Vashe Wound Therapy Study

Not Applicable

Completed

• Conditions: Burns
• Interventions: Device: Vashe; Drug: Mafenide acetate

• Registration Number: NCT00586729
• Lead Sponsor: Valleywise Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-21
• Study First Submitted QC: 2007-12-21
• Study First Posted: 2008-01-04
• Study Start: 2009-07
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Results First Submitted: 2012-08-09
• Results First Submitted QC: 2012-08-09
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-07
• Results First Posted: 2012-09-10
• Last Update Posted: 2012-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vashe	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.
5% Mafenide Acetate	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Grafted Area That is Viable at Day 14	14 days	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

Name	Time	Method
Length of Stay	0 days, 3 days, 5 days and 14 days post-operation	Average hospital length of stay in days
Hospital Cost Per Patient	Volume used from admission to discharge	Average hospital irrigant cost per patient

Trial Locations

Locations (1)

Maricopa Integrated Health System; 🇺🇸 Phoenix, Arizona, United States