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Radial Forearm Versus the Ulnar Forearm Free Flap

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Indiana University

Status

Terminated

Conditions

Free Tissue Flaps

Treatments

Procedure: Radial Forearm Free Flap
Procedure: Ulnar Forearm Free Flap

Study type

Interventional

Funder types

Other

Identifiers

NCT03579277
1712593520

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

24 participants in 2 patient groups

Radial forearm free flap
Active Comparator group
Description:
Subjects in this arm will receive a radial forearm free flap.
Treatment:
Procedure: Radial Forearm Free Flap
Ulnar forearm free flap
Active Comparator group
Description:
Subjects in this arm will receive an ulnar forearm free flap.
Treatment:
Procedure: Ulnar Forearm Free Flap

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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