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

NCT ID: NCT01888367

Last Updated: 2016-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 445 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-02-28

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.

Conditions

Surgical Site Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

DFA-02 Antibiotic Gel

Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.

Group Type: EXPERIMENTAL

DFA-02 Antibiotic Gel

Intervention Type: DRUG

DFA-02 Placebo Gel

Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.

Group Type: PLACEBO_COMPARATOR

DFA-02 Placebo Gel

Intervention Type: DRUG

Standard of Care

Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

DFA-02 Antibiotic Gel

Intervention Type: DRUG

DFA-02 Placebo Gel

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke Clinical Research Institute

OTHER

Sponsor Role: collaborator

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elliott Bennett-Guerrero, MD

Role: STUDY_DIRECTOR

Duke Clinical Research Institute

Locations

Florence, Alabama, United States

Sheffield, Alabama, United States

Phoenix, Arizona, United States

Tucson, Arizona, United States

Laguna Hills, California, United States

Los Angeles, California, United States

Aurora, Colorado, United States

Washington D.C., District of Columbia, United States

Jacksonville, Florida, United States

Miami, Florida, United States

Tampa, Florida, United States

Weston, Florida, United States

Columbus, Georgia, United States

Powder Springs, Georgia, United States

Indianaoplis, Indiana, United States

Alexandria, Louisiana, United States

New Orleans, Louisiana, United States

Burlington, Massachusetts, United States

Worcester, Massachusetts, United States

Minneapolis, Minnesota, United States

Jackson, Mississippi, United States

Las Vegas, Nevada, United States

Albany, New York, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

Columbus, Ohio, United States

Oklahoma City, Oklahoma, United States

Hershey, Pennsylvania, United States

Bellaire, Texas, United States

Nassau Bay, Texas, United States

Burlington, Vermont, United States

Countries

United States

Other Identifiers

DFA-02-CD-005

Identifier Type: -

Identifier Source: org_study_id