BurnsNCT00586729
Vashe Wound Therapy Study
A study testing Vashe and Mafenide acetate in people with Burns, run by Valleywise Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Vashe and Mafenide acetate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Nov 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Maricopa Integrated Health System
Phoenix, Arizona, 85008
About this study
Official title: Pilot Study to Evaluate Effectiveness of Vashe™ Wound Therapy as an Antimicrobial Irrigant in Burn Wound Management
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.
- Conditions
- Burns
- Being tested
- Vashe, Mafenide acetate
- Keywords
- Burn, Burn wound management, Burn graft
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VasheDevice
Antimicrobial irrigant
Mafenide acetateDrug
Antimicrobial solution
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Mafenide acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days
Secondary outcomes (2)
Length of Stay
Average hospital length of stay in days
Measured: 0 days, 3 days, 5 days and 14 days post-operation
Hospital Cost Per Patient
Average hospital irrigant cost per patient
Measured: Volume used from admission to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startJul 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Valleywise Health
- Sponsor type
- University, hospital or other
- Collaborators
- PuriCore, Inc.
- Responsible party
- Sponsor
- Investigators
- Kevin Foster, MD, Principal investigator, District Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586729
- Sponsor's protocol ID
- 2007-012
- Other IDs
- 1200-0007
- Status last verified
- Sep 2012
- First submitted
- 21 Dec 2007
- Last updated
- 14 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate Effectiveness of Vashe™ Wound Therapy as an Antimicrobial Irrigant in Burn Wound Management
- ClinicalTrials.gov ID
- NCT00586729
- Acronym / sponsor ID
- 2007-012
- Conditions
- Burns
- Keywords
- Burn, Burn wound management, Burn graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Valleywise HealthUniversity, hospital or other
- Collaborators
- PuriCore, Inc.
- Study start
- Jul 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 4 Jan 2008 (estimated)
- Results
- Posted 10 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vashe | Experimental | Device: VasheVashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days. |
| 5% Mafenide Acetate | Active comparator | Drug: Mafenide acetate5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VasheAntimicrobial irrigant | Device | Vashe |
| Mafenide acetateAntimicrobial solution | Drug | 5% Mafenide Acetate |
Primary outcome
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
2 secondary outcomes
Length of Stay
Time frame: 0 days, 3 days, 5 days and 14 days post-operation
Hospital Cost Per Patient
Time frame: Volume used from admission to discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Foster, MD principal investigator
District Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vashe and Mafenide acetate in people with Burns, run by Valleywise Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Grafted Area That is Viable at Day 14 (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2012.