Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery
Public ClinicalTrials.gov record NCT01888367. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01888367
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 445 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2013 (Type not available)
- Primary completion
- Feb 2015 (Actual)
- Completion
- Feb 2015 (Actual)
- Last update posted
- Oct 11, 2016
2013 – 2015
United States locations
- U.S. sites
- 31
- U.S. states
- 20
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Florence | Alabama | — | — |
| Not listed | Sheffield | Alabama | — | — |
| Not listed | Phoenix | Arizona | — | — |
| Not listed | Tucson | Arizona | — | — |
| Not listed | Laguna Hills | California | — | — |
| Not listed | Los Angeles | California | — | — |
| Not listed | Aurora | Colorado | — | — |
| Not listed | Washington D.C. | District of Columbia | — | — |
| Not listed | Jacksonville | Florida | — | — |
| Not listed | Miami | Florida | — | — |
| Not listed | Tampa | Florida | — | — |
| Not listed | Weston | Florida | — | — |
| Not listed | Columbus | Georgia | — | — |
| Not listed | Powder Springs | Georgia | — | — |
| Not listed | Indianaoplis | Indiana | — | — |
| Not listed | Alexandria | Louisiana | — | — |
| Not listed | New Orleans | Louisiana | — | — |
| Not listed | Burlington | Massachusetts | — | — |
| Not listed | Worcester | Massachusetts | — | — |
| Not listed | Minneapolis | Minnesota | — | — |
| Not listed | Jackson | Mississippi | — | — |
| Not listed | Las Vegas | Nevada | — | — |
| Not listed | Albany | New York | — | — |
| Not listed | New York | New York | — | — |
| Not listed | Chapel Hill | North Carolina | — | — |
| Not listed | Columbus | Ohio | — | — |
| Not listed | Oklahoma City | Oklahoma | — | — |
| Not listed | Hershey | Pennsylvania | — | — |
| Not listed | Bellaire | Texas | — | — |
| Not listed | Nassau Bay | Texas | — | — |
| Not listed | Burlington | Vermont | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01888367, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 11, 2016 · Synced Oct 29, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01888367 live on ClinicalTrials.gov.