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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

Primary Purpose

Head and Neck Neoplasms, Dysesthesia

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Collagen Nerve Wrap Conduit
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Collagen Nerve Wrap Conduit

    Control

    Arm Description

    Outcomes

    Primary Outcome Measures

    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
    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
    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
    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
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 13, 2019
    Last Updated
    May 18, 2023
    Sponsor
    The University of Texas Health Science Center, Houston
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03875833
    Brief Title
    Prospective Analysis of Effect of Collagen Wrap Conduit on Radial and Ulnar Nerve Function Following Radial/Ulnar Forearm Free Flap Harvest
    Official Title
    Prospective Analysis of Effect of Collagen Wrap Conduit on Radial and Ulnar Nerve Function Following Radial/Ulnar Forearm Free Flap Harvest
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Lack of enrollment
    Study Start Date
    October 9, 2020 (Actual)
    Primary Completion Date
    January 1, 2024 (Anticipated)
    Study Completion Date
    January 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The University of Texas Health Science Center, Houston

    4. Oversight

    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

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head and Neck Neoplasms, Dysesthesia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Collagen Nerve Wrap Conduit
    Arm Type
    Experimental
    Arm Title
    Control
    Arm Type
    No Intervention
    Intervention Type
    Device
    Intervention Name(s)
    Collagen Nerve Wrap Conduit
    Intervention Description
    The collagen nerve wrap conduit will be placed on all exposed radial and ulnar nerves at the time of free flap harvest.
    Primary Outcome Measure Information:
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings
    Description
    Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported.
    Time Frame
    baseline
    Title
    Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings
    Description
    Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported.
    Time Frame
    3 months
    Title
    Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings
    Description
    Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported.
    Time Frame
    6 months
    Title
    Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings
    Description
    Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    James C Melville, DDS
    Organizational Affiliation
    The University of Texas Health Science Center, Houston
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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