CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
VAC VeraFlo with Dakins Instillation +1 moredevice
Likely dose
Not stated in 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/NCT02009501
NCT02009501N/ACompleted
CompareCT.gov

A Prospective, Open, Comparative, Randomized Single-center Study to Evaluate the Effect of V.A.C. VeraFlo™ Therapy With .125% Dakins vs V.A.C. Ulta™ Therapy on Biofilm Removal/Disruption/Elimination in Chronically Infected Wounds

St. Luke's-Roosevelt Hospital Center·interventional·Posted Dec 12, 2013·Updated Nov 27, 2018

In Brief

A clinical study evaluating VAC VeraFlo with Dakins Instillation and VAC Ulta Therapy for Lower Extremity Wound Infected and Venous Stasis Ulcers. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This study would like to determine if using negative pressure wound therapy with an instillation of .125% Dakins is more effective than using negative pressure wound therapy alone on biofilm removal, disruption and elimination in chronically infected lower extremity wounds.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLower Extremity Wound Infected, Venous Stasis Ulcers
CountriesUnited States
CollaboratorsKinetic Concepts, Inc.

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 12, 2013
Enrollment StartNov 1, 2013
Primary CompletionMay 1, 2015
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 12.6 years ago

Interventions

VAC VeraFlo with Dakins Instillationdevice

VAC VeraFlo with Dakins instillation will be placed in the operating room after surgical debridement. Biopsies will be obtained prior to surgical debridement, after surgical debridement, on day 4, and on day 7.

VAC Ulta Therapydevice

VAC ULTA will be placed in the operating room after surgical debridement. Biopsies will be obtained prior to surgical debridement, after surgical debridement, on day 4, and on day 7.