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| Name | Class |
|---|---|
| Kinetic Concepts, Inc. | INDUSTRY |
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This is multi-center prospective, longitudinal case series with comparison to historical controls.
The primary objective to this study is to determine the effectiveness of CelluTomeâ„¢ epidermal harvesting system as an outpatient skin grafting system for selected patients versus inpatient skin graft harvest. This is multi-center prospective, longitudinal case series with comparison to historical controls. In this study, all subjects will receive the same treatment protocol regardless of institution. This will include routine wound photography. Ongoing healing process will be recorded and reviewed. The secondary objectives of this study are to establish an ideal donor site size, recipient site size and ideal patient population (especially high operative risk patients) that would benefit from the use of CelluTomeâ„¢ Epidermal Harvesting System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Split Thickness Skin Graft Harvest | Active Comparator | Retrospective review |
|
| Cellutome Epidermal Harvesting System | Experimental | Prospective patients will receive a skin graft utilizing the Cellutome Epidermal Harvesting System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cellutome Epidermal Harvesting System | Device | Cellutome Epidermal Harvesting System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Healing Time | Healing time is defined as the required time for the graft site to become dry enough for removal of the dressing without further discharge from the wound AND 100% re-epithelialization has occurred | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Healing at Donor Site | Photography and physician examination with determination | 8 weeks |
| Scarring | Areas of donor site which heal with excess scar tissue and recipient site which heal due to secondary intention (epithelization without skin grafting application). Photography and physician examination with determination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Noman A Siddiqui, DPM, MHA | Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health | Baltimore | Maryland | 21215 | United States |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Split Thickness Skin Graft | Procedure | Split Thickness Skin Graft |
|
| 8 weeks |
| Complications | Cellulitis involving the donor or recipient site, infection involving continuous drainage, abscess formation, erythema, edema, pruritus and fever. Physician determination of complications post procedure. | 8 weeks |