Radial Forearm Versus the Ulnar Forearm Free Flap

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

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.

Study Overview

• Status: Terminated
• Conditions: Free Tissue Flaps
• Intervention / Treatment: Procedure: Radial Forearm Free Flap; Procedure: Ulnar Forearm Free Flap

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.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Eskenazi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Indiana University
• Investigators: Principal Investigator: Joshua Adkinson, M.D., Indiana University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): July 15, 2023
• Study Completion (Actual): August 15, 2023

Study Registration Dates

• First Submitted: January 24, 2018
• First Submitted That Met QC Criteria: June 25, 2018
• First Posted (Actual): July 6, 2018

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Free Tissue Transfer; Radial Forearm Free Flap; Ulnar Forearm Free Flap
• Other Study ID Numbers: 1712593520

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No