Vashe Wound Therapy Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Burns

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Vashe

Intervention Type DEVICE

Antimicrobial irrigant

5% 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.

Group Type ACTIVE_COMPARATOR

Mafenide acetate

Intervention Type DRUG

Antimicrobial solution

Interventions

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Vashe

Antimicrobial irrigant

Intervention Type DEVICE

Mafenide acetate

Antimicrobial solution

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No