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

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 Overview

• Status: Withdrawn
• Conditions: Head and Neck Neoplasms; Dysesthesia
• Intervention / Treatment: Device: Collagen Nerve Wrap Conduit

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James C Melville, DDS; Phone Number: 713-500-7831; Email: James.C.Melville@uth.tmc.edu
• Study Contact Backup: Name: Simon W Young, DDS; Phone Number: 713-486-4253; Email: Simon.Young@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: James C Melville, DDS; Phone Number: 713-500-7831; Email: James.C.Melville@uth.tmc.edu
      • Contact: Simon W Young, DDS; Phone Number: 713-486-4253; Email: Simon.Young@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Collagen Nerve Wrap Conduit	Device: Collagen 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: James C Melville, DDS, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2020
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: March 13, 2019
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Neoplasms by Site; Neurologic Manifestations; Sensation Disorders; Somatosensory Disorders; Head and Neck Neoplasms; Paresthesia
• Other Study ID Numbers: HSC-DB-18-0760

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No