Vashe Wound Therapy Study

September 7, 2012 updated by: Valleywise Health

Pilot Study to Evaluate Effectiveness of Vashe™ Wound Therapy as an Antimicrobial Irrigant in Burn Wound Management

This study will evaluate the efficacy, safety, and tolerability of topical Vashe™ Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist versus 5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85008
        • Maricopa Integrated Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female, aged 18 years and over requiring hospitalization for burn injury
  • Burn injury requiring wound excision and auto-grafting
  • Less than or equal to 20% Total Body Surface Area burns

Exclusion Criteria:

  • Pregnant or lactating females
  • Individuals with chlorine sensitivity
  • Electrical, chemical and cold injury
  • Burns to the face, hands, feet and or perineum area
  • Steroid therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vashe
Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
Device: Vashe
Antimicrobial irrigant
Active Comparator: 5% Mafenide Acetate
5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
Drug: Mafenide acetate
Antimicrobial solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Grafted Area That is Viable at Day 14
Time Frame: 14 days
Percentage area of graft viability at 14 days as determined by clinical assessment of revascularization, adherence of the graft to the wound bed and color
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Stay
Time Frame: 0 days, 3 days, 5 days and 14 days post-operation
Average hospital length of stay in days
0 days, 3 days, 5 days and 14 days post-operation
Hospital Cost Per Patient
Time Frame: Volume used from admission to discharge
Average hospital irrigant cost per patient
Volume used from admission to discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Valleywise Health

Collaborators

PuriCore, Inc.

Investigators

  • Principal Investigator: Kevin Foster, MD, District Medical Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 21, 2007

First Posted (Estimate)

January 4, 2008

Study Record Updates

Last Update Posted (Estimate)

September 14, 2012

Last Update Submitted That Met QC Criteria

September 7, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-012
  • 1200-0007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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