Clinical trial NCT01888367: Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Surgical Site Infections
Lead sponsor: Dr. Reddy's Laboratories Limited
Sponsor class: INDUSTRY
Collaborators: name: Duke Clinical Research Institute
First posted: 2013-06-27
Enrollment: 445
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. Males and females 18 years of age or older;
2. If female, the subject must be postmenopausal, surgically sterilized or, if of child-bearing potential, she must have a negative serum or urine pregnancy test within 48 hours of surgery and agree to use adequate birth control during the study and for 30 days after the administration of study agent;
3. Body mass index (BMI) ≥ 20;
4. Scheduled to undergo non-emergent abdominal surgery involving a planned incision of 7 cm or greater;
5. Willing and able to give informed consent;
6. Available for evaluation from Baseline until final evaluation at 30 days post-surgery.

Exclusion Criteria:

1. Known hypersensitivity to gentamicin, vancomycin, other aminoglycoside antibiotics or the excipients of the study products;
2. Emergency surgery;
3. Significant concomitant surgical procedure;
4. Prior laparotomy within the last 60 days of the planned procedure;
5. Planned second laparotomy or abdominal surgical procedure within 30 days of the planned first procedure;
6. Expectation that a surgical drain will be placed in the incision;
7. Preoperative sepsis, severe sepsis, or septic shock;
8. Abdominal wall infection/surgical site infection from previous laparotomy/laparoscopy or for any reason;
9. Active systemic infection or systemic (oral or intravenous) antibiotic therapy within the 1 week prior to the date of surgery other than specified preoperative antimicrobial prophylaxis;
10. Requirement for gentamicin or vancomycin preoperative antimicrobial prophylaxis;
11. Concurrent systemic use of other potentially neurotoxic, nephrotoxic, and/or ototoxic drugs;
12. Preoperative evaluation suggesting an intra-abdominal process that might preclude full closure of the skin;
13. Ongoing treatment (e.g. chemotherapy, radiation) for non-colorectal cancer;
14. History of significant drug or alcohol abuse;
15. Serum Creatinine \> 1.8 mg/dL;
16. Serum Bilirubin \> 2.5 times upper limit of normal;
17. Subjects who are immunocompromised including but not limited to systemic corticosteroid use or chemotherapy/radiation during the 30 days prior to surgery, organ transplantation, or HIV infection;
18. Known history of HIV;
19. Pregnant or lactating, or if of childbearing potential not practicing a birth control method with a high degree of reliability;
20. Refusal to accept medically indicated blood products;
21. Participation within 30 days before the start of this study in any experimental drug or device study, or currently participating in a study in which the administration of investigational drug or device within 60 days is anticipated;
22. Unable to participate in the study for any reason in the opinion of the Principal Investigator;
23. Postsurgical life expectancy of less than 30 days;
24. Expected discharge from the hospital less than 3 days after surgery.

Primary outcomes:
measure: Number of Patients With Surgical Site Infections
timeFrame: Within 30 days of surgery
Secondary outcomes:
measure: Number of Patients With Adverse Events
timeFrame: Within 30 days of surgery
measure: Change in Serum Creatinine Measurements From Baseline
timeFrame: Within 4 days of surgery
measure: Cumulative ASEPSIS Score for Each Patient
timeFrame: Through post-operative Day 4
Other outcomes:
Locations:
city: Florence
country: United States
state: Alabama
city: Sheffield
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Laguna Hills
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Weston
country: United States
state: Florida
city: Columbus
country: United States
state: Georgia
city: Powder Springs
country: United States
state: Georgia
city: Indianaoplis
country: United States
state: Indiana
city: Alexandria
country: United States
state: Louisiana
city: New Orleans
country: United States
state: Louisiana
city: Burlington
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Minneapolis
country: United States
state: Minnesota
city: Jackson
country: United States
state: Mississippi
city: Las Vegas
country: United States
state: Nevada
city: Albany
country: United States
state: New York
city: New York
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Hershey
country: United States
state: Pennsylvania
city: Bellaire
country: United States
state: Texas
city: Nassau Bay
country: United States
state: Texas
city: Burlington
country: United States
state: Vermont
Study officials:
affiliation: Duke Clinical Research Institute
name: Elliott Bennett-Guerrero, MD
role: STUDY_DIRECTOR
References: