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

Sponsor

The University of Texas Health Science Center, Houston (Other)

Overall Status

Recruiting

CT.gov ID

NCT03875833

Collaborator

(none)

Enrollment

Location

Arms

25.7

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Neoplasms Dysesthesia	Device: Collagen Nerve Wrap Conduit	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 9, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.
No Intervention: Control

Arm

Intervention/Treatment

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.

No Intervention: Control

Outcome Measures

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 [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 [baseline]
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 [3 months]
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 [6 months]
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 [12 months]
Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Texas Health Science Center at Houston	Houston	Texas	United States	77030

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

James C Melville, Assistant Professor, The University of Texas Health Science Center, Houston

ClinicalTrials.gov Identifier:

NCT03875833

Other Study ID Numbers:

HSC-DB-18-0760

First Posted:

Mar 15, 2019

Last Update Posted:

Dec 8, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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.:

Additional relevant MeSH terms:

Head and Neck Neoplasms

Paresthesia

Study Results

No Results Posted as of Dec 8, 2020