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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Withdrawn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

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 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

NCT ID

NCT03875833

First Posted

March 13, 2019

Last Updated

May 18, 2023

Sponsor

The University of Texas Health Science Center, Houston

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

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

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

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

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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