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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03579277
Other study ID # 1712593520
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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