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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

Tracking Information
First Submitted Date  ICMJE June 25, 2013
First Posted Date  ICMJE June 27, 2013
Results First Submitted Date  ICMJE March 23, 2016
Results First Posted Date  ICMJE October 11, 2016
Last Update Posted Date October 11, 2016
Study Start Date  ICMJE October 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2013)
Number of Patients With Surgical Site Infections [ Time Frame: Within 30 days of surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2016)
  • Number of Patients With Adverse Events [ Time Frame: 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2013)
  • Number of Patients With Adverse Events [ Time Frame: Within 30 days of surgery ]
  • Incidence of antibiotic resistance in bacterial cultures from any surgical site infections [ Time Frame: Within 30 days of surgery ]
  • Change in Serum Creatinine Measurements From Baseline [ Time Frame: Within 4 days of surgery ]
  • Cumulative ASEPSIS Score for Each Patient [ Time Frame: Through post-operative Day 4 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Surgical Site Infections
Intervention  ICMJE
  • Drug: DFA-02 Antibiotic Gel
  • Drug: DFA-02 Placebo Gel
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2015)
445
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2013)
450
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01888367
Other Study ID Numbers  ICMJE DFA-02-CD-005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Reddy's Laboratories Limited
Study Sponsor  ICMJE Dr. Reddy's Laboratories Limited
Collaborators  ICMJE Duke Clinical Research Institute
Investigators  ICMJE
Study Director: Elliott Bennett-Guerrero, MD Duke Clinical Research Institute
PRS Account Dr. Reddy's Laboratories Limited
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP