Surgical Site InfectionsPhase 2NCT01888367
Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery
A Phase 2 study testing DFA-02 Antibiotic Gel in people with Surgical Site Infections, run by Dr. Reddy's Laboratories Limited at 31 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Site Infections
- What is being tested?
- DFA-02 Antibiotic Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 445 participants
- Where
- 31 sitesUnited States
- Study dates
- Oct 2013to Feb 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Study site
Albany, New York
Study site
Alexandria, Louisiana
Study site
Aurora, Colorado
Study site
Bellaire, Texas
Study site
Burlington, Massachusetts
Study site
Burlington, Vermont
Study site
Chapel Hill, North Carolina
Study site
Columbus, Georgia
Study site
Columbus, Ohio
Study site
Florence, Alabama
Study site
Hershey, Pennsylvania
Study site
Indianaoplis, Indiana
Study site
Jackson, Mississippi
Study site
Jacksonville, Florida
Study site
Laguna Hills, California
Study site
Las Vegas, Nevada
Study site
Los Angeles, California
Study site
Miami, Florida
Study site
Minneapolis, Minnesota
Study site
Nassau Bay, Texas
Study site
New Orleans, Louisiana
Study site
New York, New York
Study site
Oklahoma City, Oklahoma
Study site
Phoenix, Arizona
Study site
Powder Springs, Georgia
Study site
Sheffield, Alabama
Study site
Tampa, Florida
Study site
Tucson, Arizona
Study site
Washington D.C., District of Columbia
Study site
Weston, Florida
Study site
Worcester, Massachusetts
About this study
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
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.
- Conditions
- Surgical Site Infections
- Being tested
- DFA-02 Antibiotic Gel, DFA-02 Placebo Gel
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFA-02 Antibiotic GelDrug
DFA-02 Placebo GelDrug
| Study group | Role | What they receive |
|---|---|---|
| DFA-02 Antibiotic Gel | Experimental | 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. Receives: Drug: DFA-02 Antibiotic Gel |
| DFA-02 Placebo Gel | Placebo comparator | 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. Receives: Drug: DFA-02 Placebo Gel |
| Standard of Care | No intervention | Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Surgical Site Infections
Measured: Within 30 days of surgery
Secondary outcomes (3)
Number of Patients With Adverse Events
Measured: Within 30 days of surgery
Change in Serum Creatinine Measurements From Baseline
Change from baseline in micromoles/liter
Measured: Within 4 days of surgery
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.
Measured: Through post-operative Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Surgical Site InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 445 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- Elliott Bennett-Guerrero, MD, Study director, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888367
- Sponsor's protocol ID
- DFA-02-CD-005
- Status last verified
- Aug 2016
- First submitted
- 25 Jun 2013
- Last updated
- 11 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01888367
- Acronym / sponsor ID
- DFA-02-CD-005
- Conditions
- Surgical Site Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 445 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Duke Clinical Research Institute
- Study start
- Oct 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 27 Jun 2013 (estimated)
- Results
- Posted 11 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DFA-02 Antibiotic Gel | Experimental | Drug: DFA-02 Antibiotic GelUp 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 comparator | Drug: DFA-02 Placebo GelUp 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 intervention | –Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (24 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DFA-02 Antibiotic Gel | Drug | DFA-02 Antibiotic Gel |
| DFA-02 Placebo Gel | Drug | DFA-02 Placebo Gel |
Primary outcome
Number of Patients With Surgical Site Infections
Time frame: Within 30 days of surgery
3 secondary outcomes
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
Cumulative ASEPSIS Score for Each Patient
Time frame: Through post-operative Day 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elliott Bennett-Guerrero, MD study director
Duke Clinical Research Institute
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DFA-02 Antibiotic Gel in people with Surgical Site Infections, run by Dr. Reddy's Laboratories Limited at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Surgical Site Infections (time frame: Within 30 days of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2016.