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

Head and Neck Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03875833
• Other study ID #: HSC-DB-18-0760
• Status: Withdrawn
• Phase: N/A
• Start date: October 9, 2020
• Est. completion date: January 1, 2024

Study information

• Verified date: May 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dysesthesia
• Head and Neck Neoplasms
• Paresthesia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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