Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery
Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
Participant gender:
Summary
This is a randomized, blinded, placebo and standard of care controlled study of the efficacy
of a novel antibiotic containing gel compared to placebo gel in preventing surgical site
infection after abdominal surgery. patients will be randomized to active or placebo gel in a
double-blind manner. The gel will be applied a single time in the incision during closure at
the end of surgery. A cohort of patients will also be randomized to standard of care, saline
irrigation at prior to skin closure, in an open manner. The efficacy, safety and tolerability
of the active gel will be assessed compared to the control group (combined placebo gel and
standard of care groups). Patients will be randomized to DFA-02 active gel: placebo gel:
standard of care in a 4:1:1 ratio.