Vashe Wound Therapy Study

This study has been completed.
Sponsor:
Collaborator:
PuriCore, Inc.
Information provided by (Responsible Party):
Maricopa Integrated Health System
ClinicalTrials.gov Identifier:
NCT00586729
First received: December 21, 2007
Last updated: September 7, 2012
Last verified: September 2012
  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: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Average hospital length of stay in days

  • Hospital Cost Per Patient [ Time Frame: Volume used from admission to discharge ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Maricopa Integrated Health System
ClinicalTrials.gov Identifier: NCT00586729     History of Changes
Other Study ID Numbers: 2007-012, 1200-0007
Study First Received: December 21, 2007
Results First Received: August 9, 2012
Last Updated: September 7, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Anti-Infective Agents
Mafenide
Therapeutic Uses
Pharmacologic Actions
Anti-Infective Agents, Local

ClinicalTrials.gov processed this record on April 20, 2014