N/A N=23 Treatment

Vashe Wound Therapy Study

Burns

Bottom Line

View on ClinicalTrials.gov: NCT00586729 ↗

Enrolled (actual)

Serious AEs

15.8%

Results posted

Sep 2012

Primary outcome: Primary: Percentage of Grafted Area That is Viable at Day 14 — 96.3; 96.0 Percentage area

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Vashe (Device); Mafenide acetate (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Valleywise Health
Primary completion: Nov 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Grafted Area That is Viable at Day 14	96.3; 96.0	—
SECONDARY Length of Stay	21.5; 15.6	—
SECONDARY Hospital Cost Per Patient	249.38; 393.00	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00586729). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.