CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,502 enrolled
Drug / intervention
gentamicin-collagen sponge dipped in salinedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00600483
NCT00600483Phase 3Completed
CompareCT.gov

A Randomized, Controlled, Phase 3 Study of Gentamicin-Collagen Sponge in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection

Innocoll·interventional·Posted Jan 25, 2008·Updated May 5, 2022

In Brief

A Phase 3 clinical trial evaluating gentamicin-collagen sponge dipped in saline for Cardiac Surgery and Sternal Wound Infection. Completed, enrolled 1,502 participants across 43 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Surgery, Sternal Wound Infection
CountriesUnited States
CollaboratorsDuke University, Premier Research

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 25, 2008
Enrollment StartDec 1, 2007
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 18.4 years ago

Interventions

gentamicin-collagen sponge dipped in salinedrug

100-cm2 sponge