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| Name | Class |
|---|---|
| Georgetown University | OTHER |
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This is a retrospective, multi-center study evaluating the outcomes of using Integra® skin sheet bilayer or single layer products for complex soft tissue reconstruction of lower extremity diabetic wounds compared to other treatments. Participating sites will collect information for all patients who received Integra, free flap, local tissue flap, or negative pressure therapy over a 5 year period. The patient must be a minimum of 1 year from index procedure, with index procedure being defined as the application of Integra, free flap, local tissue flap, or negative pressure. Any follow-up occurring during the year is eligible for inclusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Integra | |||
| Integra + NPWT (short-inpatient use only) | |||
| Integra + NPWT (long-all other durations) | |||
| Integra + STSG | |||
| Integra + Dermoinductive Agent | |||
| Free Flap | |||
| Local Tissue Flap | |||
| NPWT | |||
| NPWT then Integra (on same admission) |
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| Measure | Description | Time Frame |
|---|---|---|
| Wound recurrence rates after Integra application (and final split-thickness skin graft or dermoinductive agent application) as compared with free flap, local tissue flap, and negative pressure wound therapy. | A dermoinductive agent is a product that is said to promote rapid wound healing. | 5 year period |
| Measure | Description | Time Frame |
|---|---|---|
| Time to ambulation/return to function after Integra application, free flap, local tissue flap, or negative pressure wound therapy. | 5 year period |
| Measure | Description | Time Frame |
|---|---|---|
| Time to wound bed preparation for receipt of a split thickness skin graft (STSG) or dermoinductive agent after having received Integra or negative pressure wound therapy | 5 years | |
| Time to complete re-epithelization (as deemed by the surgeon) after Integra application or NPWT |
Inclusion Criteria:
Exclusion Criteria:
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All patients who received Integra, free flap, local tissue flap, or negative pressure wound therapy over a 5-year period. The patient must be a minimum of 1 year from the index procedure, any follow-up occurring during the year is eligible for inclusion.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Hospital Wound Healing Center | Washington D.C. | District of Columbia | 20007 | United States | ||
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| 5 years |
| Northwestern University Feinberg School of Medicine Division of Plastic Surgery |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Brigham and Women's Hospital, Inc | Boston | Massachusetts | 02115 | United States |
| University of Texas Southwestern Medical Ceter | Dallas | Texas | 75390 | United States |