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The purpose of this study is to evaluate the effectiveness of dHACM in reducing scar tissue formation in craniectomy patients as well as facilitating reoperation and repair. Specifically this study compares craniectomy without dHACM application to craniectomy with placement of dHACM between the galea and dura over dural suture line and/or exposed parenchyma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Control | Other | Will receive only traditional craniectomy |
|
| Group 2 Treatment dHACM | Experimental | Will receive craniectomy, but with the addition of a piece of dHACM placed over any dural defect or dural closure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dHACM | Other | A piece of dHACM placed over any dural defect or dural closure during craniectomy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of scarring between the galea and the dura, as assessed by the Ease of Dissection (EOD) Score and histological analysis upon reoperation in patients receiving craniectomy with durotomy. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Intra- and post-operative complications at reoperation, as assessed by occurrence of violation of the dura and/or violation of the parenchyma. | 6 Months | |
| Post-operative complications at original and re-operation | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chris Clare, MD | MiMedx Group, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boulder Neurological Associates | Boulder | Colorado | 80303 | United States | ||
| Chattanooga Center for Neurological Research |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003399 | Craniotomy |
| D056424 | Decompressive Craniectomy |
| ID | Term |
|---|---|
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019299 | Decompression, Surgical |
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| Craniectomy | Procedure | Removal of the skull flap followed by closure techniques per current SOC. |
|
|
| Peri-operative measures at original and re-operation | 6 Months |
| Survival | 6 Months |
| Chattanooga |
| Tennessee |
| 37403 |
| United States |