Radial Forearm Versus the Ulnar Forearm Free Flap

Not Applicable

Terminated

• Conditions: Free Tissue Flaps
• Interventions: Procedure: Radial Forearm Free Flap; Procedure: Ulnar Forearm Free Flap

• Registration Number: NCT03579277
• Lead Sponsor: Indiana University

Brief 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.

Detailed Description

The radial forearm free flap and the ulnar forearm free flap are both well-described procedures used for free tissue transfer in reconstructive surgery. Although forearm free flaps are frequently performed, there is insufficient prospective data looking at the morbidity of the radial compared to ulnar forearm free flaps. The goal of this research study is to characterize the outcomes for each of these two flaps, and to determine if there is surgical equipoise, or if one flap is better than the other.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-06-25
• Study First Posted: 2018-07-06
• Primary Completion: 2023-07-15
• Status Verified: 2023-08
• Study Completion: 2023-08-15
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radial forearm free flap	Radial Forearm Free Flap	Subjects in this arm will receive a radial forearm free flap.
Ulnar forearm free flap	Ulnar Forearm Free Flap	Subjects in this arm will receive an ulnar forearm free flap.

Primary Outcome Measures

Name	Time	Method
Average Static Two Point Discrimination (mm)	up to 6 months	Subjects' static two point discrimination threshold in their finger pads, palm, and dorsum of the hand, in the operative and non-operative extremity, each measured in millimeters.
Average Key Pinch Strength (lbs) in the operative hand and non-operative hand	up to 6 months	Subjects' pinch strength in their operative hand and non-operative hand, each measured as the maximum amount of force applied with key pinch in pounds.
Average Physician and Patient Rating of Scar Appearance	up to 6 months	Subject's and physician's reported assessment of scar appearance on a Likert scale up to 10.
Average Grip Strength (lbs) in the operative hand and non-operative hand	up to 6 months	Subjects' grip strength in their operative hand and non-operative hand, each measured as the maximum amount of force applied by the hand to a Jamar Dynometer in pounds.
Aggregated Brief Michigan Hand Questionnaire results (composite score)	up to 6 months	Subjects' reported outcomes of hand function, as measured by the brief Michigan Hand Questionnaire survey results, on a scale up to 100.

Secondary Outcome Measures

Name	Time	Method
Number of patients with complete flap loss	up to 6 months	Number of patients with complete flap loss as assessed by chart review.
Number of patients with partial flap loss	up to 6 months	Number of patients with partial flap loss as assessed by chart review.
Number of patients reporting cold intolerance	up to 6 months	Number of patients reporting cold intolerance in the operative and non-operative extremity as assessed by patient's response to questioning them about feeling cold intolerance.
Number of patients with partial skin graft non-take	up to 6 months	Number of patients with partial skin graft non-take, as assessed by chart review
Number of patients with postoperative hematoma at donor site	up to 6 months	Number of patients with postoperative hematoma at donor site, as assessed by chart review.
Number of patients experiencing mortality	up to 6 months	Number of patients experiencing mortality, as assessed by chart review.
Number of patients with donor site dehiscence	up to 6 months	Number of patients with donor site dehiscence, as assessed by chart review
Number of patients with complete skin graft non-take	up to 6 months	Number of patients with complete skin graft non-take, as assessed by chart review
Number of patients with postoperative hematoma at recipient site	up to 6 months	Number of patient with postoperative hematoma at recipient site, as assessed by chart review
Number of patient with postoperative infection at recipient site	up to 6 months	Number of patient with postoperative infection at recipient site, as assessed by chart review.
Number of patients reporting neuropathy	up to 6 months	Number of patients reporting cold intolerance as assessed by patient's response to questioning them about feeling neuropathy
Number of patients with postoperative cellulitis at donor site	up to 6 months	Number of patients with postoperative cellulitis at donor site as assessed by chart review.

Trial Locations

Locations (1)

Eskenazi Hospital; 🇺🇸 Indianapolis, Indiana, United States