MedTrace Logo

DFA-02 in Patients Undergoing Colorectal Surgery

NCT01496352 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2014-09-01

Study results available
· View outcomes & findings →

Summary

This is a randomized, double-blind, placebo controlled, safety, tolerability, and pharmacokinetic dose escalation Phase II study of DFA-02 in patients undergoing colorectal surgery to evaluate the safety, tolerability and pharmacokinetics of DFA-02.

Conditions

  • Surgical Site Infection

Interventions

DRUG

DFA-02

Modified release product containing gentamicin and vancomycin for application at the conclusion of surgery after closure of the fascia and prior to skin closure

DRUG

Placebo

DFA-02 placebo

Sponsors & Collaborators

  • Duke Clinical Research Institute

    collaborator OTHER

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Kent Allenby, MD · Dr. Reddy's Laboratories

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-04-30
Completion
2013-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01496352 on ClinicalTrials.gov