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Study to Evaluate Efficacy and Safety of E-101 Solution for Preventing Surgical Site Infections After Colorectal Surgery

NCT01297959 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 503

Last updated 2021-02-10

Study results available
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Summary

This study is intended to determine the efficacy, safety and tolerability of topical application of E-101 Solution directly into the surgical incisional wound in the prevention of infection of superficial and deep surgical incisional wounds. E-101 Solution is an enzyme-based antiseptic that is being developed for direct application to a surgical incision.

Conditions

Interventions

DRUG

E-101 Solution 300 GU/ml

8 mL of E-101 Solution

DRUG

Saline solution

Saline solution matched to E-101

Sponsors & Collaborators

  • Veristat, Inc.

    collaborator OTHER

  • Biotec Services International Ltd

    collaborator OTHER

  • Eurofins

    collaborator INDUSTRY

  • CBR International Corp.

    collaborator INDUSTRY

  • Excited States, LLC

    lead INDUSTRY

Principal Investigators

  • Peter O'Hanley, PhD, MD, MPH · Excited States, LLC

  • Robert Martindale, MD, PhD · Oregon Health and Science University

  • Michael J Stamos, MD · University of California, Irvine

  • Jerrold H Levy, MD · Emory Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-10
Primary Completion
2015-10-14
Completion
2015-10-14
FDA Drug
Yes

Countries

  • United States
  • Israel

Study Locations

More Related Trials

Entities

Diseases

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 NCT01297959 on ClinicalTrials.gov