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NCT07558096 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by University of Alabama at Birmingham.

Not yet
Registry status
NA
Development phase
80
Enrollment target

NCT07558096: Clinical Trial NA study, sponsored by University of Alabama at Birmingham.

NCT07558096 is a NA study that has not yet begun recruiting, run by University of Alabama at Birmingham. The registered enrollment target is 80 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07558096, a NA study, has not yet begun recruiting, sponsored by University of Alabama at Birmingham.

NOT YET RECRUITING
Registry status
NA
Development phase
80 participants
Enrollment target

Study 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.

Primary Outcome

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

Interventions

  • PROCEDURE Standard Closure (Control)
  • PROCEDURE Avive+ Intervention

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2026-08
Est. Completion 2029-12
Phase NA
University of Alabama at Birmingham

1,160 total trials

What is known before NCT07558096 opens enrollment

NCT07558096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 2 interventions - of which Standard Closure (Control) is the first listed.

NCT07558096 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07558096 about?

NCT07558096 is a clinical study titled "Evaluating Avive+ Soft Tissue Matrix for Prevention of Superficial Radial Nerve Morbidity Following Radial Forearm Free Flap Harvest". 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 r...

What is the current status of trial NCT07558096?

This trial is currently not yet recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2026-08. Estimated completion is 2029-12.

What interventions are being tested in trial NCT07558096?

The interventions under investigation include: Standard Closure (Control) (PROCEDURE), Avive+ Intervention (PROCEDURE).

Who is sponsoring clinical trial NCT07558096?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07558096's enrollment target sits among peer trials

80 994th of 2000 higher than 941 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07558096, the US trial registry maintained by the National Library of Medicine. NCT07558096 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.