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Completed

NCT Number: NCT00586729

Vashe Wound Therapy Study

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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Key information

Conditions

Burns Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maricopa Integrated Health System

Phoenix, Arizona, 85008, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vashe

Device

Antimicrobial irrigant

Mafenide acetate

Drug

Antimicrobial solution

Primary outcomes

  1. Percentage of Grafted Area That is Viable at Day 14

    Time frame: 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 outcomes

  1. Length of Stay

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

    Average hospital length of stay in days

  2. Hospital Cost Per Patient

    Time frame: Volume used from admission to discharge

    Average hospital irrigant cost per patient

Sponsors and collaborators

Lead sponsor

Valleywise Health

Other

Collaborators

  • PuriCore, Inc.

Registry information

Official study title

Pilot Study to Evaluate Effectiveness of Vashe™ Wound Therapy as an Antimicrobial Irrigant in Burn Wound Management

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 4, 2008
Registry last updated
Sep 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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