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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

NCT03875833 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-05-22

No results posted yet for this study

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.

Conditions

  • Head and Neck Neoplasms
  • Dysesthesia

Interventions

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.

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • James C Melville, DDS · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-09
Primary Completion
2024-01-01
Completion
2024-01-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03875833 on ClinicalTrials.gov