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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: Completed Phase 3 study of Cardiac Surgery and Sternal Wound Infection, sponsored by Innocoll.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Efficacy will be evaluated by a comparison between the 2 study groups of the incidence of surgical wound infections that occur within the period from surgery through postop day 90.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,502 participants |
| Start Date | 2007-12 |
| Est. Completion | 2010-09 |
| Phase | Phase 3 |
What the finished NCT00600483 record still lists
NCT00600483 is an interventional study that assigns participants to a tested intervention. Its 1,502 participants enrollment target places it among the larger protocols in the corpus, above the 667-participant average among 19 other Cardiac Surgery trials with a reported enrollment target (125% higher).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
Similar trials for Cardiac Surgery
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00600483's enrollment target sits among peer trials
1,502 3rd of 19 higher than 17 of 19 other Cardiac Surgery trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiac Surgery trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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