NCT00586729

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 4, 2008

Completed
1.5 years until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

September 10, 2012

Completed
Last Updated

September 14, 2012

Status Verified

September 1, 2012

Enrollment Period

1.3 years

First QC Date

December 21, 2007

Results QC Date

August 9, 2012

Last Update Submit

September 7, 2012

Conditions

Burns

Keywords

BurnBurn wound managementBurn graft

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Length of Stay

    0 days, 3 days, 5 days and 14 days post-operation

  • Hospital Cost Per Patient

    Volume used from admission to discharge

Study Arms (2)

Vashe

EXPERIMENTAL

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.

Device: Vashe

5% Mafenide Acetate

ACTIVE COMPARATOR

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.

Drug: Mafenide acetate

Interventions

VasheDEVICE

Antimicrobial irrigant

Vashe
Mafenide acetateDRUG

Antimicrobial solution

5% Mafenide Acetate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maricopa Integrated Health System

Phoenix, Arizona, 85008, United States

Location

MeSH Terms

Conditions

Burns

Interventions

Mafenide

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur Compounds

Results Point of Contact

Title
Karen Richey, RN
Organization
Maricopa Integrated Health System
karen.richey@mihs.org
602-344-5125

Study Officials

  • Kevin Foster, MD

    District Medical Group

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 4, 2008

Study Start

July 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

September 14, 2012

Results First Posted

September 10, 2012

Record last verified: 2012-09

Locations

US(1)