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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
445
Unnamed facility
Florence, Alabama, United States
Unnamed facility
Sheffield, Alabama, United States
Unnamed facility
Phoenix, Arizona, United States
Unnamed facility
Tucson, Arizona, United States
Unnamed facility
Laguna Hills, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Washington D.C., District of Columbia, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Miami, Florida, United States
...and 21 more locations
Number of Patients With Surgical Site Infections
Time frame: Within 30 days of surgery
Number of Patients With Adverse Events
Time frame: Within 30 days of surgery
Change in Serum Creatinine Measurements From Baseline
Change from baseline in micromoles/liter
Time frame: Within 4 days of surgery
Cumulative ASEPSIS Score for Each Patient
Total ASEPSIS score with a range of 0-65 points with lower scores being better. The score is the sum of: Antibiotic Use (10 points), Drainage of Pus Under Local Anesthesia (5 points), Debridement Under General Anesthesia (10 points), Serous Discharge (5 points), Erythema (5 points), Purulent Exudate (5 points), Separation of Deep Tissues (10 points) and Isolation of Bacteria from Discharge (10 points). Source: Wilson AP, Treasure T, Sturridge MF, Gruneberg RN. Lancet. 1986:1(8476):311-3.
Time frame: Through post-operative Day 4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.