An interventional study of Standard Closure (Control) and Avive+ Intervention in Head and Neck Cancer (H&N), sponsored by University of Alabama at Birmingham. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention
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.
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.
2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.
This study's planned enrollment of 80 is above the median of 46 across 2,032 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* Standard RFFF harvest * Split-thickness skin graft (STSG) donor-site closure
Procedure: Standard Closure (Control)
* Standard RFFF harvest * Placement of Avive+ Soft Tissue Matrix over the superficial radial nerve * STSG donor-site closure
Procedure: Avive+ Intervention
* Standard RFFF harvest * Split-thickness skin graft (STSG) donor-site closure
* Standard RFFF harvest * Placement of Avive+ Soft Tissue Matrix over the superficial radial nerve * STSG donor-site closure
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
Time frame: 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"
Time frame: 6 months
Average Pain Severity
Numeric Rating Scale (NRS): Commonly used in healthcare to measure pain, where 0 is "no pain" and 10 is "worst pain imaginable"
Time frame: 1, 3, 6, and 12 months
Average Sensory Function with Semmes-Weinstein monofilament testing
The Semmes-Weinstein monofilament test is a quick, non-invasive, and objective clinical exam used to evaluate nerve function by measuring skin sensitivity to light touch and pressure.
Time frame: 1, 3, 6, and 12 months
Average Sensory Function with Static 2-point discrimination
Static 2-point discrimination (2PD) is a clinical test measuring the minimum distance at which a patient can perceive two simultaneous touch stimuli as distinct, rather than one, using a device like an aesthesiometer or disk-criminator.
Time frame: 1, 3, 6, and 12 months
Percentage of Skin Graft Loss
Measured by percentage of 0-100% total graft loss.
Time frame: up to 3 months
Number of Participants that develop Infection
Measured by presence of cellulitis/purulence requiring antibiotics and/or surgical debridement with antibiotics.
Time frame: Up to 3 months
Number of participants with Tendon Exposure
Measured by number of participants with visual appearance of tendon exposure.
Time frame: up to 3 months
Change in QuickDASH score
The QuickDASH is an 11-item questionnaire assessing upper limb musculoskeletal disability, scoring from 0 (no disability) to 100 (most severe).
Time frame: 3, 6, and 12 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Dec 2029, 37 months later.
Of 437 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's planned 37 months is above that.
Counting every sponsor, half of 455 studies reached it within 32 months; a quarter within 18 and three quarters within 70.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Nov 2026, on Sep 25, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham →