Back to resultsVashe Wound Therapy Study
Primary Purpose
Burns
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vashe
Mafenide acetate
Sponsored by
About this trial
This is an interventional treatment trial for Burns focused on measuring Burn, Burn wound management, Burn graft
Eligibility 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
Sites / Locations
- Maricopa Integrated Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vashe
5% Mafenide Acetate
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Percentage of Grafted Area That is Viable at Day 14
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
Average hospital length of stay in days
Hospital Cost Per Patient
Average hospital irrigant cost per patient
Full Information
NCT ID
NCT00586729
First Posted
December 21, 2007
Last Updated
September 7, 2012
Sponsor
Valleywise Health
Collaborators
PuriCore, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00586729
Brief Title
Vashe Wound Therapy Study
Official Title
Pilot Study to Evaluate Effectiveness of Vashe™ Wound Therapy as an Antimicrobial Irrigant in Burn Wound Management
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Valleywise Health
Collaborators
PuriCore, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Burn, Burn wound management, Burn graft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vashe
Arm Type
Experimental
Arm Description
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.
Arm Title
5% Mafenide Acetate
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Vashe
Intervention Description
Antimicrobial irrigant
Intervention Type
Drug
Intervention Name(s)
Mafenide acetate
Intervention Description
Antimicrobial solution
Primary Outcome Measure Information:
Title
Percentage of Grafted Area That is Viable at Day 14
Description
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
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Length of Stay
Description
Average hospital length of stay in days
Time Frame
0 days, 3 days, 5 days and 14 days post-operation
Title
Hospital Cost Per Patient
Description
Average hospital irrigant cost per patient
Time Frame
Volume used from admission to discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Foster, MD
Organizational Affiliation
District Medical Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maricopa Integrated Health System
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
12. IPD Sharing Statement
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Vashe Wound Therapy Study
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