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

The University of Texas Health Science Center, Houston

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Head and Neck Neoplasms Dysesthesia

Interventions

Collagen Nerve Wrap ConduitDEVICE

The collagen nerve wrap conduit will be placed on all exposed radial and ulnar nerves at the time of free flap harvest.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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