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Withdrawn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
About this trial
This is an interventional treatment trial for Head and Neck Neoplasms
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
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
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
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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