CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 503 enrolled
Drug / intervention
E-101 Solution 300 GU/ml +1 moredrug
Likely dose
E-101 Solution 300 GU/ml 8 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01297959
NCT01297959Phase 3Completed
CompareCT.gov

Phase 3 Study of Efficacy and Safety of Topical E-101 Solution to Prevent Incisional Infections Among Colorectal Surgery Patients (Triple IN Study --Inhibition of Incisional Infections)

Excited States, LLC·interventional·Posted Feb 17, 2011·Updated Feb 10, 2021

In Brief

A Phase 3 clinical trial evaluating E-101 Solution 300 GU/ml and Saline solution for Infections. Completed, enrolled 503 participants across 39 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections
CountriesIsrael, United States
CollaboratorsVeristat, Inc., Biotec Services International Ltd, Eurofins, CBR International Corp.

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 17, 2011
Enrollment StartJan 10, 2013
Primary CompletionOct 14, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 15.4 years ago

Interventions

E-101 Solution 300 GU/mldrug

8 mL of E-101 Solution

Saline solutiondrug

Saline solution matched to E-101