NCT03875833

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2020

Typical duration for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 9, 2020

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

May 22, 2023

Status Verified

May 1, 2023

Enrollment Period

3.2 years

First QC Date

March 13, 2019

Last Update Submit

May 18, 2023

Conditions

Head and Neck NeoplasmsDysesthesia

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (2)

Collagen Nerve Wrap Conduit

EXPERIMENTAL
Device: Collagen Nerve Wrap Conduit

Control

NO INTERVENTION

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.

Collagen Nerve Wrap Conduit

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • pre-existing nerve deficits
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Head and Neck NeoplasmsParesthesia

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSomatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • James C Melville, DDS

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 15, 2019

Study Start

October 9, 2020

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

May 22, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share