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

August 17, 2016 updated by: Dr. Reddy's Laboratories Limited

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

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 Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

445

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Florence, Alabama, United States
      • Sheffield, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Tucson, Arizona, United States
    • California
      • Laguna Hills, California, United States
      • Los Angeles, California, United States
    • Colorado
      • Aurora, Colorado, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Jacksonville, Florida, United States
      • Miami, Florida, United States
      • Tampa, Florida, United States
      • Weston, Florida, United States
    • Georgia
      • Columbus, Georgia, United States
      • Powder Springs, Georgia, United States
    • Indiana
      • Indianaoplis, Indiana, United States
    • Louisiana
      • Alexandria, Louisiana, United States
      • New Orleans, Louisiana, United States
    • Massachusetts
      • Burlington, Massachusetts, United States
      • Worcester, Massachusetts, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Mississippi
      • Jackson, Mississippi, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New York
      • Albany, New York, United States
      • New York, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
    • Ohio
      • Columbus, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States
    • Texas
      • Bellaire, Texas, United States
      • Nassau Bay, Texas, United States
    • Vermont
      • Burlington, Vermont, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Patients With Surgical Site Infections
Time Frame: Within 30 days of surgery
Within 30 days of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients With Adverse Events
Time Frame: Within 30 days of surgery
Within 30 days of surgery
Change in Serum Creatinine Measurements From Baseline
Time Frame: Within 4 days of surgery
Change from baseline in micromoles/liter
Within 4 days of surgery
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.
Through post-operative Day 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Elliott Bennett-Guerrero, MD, Duke Clinical Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

June 25, 2013

First Submitted That Met QC Criteria

June 26, 2013

First Posted (Estimate)

June 27, 2013

Study Record Updates

Last Update Posted (Estimate)

October 11, 2016

Last Update Submitted That Met QC Criteria

August 17, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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