Burns
Conditions
Keywords
Burn, Burn wound management, Burn graft
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.
Interventions
DEVICEVashe
Antimicrobial irrigant
DRUGMafenide acetate
Antimicrobial solution
Sponsors
PuriCore, Inc.
Valleywise Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Grafted Area That is Viable at Day 14 | 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
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | 0 days, 3 days, 5 days and 14 days post-operation | Average hospital length of stay in days |
| Hospital Cost Per Patient | Volume used from admission to discharge | Average hospital irrigant cost per patient |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 14 |
| 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. | 9 |
| Total | 23 |
Baseline characteristics
| Characteristic | 5% Mafenide Acetate | Vashe | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical >=65 years | 2 Participants | 3 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 10 Participants | 17 Participants |
| Age Continuous | 52.7 years STANDARD_DEVIATION 16.1 | 47.0 years STANDARD_DEVIATION 17.9 | 47.6 years STANDARD_DEVIATION 17.8 |
| Region of Enrollment United States | 9 participants | 14 participants | 23 participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 6 Participants | 10 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 11 / 11 | 8 / 8 |
| serious Total, serious adverse events | 2 / 11 | 1 / 8 |
Outcome results
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
Time frame: 14 days
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vashe | Percentage of Grafted Area That is Viable at Day 14 | 96.3 Percentage area | Standard Deviation 7.05 |
| 5% Mafenide Acetate | Percentage of Grafted Area That is Viable at Day 14 | 96.0 Percentage area | Standard Deviation 3.83 |
Secondary
Hospital Cost Per Patient
Average hospital irrigant cost per patient
Time frame: Volume used from admission to discharge
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vashe | Hospital Cost Per Patient | 249.38 Dollars | Standard Deviation 93.43 |
| 5% Mafenide Acetate | Hospital Cost Per Patient | 393.00 Dollars | Standard Deviation 176.94 |
Secondary
Length of Stay
Average hospital length of stay in days
Time frame: 0 days, 3 days, 5 days and 14 days post-operation
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vashe | Length of Stay | 21.5 Days | Standard Deviation 4.2 |
| 5% Mafenide Acetate | Length of Stay | 15.6 Days | Standard Deviation 5.1 |