Prospective Analysis of Effect of Collagen Wrap Conduit on Radial and Ulnar Nerve Function Following Radial/Ulnar Forearm Free Flap Harvest

Study Overview
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Brief Summary
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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.

Official Title
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Prospective Analysis of Effect of Collagen Wrap Conduit on Radial and Ulnar Nerve Function Following Radial/Ulnar Forearm Free Flap Harvest

Conditions
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Head and Neck Neoplasms, Dysesthesia

Intervention / Treatment
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* Device: Collagen Nerve Wrap Conduit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients present with a complex defect after tumor resection all these cases done with the departments of Oral and Maxillofacial Surgery and Otolaryngology at the University of Texas in multiple locations that include, Memorial Hermann Hospital, Ben Taub General Hospital, Lyndon B. Johnson General Hospital and The Methodist hospital. patients that have been diagnosed with head and neck tumors and who will undergo a composite resection and reconstruction with radial or ulnar free vascularized flap. Exclusion Criteria: pre-existing nerve deficits pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collagen Nerve Wrap Conduit<br> | Device: Collagen Nerve Wrap Conduit<br>* The collagen nerve wrap conduit will be placed on all exposed radial and ulnar nerves at the time of free flap harvest.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 |