Head and Neck Cancer (H&N)NCT07558096
Evaluating Avive+ Soft Tissue Matrix for Prevention of Superficial Radial Nerve Morbidity Following Radial Forearm Free Flap Harvest
A study testing Avive+ Intervention in people with Head and Neck Cancer (H&N), run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer (H&N)
- What is being tested?
- Avive+ Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
John M Le, MD, DDS, 205-975-6356
About this study
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
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.
Read the 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.
- Conditions
- Head and Neck Cancer (H&N)
- Being tested
- Standard Closure (Control), Avive+ Intervention
- Keywords
- Head and Neck Cancer, Radial forearm free flap, Neuropathic pain, Superficial radial nerve, Donor site morbidity, Soft tissue matrix
- Medical subject headings
- Head and Neck Neoplasms, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Closure (Control)Procedure or surgery
- Standard RFFF harvest
- Split-thickness skin graft (STSG) donor-site closure
Avive+ InterventionProcedure or surgery
- Standard RFFF harvest
- Placement of Avive+ Soft Tissue Matrix over the superficial radial nerve
- STSG donor-site closure
| Study group | Role | What they receive |
|---|---|---|
| Standard Closure (Control) | Active comparator | * Standard RFFF harvest
* Split-thickness skin graft (STSG) donor-site closure Receives: 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 Receives: Procedure: Avive+ Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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"
Measured: 6 months
Secondary outcomes (7)
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"
Measured: 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.
Measured: 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.
Measured: 1, 3, 6, and 12 months
Percentage of Skin Graft Loss
Measured by percentage of 0-100% total graft loss.
Measured: up to 3 months
Number of Participants that develop Infection
Measured by presence of cellulitis/purulence requiring antibiotics and/or surgical debridement with antibiotics.
Measured: Up to 3 months
Number of participants with Tendon Exposure
Measured by number of participants with visual appearance of tendon exposure.
Measured: 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).
Measured: 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Cancer (H&N)Studies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John M Le, University of Alabama at Birmingham
- Investigators
- John M Le, MD, DDS, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558096
- Sponsor's protocol ID
- IRB-300016607
- Other IDs
- UAB
- Status last verified
- Aug 2026
- First submitted
- 23 Apr 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07558096
- Acronym / sponsor ID
- IRB-300016607
- Conditions
- Head and Neck Cancer (H&N)
- Keywords
- Head and Neck Cancer, Radial forearm free flap, Neuropathic pain, Superficial radial nerve, Donor site morbidity, Soft tissue matrix
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Closure (Control) | Active comparator | Procedure: Standard Closure (Control)* Standard RFFF harvest * Split-thickness skin graft (STSG) donor-site closure |
| Avive+ Intervention | Experimental | Procedure: Avive+ Intervention* Standard RFFF harvest * Placement of Avive+ Soft Tissue Matrix over the superficial radial nerve * STSG donor-site closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Closure (Control)* Standard RFFF harvest * Split-thickness skin graft (STSG) donor-site closure | Procedure or surgery | Standard Closure (Control) |
| Avive+ Intervention* Standard RFFF harvest * Placement of Avive+ Soft Tissue Matrix over the superficial radial nerve * STSG donor-site closure | Procedure or surgery | Avive+ Intervention |
Primary outcome
Clinically Significant Neuropathic Pain at 6 Months - DN4 score
Time frame: 6 months
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
Clinically Significant Neuropathic Pain at 6 Months - Numeric Rating Scale
Time frame: 6 months
Numeric Rating Scale (NRS) is used to measure pain, where 0 is "no pain" and 10 is "worst pain imaginable"
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John M Le, MD, DDS principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Avive+ Intervention in people with Head and Neck Cancer (H&N), run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John M Le, MD, DDS (205-975-6356, jle@uabmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically Significant Neuropathic Pain at 6 Months - DN4 score (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.