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Radial Forearm Versus the Ulnar Forearm Free Flap

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ClinicalTrials.gov Identifier: NCT03579277
Recruitment Status : Enrolling by invitation
First Posted : July 6, 2018
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Joshua Adkinson, Indiana University

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.

Condition or disease Intervention/treatment Phase
Free Tissue Flaps Procedure: Radial Forearm Free Flap Procedure: Ulnar Forearm Free Flap Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects are assigned to one of two treatment arms
Masking: Single (Investigator)
Masking Description: To the extend possible based on the nature of the study, subjects and researchers will be masked from the treatment arms.
Primary Purpose: Treatment
Official Title: Comparison of Functional Outcomes and Morbidity of the Radial Forearm Versus the Ulnar Forearm Free Flap: A Prospective, Randomized Trial
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : January 15, 2021

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.




Primary Outcome Measures :
  1. Average Grip Strength (lbs) in the operative hand and non-operative hand [ Time Frame: up to 6 months ]
    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.

  2. Average Key Pinch Strength (lbs) in the operative hand and non-operative hand [ Time Frame: up to 6 months ]
    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.

  3. Average Physician and Patient Rating of Scar Appearance [ Time Frame: up to 6 months ]
    Subject's and physician's reported assessment of scar appearance on a Likert scale up to 10.

  4. Aggregated Brief Michigan Hand Questionnaire results (composite score) [ Time Frame: up to 6 months ]
    Subjects' reported outcomes of hand function, as measured by the brief Michigan Hand Questionnaire survey results, on a scale up to 100.

  5. Average Static Two Point Discrimination (mm) [ Time Frame: up to 6 months ]
    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.


Secondary Outcome Measures :
  1. Number of patients with complete flap loss [ Time Frame: up to 6 months ]
    Number of patients with complete flap loss as assessed by chart review.

  2. Number of patients with partial flap loss [ Time Frame: up to 6 months ]
    Number of patients with partial flap loss as assessed by chart review.

  3. Number of patients reporting cold intolerance [ Time Frame: up to 6 months ]
    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.

  4. Number of patients reporting neuropathy [ Time Frame: up to 6 months ]
    Number of patients reporting cold intolerance as assessed by patient's response to questioning them about feeling neuropathy

  5. Number of patients with postoperative hematoma at donor site [ Time Frame: up to 6 months ]
    Number of patients with postoperative hematoma at donor site, as assessed by chart review.

  6. Number of patients with postoperative cellulitis at donor site [ Time Frame: up to 6 months ]
    Number of patients with postoperative cellulitis at donor site as assessed by chart review.

  7. Number of patients with postoperative hematoma at recipient site [ Time Frame: up to 6 months ]
    Number of patient with postoperative hematoma at recipient site, as assessed by chart review

  8. Number of patient with postoperative infection at recipient site [ Time Frame: up to 6 months ]
    Number of patient with postoperative infection at recipient site, as assessed by chart review.

  9. Number of patients experiencing mortality [ Time Frame: up to 6 months ]
    Number of patients experiencing mortality, as assessed by chart review.

  10. Number of patients with donor site dehiscence [ Time Frame: up to 6 months ]
    Number of patients with donor site dehiscence, as assessed by chart review

  11. Number of patients with partial skin graft non-take [ Time Frame: up to 6 months ]
    Number of patients with partial skin graft non-take, as assessed by chart review

  12. Number of patients with complete skin graft non-take [ Time Frame: up to 6 months ]
    Number of patients with complete skin graft non-take, as assessed by chart review



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03579277


Locations
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United States, Indiana
Eskenazi Hospital
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University
Investigators
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Principal Investigator: Joshua Adkinson, M.D. Indiana University School of Medicine

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Responsible Party: Joshua Adkinson, Chief of Hand Surgery, Indiana University
ClinicalTrials.gov Identifier: NCT03579277     History of Changes
Other Study ID Numbers: 1712593520
First Posted: July 6, 2018    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joshua Adkinson, Indiana University:
Radial Forearm Free Flap
Ulnar Forearm Free Flap
Free Tissue Transfer