Title
Vashe Wound Therapy Study
Pilot Study to Evaluate Effectiveness of Vashe™ Wound Therapy as an Antimicrobial Irrigant in Burn Wound Management
Phase
N/ALead Sponsor
University of ArizonaStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
BurnsIntervention/Treatment
mafenide acetate hypochlorous acid ...Study Participants
23This 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.
Antimicrobial irrigant
Antimicrobial solution
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.
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
| Event Type | Organ System | Event Term | Vashe | 5% Mafenide Acetate |
|---|
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
Average hospital length of stay in days
Average hospital irrigant cost per patient
