Vashe Wound Therapy Study

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00586729
• Other study ID #: 2007-012
• Secondary ID: 1200-0007
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: September 7, 2012
• Start date: July 2009
• Est. completion date: November 2010

Study information

• Verified date: September 2012
• Source: Maricopa Integrated Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns

Intervention

Device:
• Vashe
Antimicrobial irrigant

Drug:
• Mafenide acetate
Antimicrobial solution

Locations

Country	Name	City	State
United States	Maricopa Integrated Health System	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Maricopa Integrated Health System	PuriCore, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Grafted Area That is Viable at Day 14	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	14 days	No
Secondary	Length of Stay	Average hospital length of stay in days	0 days, 3 days, 5 days and 14 days post-operation	Yes
Secondary	Hospital Cost Per Patient	Average hospital irrigant cost per patient	Volume used from admission to discharge	No