WithdrawnNot Applicable

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

Stopped: Lack of enrollment

0Started 2020-10-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

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

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

Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings

Timeframe: baseline

Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings

Trial details

NCT IDNCT03875833

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-01

View on ClinicalTrials.gov More Head and Neck Neoplasms trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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

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

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

Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings

Timeframe: baseline

Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings