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 range18 Years – 120 Years

SexALL

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

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

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