At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 30 enrolled
Drug / intervention
DFA-02 +1 moredrug
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, Double-blind, Placebo Controlled, Safety, Tolerability, and Pharmacokinetic Dose Escalation Study of DFA-02 in Patients Undergoing Colorectal Surgery
In Brief
A Phase 2 clinical trial evaluating DFA-02 and Placebo for Surgical Site Infection. Completed, enrolled 30 participants across 5 sites.
Detailed Summary
This is a randomized, double-blind, placebo controlled, safety, tolerability, and pharmacokinetic dose escalation Phase II study of DFA-02 in patients undergoing colorectal surgery to evaluate the safety, tolerability and pharmacokinetics of DFA-02.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSurgical Site Infection
CountriesUnited States
CollaboratorsDuke Clinical Research Institute
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 2011
Enrollment StartFeb 2012
Primary CompletionApr 2013
Study CompletionJun 2013
TodayJul 2026
First PostedDec 21, 2011
Enrollment StartFeb 1, 2012
Primary CompletionApr 1, 2013
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.5 years ago
Interventions
DFA-02drug
Modified release product containing gentamicin and vancomycin for application at the conclusion of surgery after closure of the fascia and prior to skin closure
Placebodrug
DFA-02 placebo