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 System (UT)

Status: Withdrawn

Conditions: Head and Neck Neoplasms; Dysesthesia

Treatments: Device: Collagen Nerve Wrap Conduit

Study type: Interventional

Funder types: Other

Identifiers

NCT03875833

HSC-DB-18-0760

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Collagen Nerve Wrap Conduit

Experimental group

Treatment:

Device: Collagen Nerve Wrap Conduit

Control

No Intervention group