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Not yet recruiting NCT07558096

Evaluating Avive+ Soft Tissue Matrix for Prevention of Superficial Radial Nerve Morbidity Following Radial Forearm Free Flap Harvest

No phase Interventional Head and Neck Cancer (H&N)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard Closure (Control), Avive+ Intervention.
Who it may be relevant to
Registry conditions: Head and Neck Cancer (H&N). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Randomized Controlled Pilot Study Evaluating Avive+ Soft Tissue Matrix for Prevention of Superficial Radial Nerve Morbidity Following Radial Forearm Free Flap Harvest

Overview

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.

Detailed description

Radial forearm free flap (RFFF) harvest is associated with significant donor-site morbidity, including neuropathic pain, hypoesthesia, and functional impairment related to superficial radial nerve irritation and postoperative scar formation. Current donor-site management focuses on wound closure and healing but does not directly address nerve protection.

Avive+ Soft Tissue Matrix is a human-derived biologic material designed for soft tissue reinforcement and protection. Its use as a barrier over surgically manipulated nerves is biologically plausible but has not been studied in this clinical context.

This study is a prospective, randomized controlled pilot trial designed to evaluate the feasibility, safety, and preliminary efficacy of Avive+ placement over the superficial radial nerve during RFFF harvest. Subjects will be randomized to standard closure versus Avive+ placement plus standard closure. Outcomes will focus on neuropathic pain, sensory function, and wound complications.

Interventions

  • Procedure Standard Closure (Control)
    * Standard RFFF harvest * Split-thickness skin graft (STSG) donor-site closure
  • Procedure Avive+ Intervention
    * Standard RFFF harvest * Placement of Avive+ Soft Tissue Matrix over the superficial radial nerve * STSG donor-site closure

Primary outcome measures

  • Clinically Significant Neuropathic Pain at 6 Months - DN4 score [Time frame: 6 months]
  • Clinically Significant Neuropathic Pain at 6 Months - Numeric Rating Scale [Time frame: 6 months]
Secondary outcome measures (7)
  • Average Pain Severity [Time frame: 1, 3, 6, and 12 months]
  • Average Sensory Function with Semmes-Weinstein monofilament testing [Time frame: 1, 3, 6, and 12 months]
  • Average Sensory Function with Static 2-point discrimination [Time frame: 1, 3, 6, and 12 months]
  • Percentage of Skin Graft Loss [Time frame: up to 3 months]
  • Number of Participants that develop Infection [Time frame: Up to 3 months]
  • Number of participants with Tendon Exposure [Time frame: up to 3 months]
  • Change in QuickDASH score [Time frame: 3, 6, and 12 months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Alabama at Birmingham — Birmingham

Identifiers

NCT: NCT07558096 · IRB-300016607 · UAB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗