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NCT01888367 · ClinicalTrials.gov registry record · Phase 2
Safety, Efficacy and Tolerability Study of up to 20 mL of DFA-02 in Patients Undergoing Abdominal Surgery
A Phase 2 study, sponsored by Dr. Reddy's Laboratories Limited.
- Completed
- Registry status
- Phase 2
- Development phase
- 445
- Enrollment target
NCT01888367 is a Phase 2 study that has completed, run by Dr. Reddy's Laboratories Limited. The registered enrollment target is 445 participants.
The verdict
NCT01888367, a Phase 2 study, has completed, sponsored by Dr. Reddy's Laboratories Limited.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 445 participants
- Enrollment target
Study 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.
Interventions
- DRUG DFA-02 Antibiotic Gel
- DRUG DFA-02 Placebo Gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 445 participants |
| Start Date | 2013-10 |
| Est. Completion | 2015-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01888367
The ClinicalTrials.gov registry entry for NCT01888367 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 445 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Dr. Reddy's Laboratories Limited, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which DFA-02 Antibiotic Gel is the first listed.
NCT01888367 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01888367 about?
NCT01888367 is a clinical study titled "Safety, Efficacy 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 ...
What is the current status of trial NCT01888367?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 445 participants. The study started on 2013-10. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01888367?
The interventions under investigation include: DFA-02 Antibiotic Gel (DRUG), DFA-02 Placebo Gel (DRUG).
Who is sponsoring clinical trial NCT01888367?
This trial is sponsored by Dr. Reddy's Laboratories Limited, which has 52 total clinical trials registered on ClinicalTrials.gov.
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