NCT07558096

Brief Summary

Radial forearm free flap (RFFF) reconstruction is commonly used for head and neck defects but is associated with donor-site morbidity, including neuropathic pain and sensory disturbance. This randomized controlled pilot study evaluates whether placement of a soft tissue matrix over the superficial radial nerve at the donor site reduces neuropathic pain and improves sensory outcomes compared to standard closure alone.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
42mo left

Started Jul 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 30, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

3.4 years

First QC Date

April 23, 2026

Last Update Submit

April 23, 2026

Conditions

Head and Neck Cancer (H&N)

Keywords

Head and Neck CancerRadial forearm free flapNeuropathic painSuperficial radial nerveDonor site morbiditySoft tissue matrix

Outcome Measures

Primary Outcomes (2)

  • Clinically Significant Neuropathic Pain at 6 Months - DN4 score

    A DN4 questionnaire score of 4 or higher out of 10 indicates a high probability of neuropathic pain. This validated tool, which can be viewed in this DN4 Questionnaire consists of seven patient-interview questions and three clinician-examination items, with a total score distinguishing neuropathic from non-neuropathic pain. A score greater than or equal to 4 is considered positive for neuropathic pain

    6 months

  • Clinically Significant Neuropathic Pain at 6 Months - Numeric Rating Scale

    Numeric Rating Scale (NRS) is used to measure pain, where 0 is "no pain" and 10 is "worst pain imaginable"

    6 months

Secondary Outcomes (7)

  • Average Pain Severity

    1, 3, 6, and 12 months

  • Average Sensory Function with Semmes-Weinstein monofilament testing

    1, 3, 6, and 12 months

  • Average Sensory Function with Static 2-point discrimination

    1, 3, 6, and 12 months

  • Percentage of Skin Graft Loss

    up to 3 months

  • Number of Participants that develop Infection

    Up to 3 months

  • +2 more secondary outcomes

Study Arms (2)

Standard Closure (Control)

ACTIVE COMPARATOR

* Standard RFFF harvest * Split-thickness skin graft (STSG) donor-site closure

Procedure: Standard Closure (Control)

Avive+ Intervention

EXPERIMENTAL

* Standard RFFF harvest * Placement of Avive+ Soft Tissue Matrix over the superficial radial nerve * STSG donor-site closure

Procedure: Avive+ Intervention

Interventions

Standard Closure (Control)PROCEDURE

* Standard RFFF harvest * Split-thickness skin graft (STSG) donor-site closure

Standard Closure (Control)
Avive+ InterventionPROCEDURE

* Standard RFFF harvest * Placement of Avive+ Soft Tissue Matrix over the superficial radial nerve * STSG donor-site closure

Avive+ Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Undergoing RFFF for head and neck reconstruction
  • Treated at University of Alabama at Birmingham
  • Able to provide informed consent
  • Willing to comply with follow-up

You may not qualify if:

  • Reconstruction using a non-RFFF free flap
  • Pre-existing ipsilateral radial nerve neuropathy
  • Prior ipsilateral forearm surgery affecting nerve anatomy
  • Active donor-site infection
  • Severe peripheral vascular disease
  • Inability to complete follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsNeuralgia

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • John M Le, MD, DDS

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John M Le, MD, DDS

CONTACT

205-975-6356jle@uabmc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 23, 2026

First Posted

April 30, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)