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The purpose of this study is to determine the impact of an autologous umbilical cord patch for dural closure on the repair of open neural tube defect. The outcomes will evaluate successful defect closure, creation of a more capacious spinal canal, and reduction in inflammatory tissue response versus historical controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous umbilical cord patch | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous umbilical cord patch | Procedure | Surgery will occur from birth to 24 hours of age. The autologous umbilical cord patch is harvested at time of delivery and immediately processed in a sterile setting in order to create a dural patch as a spinal cord cover to close the developmental defect within a few hours after birth. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that have wound dehiscence | one-month post-op | |
| Number of participants that have wound dehiscence | 1-year post-op | |
| Number of participants that have Cerebrospinal fluid (CSF) leakage | one-month post-op | |
| Number of participants that have CSF leakage | 1-year post-op. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that present with tethered cord syndrome | one-month post-op,12-months post-op, 30-months post-op, and 60-months post-op | |
| Number of participants that had a change in level of neurological function as assessed by the American Spinal Injury Association Impairment Scale (ASIA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephen Fletcher, DO | Contact | (713) 500-7308 | Stephen.Fletcher@uth.tmc.edu | |
| Caroline Doughty | Contact | 713-500-7481 | Caroline.Doughty@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Stephen Fletcher, DO | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
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| ID | Term |
|---|---|
| D016135 | Spinal Dysraphism |
| D008591 | Meningomyelocele |
| ID | Term |
|---|---|
| D009436 | Neural Tube Defects |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D000013 | Congenital Abnormalities |
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|
| baseline, one-month post-op,12-months post-op |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |