Not provided
Not provided
Not provided
Not provided
Not provided
Investigators no longer interested in pursuing
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Acera Surgical, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Adult patients undergoing a radial forearm free flap or ulnar forearm free flap will be randomized to the use of the Restrata graft in combination with split-thickness skin graft for reconstruction. Photos will document whether the Restata graft aids in the healing.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A - Standard of Care | Active Comparator |
| |
| B - Restrata Graft | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Restrata Graft | Device | Restrata will be meshed in a 1:2 fashion to allow for egress of serous fluid and minimize risk of fluid collection. Restrata will be applied to the entire wound bed not amenable to primary closure and will be underlaid beneath the surrounding skin edges. A split-thickness skin graft is harvested from patient's thigh at 15:1000 inches and placed on top of the Restrata to cover the entire wound bed. The graft is sutured in place using suture choice of surgeon's preference. |
| Measure | Description | Time Frame |
|---|---|---|
| Tendon exposure | Tendon exposure at four weeks post-operatively (Yes/No). | 4 weeks post-operation |
| Percentage of surface area | Percentage of surface area of split-thickness skin graft incorporation at four weeks postoperatively. | 4 weeks post operation |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert Lindau, MD | Nebraska Methodist Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Standard of Care Skin Graft | Procedure | Standard of Care Skin Graft |
|