Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy of the Spiracur SNaP® Wound Care System for the treatment of acute trauma and acute surgical excision wounds. The secondary purpose will be to compare the prospective patients to retrospectively treated acute trauma wounds to further evaluate efficacy and safety.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SNaP® Wound Care System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNaP® Wound Care System | Device | Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Wound Closure | Percent of subjects with study wound deemed closed at 12 weeks 1 wound is studied per participant | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Wound Size Change | Percent change in wound size from baseline to week 4 (Week 4 - baseline / baseline) | Baseline and 4 weeks |
| Percent Wound Size Change | Percent change in wound size from week 4 to week 8 (Week 8 - Week 4 / Week 4) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Study population will be selected from exisiting investigator patient population.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 41955 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SNaP® Wound Care System | SNaP® Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SNaP® Wound Care System | SNaP® Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| 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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Wound Closure | Percent of subjects with study wound deemed closed at 12 weeks 1 wound is studied per participant | Per protocol population used for analysis. 3 subjects withdrew from study early due to non-compliance with study therapy and were not included in this analysis. | Posted | Count of Participants | Participants | 12 weeks |
|
|
12 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SNaP® Wound Care System | SNaP® Wound Care System: Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Global Clinical Development | KCI | 12102555595 | jane.hart@acelity.com |
Not provided
| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
Not provided
Not provided
Not provided
Not provided
Not provided
| 4 weeks and 8 weeks |
| Percent Wound Size Change | Percent change in wound size from week 8 to week 12 (12 Weeks - 8 weeks / 8 weeks) | 8 weeks and 12 weeks |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Percent Wound Size Change | Percent change in wound size from baseline to week 4 (Week 4 - baseline / baseline) | Posted | Mean | Standard Deviation | percent change | Baseline and 4 weeks |
|
|
|
| Secondary | Percent Wound Size Change | Percent change in wound size from week 4 to week 8 (Week 8 - Week 4 / Week 4) | Posted | Mean | Standard Deviation | percent change | 4 weeks and 8 weeks |
|
|
|
| Secondary | Percent Wound Size Change | Percent change in wound size from week 8 to week 12 (12 Weeks - 8 weeks / 8 weeks) | Posted | Mean | Standard Deviation | percent change | 8 weeks and 12 weeks |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
Not provided
Not provided