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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01888367
Recruitment Status : Completed
First Posted : June 27, 2013
Results First Posted : October 11, 2016
Last Update Posted : October 11, 2016
Sponsor:
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Study Description
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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.

Condition or disease Intervention/treatment Phase
Surgical Site Infections Drug: DFA-02 Antibiotic Gel Drug: DFA-02 Placebo Gel Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 445 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : October 2013
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: DFA-02 Antibiotic Gel
Placebo Comparator: 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.
 Drug: DFA-02 Placebo Gel
No Intervention: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of Patients With Surgical Site Infections [ Time Frame: Within 30 days of surgery ]

Secondary Outcome Measures :
  1. Number of Patients With Adverse Events [ Time Frame: Within 30 days of surgery ]
  2. Change in Serum Creatinine Measurements From Baseline [ Time Frame: Within 4 days of surgery ]
    Change from baseline in micromoles/liter

  3. Cumulative ASEPSIS Score for Each Patient [ Time Frame: Through post-operative Day 4 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888367


Locations
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United States, Alabama
Florence, Alabama, United States
Sheffield, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
Tucson, Arizona, United States
United States, California
Laguna Hills, California, United States
Los Angeles, California, United States
United States, Colorado
Aurora, Colorado, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Jacksonville, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Weston, Florida, United States
United States, Georgia
Columbus, Georgia, United States
Powder Springs, Georgia, United States
United States, Indiana
Indianaoplis, Indiana, United States
United States, Louisiana
Alexandria, Louisiana, United States
New Orleans, Louisiana, United States
United States, Massachusetts
Burlington, Massachusetts, United States
Worcester, Massachusetts, United States
United States, Minnesota
Minneapolis, Minnesota, United States
United States, Mississippi
Jackson, Mississippi, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New York
Albany, New York, United States
New York, New York, United States
United States, North Carolina
Chapel Hill, North Carolina, United States
United States, Ohio
Columbus, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Pennsylvania
Hershey, Pennsylvania, United States
United States, Texas
Bellaire, Texas, United States
Nassau Bay, Texas, United States
United States, Vermont
Burlington, Vermont, United States
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Duke Clinical Research Institute
Investigators
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Study Director: Elliott Bennett-Guerrero, MD Duke Clinical Research Institute
More Information
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Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01888367    
Other Study ID Numbers: DFA-02-CD-005
First Posted: June 27, 2013    Key Record Dates
Results First Posted: October 11, 2016
Last Update Posted: October 11, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Surgical Wound Infection
Wound Infection
Infections
Postoperative Complications
 Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents