Conditions: Surgical Site Infections
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 445
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure. arm 2: Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure. arm 3: Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.

Interventions: intervention 1: DFA-02 Antibiotic Gel intervention 2: DFA-02 Placebo Gel
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: