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The purpose of this study is to determine whether collagen nerve conduits placed on exposed radial and ulnar nerves during radial and ulnar forearm free flap harvests will reduce the occurrence and degree of sensory nerve deficit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collagen Nerve Wrap Conduit | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagen Nerve Wrap Conduit | Device | The collagen nerve wrap conduit will be placed on all exposed radial and ulnar nerves at the time of free flap harvest. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with normal sensory recovery at the site of forearm free flap as assessed by subjective patient questionnaire regarding upper extremity sensation and function | baseline | |
| Number of participants with normal sensory recovery at the site of forearm free flap as assessed by subjective patient questionnaire regarding upper extremity sensation and function | 3 months | |
| Number of participants with normal sensory recovery at the site of forearm free flap as assessed by subjective patient questionnaire regarding upper extremity sensation and function | 6 months | |
| Number of participants with normal sensory recovery at the site of forearm free flap as assessed by subjective patient questionnaire regarding upper extremity sensation and function | 12 months | |
| Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings | Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported. | baseline |
| Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings | Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported. | 3 months |
| Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James C Melville, DDS | The University of Texas Health Science Center, Houston | Principal Investigator |
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Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported.
| 6 months |
| Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings | Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported. | 12 months |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D010292 | Paresthesia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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