Clinical trial NCT03579277: Radial Forearm Versus the Ulnar Forearm Free Flap
Official title: Comparison of Functional Outcomes and Morbidity of the Radial Forearm Versus the Ulnar Forearm Free Flap: A Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Free Tissue Flaps
Keywords: Radial Forearm Free Flap
Ulnar Forearm Free Flap
Free Tissue Transfer
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects are assigned to one of two treatment arms
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Average Grip Strength (lbs) in the operative hand and non-operative hand
timeFrame: up to 6 months
measure: Average Key Pinch Strength (lbs) in the operative hand and non-operative hand
timeFrame: up to 6 months
measure: Average Physician and Patient Rating of Scar Appearance
timeFrame: up to 6 months
measure: Aggregated Brief Michigan Hand Questionnaire results (composite score)
timeFrame: up to 6 months
measure: Average Static Two Point Discrimination (mm)
timeFrame: up to 6 months
Secondary outcomes:
measure: Number of patients with complete flap loss
timeFrame: up to 6 months
measure: Number of patients with partial flap loss
timeFrame: up to 6 months
measure: Number of patients reporting cold intolerance
timeFrame: up to 6 months
measure: Number of patients reporting neuropathy
timeFrame: up to 6 months
measure: Number of patients with postoperative hematoma at donor site
timeFrame: up to 6 months
measure: Number of patients with postoperative cellulitis at donor site
timeFrame: up to 6 months
measure: Number of patients with postoperative hematoma at recipient site
timeFrame: up to 6 months
measure: Number of patient with postoperative infection at recipient site
timeFrame: up to 6 months
measure: Number of patients experiencing mortality
timeFrame: up to 6 months
measure: Number of patients with donor site dehiscence
timeFrame: up to 6 months
measure: Number of patients with partial skin graft non-take
timeFrame: up to 6 months
measure: Number of patients with complete skin graft non-take
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Eskenazi Hospital
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Joshua Adkinson, M.D.
role: PRINCIPAL_INVESTIGATOR
References: