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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 26, 2014