TerminatedNot Applicable

Radial Forearm Versus the Ulnar Forearm Free Flap

Stopped: inadequate enrollment

United States24 participantsStarted 2018-01-01

Plain-language summary

This study evaluates donor site outcomes in patients receiving radial forearm free flap reconstruction versus ulnar forearm free flap reconstruction. Patients who meet criteria for forearm free flap reconstruction are randomized to receiving either radial forearm free flap or ulnar forearm free flap reconstruction.

Who can participate

Age range

18 Years – 120 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 with planned forearm free flap reconstruction * Patients who are deemed equal surgical candidates for radial forearm free flap and ulnar forearm free flap reconstruction * Preoperative Allen's test completed and passed * Patients have the capacity to complete the informed consent process Exclusion Criteria: * Patients that are not candidates for a forearm flap based on their physiology * Clinically evident peripheral neuropathy (e.g., diabetic neuropathy, leprosy) * Patients requiring concurrent forearm bone for reconstruction * Child, prisoner, or other vulnerable group

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

Average Grip Strength (lbs) in the operative hand and non-operative hand

Timeframe: up to 6 months

Average Key Pinch Strength (lbs) in the operative hand and non-operative hand

Timeframe: up to 6 months

Average Physician and Patient Rating of Scar Appearance

Timeframe: up to 6 months

Aggregated Brief Michigan Hand Questionnaire results (composite score)

Timeframe: up to 6 months

Average Static Two Point Discrimination (mm)

Timeframe: up to 6 months

Trial details

NCT IDNCT03579277

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-07-15

View on ClinicalTrials.gov More Free Tissue Flaps trials

Plain-language summary

Who can participate

Age range

18 Years – 120 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

Average Grip Strength (lbs) in the operative hand and non-operative hand

Timeframe: up to 6 months

Average Key Pinch Strength (lbs) in the operative hand and non-operative hand

Timeframe: up to 6 months

Average Physician and Patient Rating of Scar Appearance

Timeframe: up to 6 months

Aggregated Brief Michigan Hand Questionnaire results (composite score)

Timeframe: up to 6 months

Average Static Two Point Discrimination (mm)

Timeframe: up to 6 months