Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery
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|ClinicalTrials.gov Identifier: NCT01888367|
Recruitment Status : Completed
First Posted : June 27, 2013
Results First Posted : October 11, 2016
Last Update Posted : October 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Surgical Site Infections||Drug: DFA-02 Antibiotic Gel Drug: DFA-02 Placebo Gel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||445 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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 Start Date :||October 2013|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||February 2015|
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.
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.
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.
- Number of Patients With Surgical Site Infections [ Time Frame: Within 30 days of surgery ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888367
Show 31 Study Locations
|Study Director:||Elliott Bennett-Guerrero, MD||Duke Clinical Research Institute|