DFA-02 in Patients Undergoing Colorectal Surgery
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 Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-blind, Placebo Controlled, Safety, Tolerability, and Pharmacokinetic Dose Escalation Study of DFA-02 in Patients Undergoing Colorectal Surgery|
- Number of patients with adverse events, laboratory, physical examination changes [ Time Frame: Baseline up to Day 30 ] [ Designated as safety issue: Yes ]Safety and tolerability measured by number of patients with adverse events or changes in laboratory or physical examination findings from baseline (DFA-02 application during surgery on Day 1) to 30 days after surgery.
- Area Under Curve (AUC) [ Time Frame: 1, 6, 24, 48 96 hours post-dose ] [ Designated as safety issue: Yes ]Area under the curve (AUC)of plasma gentamicin and vancomycin levels using sparse sampling from baseline (DFA-02 application during surgery on Day 1) to 4 days after surgery
- Maximal Plasma Concentration (Cmax) [ Time Frame: 1, 6, 24, 48, 96 hours post-dose ] [ Designated as safety issue: Yes ]Maximal plasma concentration (Cmax)of gentamicin and vancomycin using sparse sampling from baseline (DFA-02 application during surgery on Day 1) to 4 days after surgery
- Renal function [ Time Frame: Baseline up to Day 14 ] [ Designated as safety issue: Yes ]Changes in serum creatinine from surgery on Day 1 until 14 days after surgery
- Antibiotic resistance [ Time Frame: Baseline up to Day 5 ] [ Designated as safety issue: Yes ]Methicillin-resistant Staphylococcus aureus and vancomycin-resistant enterococcus presence at surgery on Day 1 and 5 days after surgery
|Study Start Date:||January 2012|
|Study Completion Date:||May 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Progressive cohorts of 10 subjects (8 active, 2 placebo) receiving 10, 20 , 30 or 40 mL of DFA-02 or matching placebo.
Modified release product containing gentamicin and vancomycin for application at the conclusion of surgery after closure of the fascia and prior to skin closure
|Placebo Comparator: DFA-02 placebo||
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.
|United States, Alabama|
|Florence, Alabama, United States|
|United States, Florida|
|Tampa, Florida, United States|
|United States, Ohio|
|Columbus, Ohio, United States|
|United States, Texas|
|Bellaire, Texas, United States|
|Temple, Texas, United States|
|Study Director:||Kent Allenby, MD||Dr. Reddy's Laboratories|