NCT01496352

DFA-02 in Patients Undergoing Colorectal Surgery

A Randomized, Double-blind, Placebo Controlled, Safety, Tolerability, and Pharmacokinetic Dose Escalation Study of DFA-02 in Patients Undergoing Colorectal Surgery

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Despite antibiotic prophylaxis and improvements in surgical techniques, surgical site infections (SSI) still occur. DFA-02 is a novel bioresorbable modified release gel containing both gentamicin and vancomycin to be applied during surgical incision closure for the prevention of surgical site infections (SSIs) in patients undergoing colorectal surgery.

Conditions

• Surgical Site Infection

Interventions

Type	Name	Description
DRUG	DFA-02	Modified release product containing gentamicin and vancomycin for application at the conclusion of surgery after closure of the fascia and prior to skin closure
DRUG	Placebo	DFA-02 placebo

Timeline

• Start date: 2012-02-01
• Primary completion: 2013-04-01
• Completion: 2013-06-01
• First posted: 2011-12-21
• Last updated: 2014-09-01
• Results posted: 2014-09-01

Locations

5 sites across 1 country: United States