Clinical trial NCT03875833: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Head and Neck Neoplasms
Dysesthesia
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: baseline
measure: 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
timeFrame: 3 months
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 12 months
measure: Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings
timeFrame: baseline
measure: Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings
timeFrame: 3 months
measure: Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings
timeFrame: 6 months
measure: Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: James C Melville, DDS
role: PRINCIPAL_INVESTIGATOR
References: