Radial Forearm Versus the Ulnar Forearm Free Flap

Free Tissue Flaps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03579277
• Other study ID #: 1712593520
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: August 15, 2023

Study information

• Verified date: August 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: August 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Free Tissue Flaps

Intervention

Procedure:
• Radial Forearm Free Flap
Subjects in this arm will undergo a radial forearm free flap.
• Ulnar Forearm Free Flap
Subjects in this arm will undergo an ulnar forearm free flap.

Locations

Country	Name	City	State
United States	Eskenazi Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Number of patients with complete flap loss	Number of patients with complete flap loss as assessed by chart review.	up to 6 months
Secondary	Number of patients with partial flap loss	Number of patients with partial flap loss as assessed by chart review.	up to 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of patients experiencing mortality	Number of patients experiencing mortality, as assessed by chart review.	up to 6 months
Secondary	Number of patients with donor site dehiscence	Number of patients with donor site dehiscence, as assessed by chart review	up to 6 months
Secondary	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
Secondary	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