Radial Forearm Versus the Ulnar Forearm Free Flap

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Functional Outcomes and Morbidity of the Radial Forearm Versus the Ulnar Forearm Free Flap: A Prospective, Randomized Trial

Conditions
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Free Tissue Flaps

Intervention / Treatment
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* Procedure: Radial Forearm Free Flap
* Procedure: Ulnar Forearm Free Flap


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects are assigned to one of two treatment arms
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radial forearm free flap<br>Subjects in this arm will receive a radial forearm free flap. | Procedure: Radial Forearm Free Flap<br>* Subjects in this arm will undergo a radial forearm free flap.<br>|
| Active Comparator: Ulnar forearm free flap<br>Subjects in this arm will receive an ulnar forearm free flap. | Procedure: Ulnar Forearm Free Flap<br>* Subjects in this arm will undergo an ulnar forearm free flap.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Grip Strength (lbs) in the operative hand and non-operative hand | 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. | up to 6 months | 
| Average Key Pinch Strength (lbs) in the operative hand and non-operative hand | 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. | up to 6 months | 
| Average Physician and Patient Rating of Scar Appearance | Subject's and physician's reported assessment of scar appearance on a Likert scale up to 10. | up to 6 months | 
| Aggregated Brief Michigan Hand Questionnaire results (composite score) | Subjects' reported outcomes of hand function, as measured by the brief Michigan Hand Questionnaire survey results, on a scale up to 100. | up to 6 months | 
| Average Static Two Point Discrimination (mm) | 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. | up to 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radial Forearm Free Flap, Ulnar Forearm Free Flap, Free Tissue Transfer