Radial Forearm Versus the Ulnar Forearm Free Flap

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2023-08-15

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.

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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.

Conditions

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Free Tissue Flaps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects are assigned to one of two treatment arms

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

To the extend possible based on the nature of the study, subjects and researchers will be masked from the treatment arms.

Study Groups

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Radial forearm free flap

Subjects in this arm will receive a radial forearm free flap.

Group Type ACTIVE_COMPARATOR

Radial Forearm Free Flap

Intervention Type PROCEDURE

Subjects in this arm will undergo a radial forearm free flap.

Ulnar forearm free flap

Subjects in this arm will receive an ulnar forearm free flap.

Group Type ACTIVE_COMPARATOR

Ulnar Forearm Free Flap

Intervention Type PROCEDURE

Subjects in this arm will undergo an ulnar forearm free flap.

Interventions

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Radial Forearm Free Flap

Subjects in this arm will undergo a radial forearm free flap.

Intervention Type PROCEDURE

Ulnar Forearm Free Flap

Subjects in this arm will undergo an ulnar forearm free flap.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No