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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: Completed Phase 2 study, sponsored by Dr. Reddy's Laboratories Limited.

NCT01888367 is a Phase 2 study that has completed, run by Dr. Reddy's Laboratories Limited. The registered enrollment target is 445 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (235% higher). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 445 participants
Start Date 2013-10
Est. Completion 2015-02
Phase Phase 2
Dr. Reddy's Laboratories Limited

52 total trials

What the finished NCT01888367 record still lists

NCT01888367 is an interventional study that assigns participants to a tested intervention. The registered 445 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (235% higher).

The record links to 0 conditions, and to 2 interventions - of which DFA-02 Antibiotic Gel is the first listed.

NCT01888367 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01888367's enrollment target sits among peer trials

445 89th of 2000 higher than 1,912 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01888367, the US trial registry maintained by the National Library of Medicine. NCT01888367 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.