Dysesthesia, Head and Neck Neoplasms
Conditions
Brief summary
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.
Interventions
DEVICECollagen Nerve Wrap Conduit
The collagen nerve wrap conduit will be placed on all exposed radial and ulnar nerves at the time of free flap harvest.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 objective clinical findings | baseline | Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported. |
Outcome results
None listed