NCT01888367

Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery

A Randomized, Blinded, Placebo and Standard of Care Controlled Efficacy, Safety, and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 445 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Surgical Site Infections

Interventions

Type	Name	Description
DRUG	DFA-02 Antibiotic Gel
DRUG	DFA-02 Placebo Gel

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2013-06-27
• Last updated: 2016-10-11
• Results posted: 2016-10-11

Locations

31 sites across 1 country: United States