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Vashe Wound Therapy Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00586729
First Posted: January 4, 2008
Last Update Posted: September 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
PuriCore, Inc.
Information provided by (Responsible Party):
Maricopa Integrated Health System
  Purpose
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.

Condition Intervention
Burns Device: Vashe Drug: Mafenide acetate

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study to Evaluate Effectiveness of Vashe™ Wound Therapy as an Antimicrobial Irrigant in Burn Wound Management

Resource links provided by NLM:


Further study details as provided by Maricopa Integrated Health System:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Length of Stay [ Time Frame: 0 days, 3 days, 5 days and 14 days post-operation ]
    Average hospital length of stay in days

  • Hospital Cost Per Patient [ Time Frame: Volume used from admission to discharge ]
    Average hospital irrigant cost per patient


Enrollment: 23
Study Start Date: July 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00586729


Locations
United States, Arizona
Maricopa Integrated Health System
Phoenix, Arizona, United States, 85008
Sponsors and Collaborators
Maricopa Integrated Health System
PuriCore, Inc.
Investigators
Principal Investigator: Kevin Foster, MD District Medical Group
  More Information

Responsible Party: Maricopa Integrated Health System
ClinicalTrials.gov Identifier: NCT00586729     History of Changes
Other Study ID Numbers: 2007-012
1200-0007
First Submitted: December 21, 2007
First Posted: January 4, 2008
Results First Submitted: August 9, 2012
Results First Posted: September 10, 2012
Last Update Posted: September 14, 2012
Last Verified: September 2012

Keywords provided by Maricopa Integrated Health System:
Burn
Burn wound management
Burn graft

Additional relevant MeSH terms:
Anti-Infective Agents
Mafenide
Anti-Bacterial Agents
Anti-Infective Agents, Local