Vashe Wound Therapy Study

Valleywise Health23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Burns

Interventions

VasheDEVICE

Antimicrobial irrigant

Mafenide acetateDRUG

Antimicrobial solution

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Maricopa Integrated Health System

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

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

Time frame: 14 days

Secondary Outcomes

Length of Stay

Average hospital length of stay in days

Time frame: 0 days, 3 days, 5 days and 14 days post-operation

Hospital Cost Per Patient

Average hospital irrigant cost per patient

Time frame: Volume used from admission to discharge

Data from ClinicalTrials.gov

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