At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 602 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.
A Randomized, Controlled, Phase 3 Study of Gentamicin-Collagen Sponge in General Surgical Subjects at Higher Risk for Surgical Wound Infection
In Brief
A Phase 3 clinical trial evaluating gentamicin-collagen sponge dipped in saline for Colorectal Surgery and Surgical Wound Infection. Completed, enrolled 602 participants across 39 sites.
Detailed Summary
The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective for preventing surgical wound infections in patients undergoing colorectal surgery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Surgery, Surgical Wound Infection
CountriesUnited States
CollaboratorsDuke University, Premier Research
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2008
First PostedJan 2008
Primary CompletionMar 2009
Study CompletionSep 2010
TodayJul 2026
First PostedJan 25, 2008
Enrollment StartJan 1, 2008
Primary CompletionMar 1, 2009
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.4 years ago
Interventions
gentamicin-collagen sponge dipped in salinedrug
2 gentamicin-collagen sponges inserted before closure of the laparotomy