Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery
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
1 other identifier
interventional
445
1 country
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2013
Shorter than P25 for phase_2
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2013
CompletedFirst Posted
Study publicly available on registry
June 27, 2013
CompletedStudy Start
First participant enrolled
October 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedResults Posted
Study results publicly available
October 11, 2016
CompletedOctober 11, 2016
August 1, 2016
1.3 years
June 25, 2013
March 23, 2016
August 17, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Patients With Surgical Site Infections
Within 30 days of surgery
Secondary Outcomes (3)
Number of Patients With Adverse Events
Within 30 days of surgery
Change in Serum Creatinine Measurements From Baseline
Within 4 days of surgery
Cumulative ASEPSIS Score for Each Patient
Through post-operative Day 4
Study Arms (3)
DFA-02 Antibiotic Gel
EXPERIMENTALUp to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.
DFA-02 Placebo Gel
PLACEBO COMPARATORUp to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.
Standard of Care
NO INTERVENTIONPrior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
Interventions
Eligibility Criteria
You may qualify if:
- Males and females 18 years of age or older;
- 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;
- Body mass index (BMI) ≥ 20;
- Scheduled to undergo non-emergent abdominal surgery involving a planned incision of 7 cm or greater;
- Willing and able to give informed consent;
- Available for evaluation from Baseline until final evaluation at 30 days post-surgery.
You may not qualify if:
- Known hypersensitivity to gentamicin, vancomycin, other aminoglycoside antibiotics or the excipients of the study products;
- Emergency surgery;
- Significant concomitant surgical procedure;
- Prior laparotomy within the last 60 days of the planned procedure;
- Planned second laparotomy or abdominal surgical procedure within 30 days of the planned first procedure;
- Expectation that a surgical drain will be placed in the incision;
- Preoperative sepsis, severe sepsis, or septic shock;
- Abdominal wall infection/surgical site infection from previous laparotomy/laparoscopy or for any reason;
- 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;
- Requirement for gentamicin or vancomycin preoperative antimicrobial prophylaxis;
- Concurrent systemic use of other potentially neurotoxic, nephrotoxic, and/or ototoxic drugs;
- Preoperative evaluation suggesting an intra-abdominal process that might preclude full closure of the skin;
- Ongoing treatment (e.g. chemotherapy, radiation) for non-colorectal cancer;
- History of significant drug or alcohol abuse;
- Serum Creatinine \> 1.8 mg/dL;
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dr. Reddy's Laboratories Limitedlead
- Duke Clinical Research Institutecollaborator
Study Sites (31)
Unknown Facility
Florence, Alabama, United States
Unknown Facility
Sheffield, Alabama, United States
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Laguna Hills, California, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Aurora, Colorado, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Tampa, Florida, United States
Unknown Facility
Weston, Florida, United States
Unknown Facility
Columbus, Georgia, United States
Unknown Facility
Powder Springs, Georgia, United States
Unknown Facility
Indianaoplis, Indiana, United States
Unknown Facility
Alexandria, Louisiana, United States
Unknown Facility
New Orleans, Louisiana, United States
Unknown Facility
Burlington, Massachusetts, United States
Unknown Facility
Worcester, Massachusetts, United States
Unknown Facility
Minneapolis, Minnesota, United States
Unknown Facility
Jackson, Mississippi, United States
Unknown Facility
Las Vegas, Nevada, United States
Unknown Facility
Albany, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Chapel Hill, North Carolina, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Hershey, Pennsylvania, United States
Unknown Facility
Bellaire, Texas, United States
Unknown Facility
Nassau Bay, Texas, United States
Unknown Facility
Burlington, Vermont, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The number of culture positive SSIs were too small to draw any conclusions on antibiotic resistance.
Results Point of Contact
- Title
- VP, Drug Development
- Organization
- Promius Pharma, LLC, Dr. Reddy's Laboratories
Study Officials
- STUDY DIRECTOR
Elliott Bennett-Guerrero, MD
Duke Clinical Research Institute
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2013
First Posted
June 27, 2013
Study Start
October 1, 2013
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
October 11, 2016
Results First Posted
October 11, 2016
Record last verified: 2016-08