Vashe Wound Therapy Study

Valleywise Health

Status: Completed

Conditions: Burns

Treatments: Drug: Mafenide acetate; Device: Vashe

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00586729

1200-0007

2007-012

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Vashe

Experimental group

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.

Treatment:

Device: Vashe

5% Mafenide Acetate

Active Comparator group

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.

Treatment:

Drug: Mafenide acetate