MedDataX Logo

Vashe Wound Therapy Study

NCT ID: NCT00586729

Last Updated: 2012-09-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Burns

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Burn Burn wound management Burn graft

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Vashe

Antimicrobial irrigant

Intervention Type DEVICE

Mafenide acetate

Antimicrobial solution

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

PuriCore, Inc.

INDUSTRY

Sponsor Role collaborator

Valleywise Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kevin Foster, MD

Role: PRINCIPAL_INVESTIGATOR

District Medical Group

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Maricopa Integrated Health System

Phoenix, Arizona, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1200-0007

Identifier Type: -

Identifier Source: secondary_id

2007-012

Identifier Type: -

Identifier Source: org_study_id