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| ID | Type | Description | Link |
|---|---|---|---|
| 1200-0007 |
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| Name | Class |
|---|---|
| PuriCore, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vashe | Device | Antimicrobial irrigant |
| |
| Mafenide acetate |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay | Average hospital length of stay in days | 0 days, 3 days, 5 days and 14 days post-operation |
| Hospital Cost Per Patient | Average hospital irrigant cost per patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Foster, MD | District Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maricopa Integrated Health System | Phoenix | Arizona | 85008 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 5% Mafenide Acetate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Length of Stay | Average hospital length of stay in days | Per protocol | Posted | Mean | Standard Deviation | Days | 0 days, 3 days, 5 days and 14 days post-operation |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MRSA infection | Infections and infestations | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematological abnormality | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Richey, RN | Maricopa Integrated Health System | 602-344-5125 | karen.richey@mihs.org |
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| ID | Term |
|---|---|
| D002056 | Burns |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D008272 | Mafenide |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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| Drug |
Antimicrobial solution |
|
| Volume used from admission to discharge |
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Hospital Cost Per Patient | Average hospital irrigant cost per patient | Per protocol | Posted | Mean | Standard Deviation | Dollars | Volume used from admission to discharge |
|
|
|
| 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 | Per protocol | Posted | Mean | Standard Deviation | Percentage area | 14 days |
|
|
|
| 2 |
| 11 |
| 11 |
| 11 |
| EG001 | 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. | 1 | 8 | 8 | 8 |
| Proteinuria | Renal and urinary disorders | Systematic Assessment |
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| Cellulitis | Infections and infestations | Systematic Assessment |
|
| Chemistry abnormality | Blood and lymphatic system disorders | Systematic Assessment |
|
| Urinalysis abnormality | Renal and urinary disorders | Systematic Assessment |
|
| UTI | Renal and urinary disorders | Systematic Assessment |
|
| Vaginitis | Reproductive system and breast disorders | Systematic Assessment |
|
| Possible seizure | Nervous system disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
|
| Change in affect | Psychiatric disorders | Systematic Assessment |
|
| Coagulation abnormalities | Blood and lymphatic system disorders | Systematic Assessment |
|
| Acute pain | Injury, poisoning and procedural complications | Systematic Assessment |
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| Chronic pain | Injury, poisoning and procedural complications | Systematic Assessment |
|
| MRSA infection | Infections and infestations | Systematic Assessment |
|
| Staph infection | Infections and infestations | Systematic Assessment | Not at test site |
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| Cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Surgical site drainage | Infections and infestations | Systematic Assessment | Not in test area |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Fever | Metabolism and nutrition disorders | Systematic Assessment |
|
| Chest pain | Cardiac disorders | Systematic Assessment |
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| Edema | Blood and lymphatic system disorders | Systematic Assessment | Not at test site |
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| Bronchospasm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Desaturation | Injury, poisoning and procedural complications | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Hypertrophic granulation tissue | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |