Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery
Primary Purpose
Surgical Site Infections
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DFA-02 Antibiotic Gel
DFA-02 Placebo Gel
Sponsored by
About this trial
This is an interventional prevention trial for Surgical Site Infections
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- Serum Bilirubin > 2.5 times upper limit of normal;
- 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;
- Known history of HIV;
- Pregnant or lactating, or if of childbearing potential not practicing a birth control method with a high degree of reliability;
- Refusal to accept medically indicated blood products;
- 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;
- Unable to participate in the study for any reason in the opinion of the Principal Investigator;
- Postsurgical life expectancy of less than 30 days;
- Expected discharge from the hospital less than 3 days after surgery.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
DFA-02 Antibiotic Gel
DFA-02 Placebo Gel
Standard of Care
Arm Description
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.
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.
Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
Outcomes
Primary Outcome Measures
Number of Patients With Surgical Site Infections
Secondary Outcome Measures
Number of Patients With Adverse Events
Change in Serum Creatinine Measurements From Baseline
Change from baseline in micromoles/liter
Cumulative ASEPSIS Score for Each Patient
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.
Full Information
NCT ID
NCT01888367
First Posted
June 25, 2013
Last Updated
August 17, 2016
Sponsor
Dr. Reddy's Laboratories Limited
Collaborators
Duke Clinical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01888367
Brief Title
Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery
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 Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Reddy's Laboratories Limited
Collaborators
Duke Clinical Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
445 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DFA-02 Antibiotic Gel
Arm Type
Experimental
Arm Description
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.
Arm Title
DFA-02 Placebo Gel
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
Intervention Type
Drug
Intervention Name(s)
DFA-02 Antibiotic Gel
Intervention Type
Drug
Intervention Name(s)
DFA-02 Placebo Gel
Primary Outcome Measure Information:
Title
Number of Patients With Surgical Site Infections
Time Frame
Within 30 days of surgery
Secondary Outcome Measure Information:
Title
Number of Patients With Adverse Events
Time Frame
Within 30 days of surgery
Title
Change in Serum Creatinine Measurements From Baseline
Description
Change from baseline in micromoles/liter
Time Frame
Within 4 days of surgery
Title
Cumulative ASEPSIS Score for Each Patient
Description
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.
Time Frame
Through post-operative Day 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
Serum Bilirubin > 2.5 times upper limit of normal;
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;
Known history of HIV;
Pregnant or lactating, or if of childbearing potential not practicing a birth control method with a high degree of reliability;
Refusal to accept medically indicated blood products;
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;
Unable to participate in the study for any reason in the opinion of the Principal Investigator;
Postsurgical life expectancy of less than 30 days;
Expected discharge from the hospital less than 3 days after surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elliott Bennett-Guerrero, MD
Organizational Affiliation
Duke Clinical Research Institute
Official's Role
Study Director
Facility Information:
City
Florence
State/Province
Alabama
Country
United States
City
Sheffield
State/Province
Alabama
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Laguna Hills
State/Province
California
Country
United States
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Los Angeles
State/Province
California
Country
United States
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Aurora
State/Province
Colorado
Country
United States
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Washington
State/Province
District of Columbia
Country
United States
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Jacksonville
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
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Tampa
State/Province
Florida
Country
United States
City
Weston
State/Province
Florida
Country
United States
City
Columbus
State/Province
Georgia
Country
United States
City
Powder Springs
State/Province
Georgia
Country
United States
City
Indianaoplis
State/Province
Indiana
Country
United States
City
Alexandria
State/Province
Louisiana
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
City
Burlington
State/Province
Massachusetts
Country
United States
City
Worcester
State/Province
Massachusetts
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
Jackson
State/Province
Mississippi
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Albany
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Chapel Hill
State/Province
North Carolina
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Hershey
State/Province
Pennsylvania
Country
United States
City
Bellaire
State/Province
Texas
Country
United States
City
Nassau Bay
State/Province
Texas
Country
United States
City
Burlington
State/Province
Vermont
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery
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