Evaluating Avive+ Soft Tissue Matrix for Prevention of Superficial Radial Nerve Morbidity Following Radial Forearm Free Flap Harvest
7. juli 2026 opdateret af: John M Le, University of Alabama at Birmingham
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
80
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: John M Le, MD, DDS
- Telefonnummer: 205-975-6356
- E-mail: jle@uabmc.edu
Studiesteder
-
-
Alabama
-
Birmingham, Alabama, Forenede Stater, 35294
- University of Alabama at Birmingham
-
Kontakt:
- John M Le, MD, DDS
- Telefonnummer: 205-975-6356
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Standard Closure (Control)
|
|
|
Eksperimentel: Avive+ Intervention
|
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinically Significant Neuropathic Pain at 6 Months - DN4 score
Tidsramme: 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
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6 months
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Clinically Significant Neuropathic Pain at 6 Months - Numeric Rating Scale
Tidsramme: 6 months
|
Numeric Rating Scale (NRS) is used to measure pain, where 0 is "no pain" and 10 is "worst pain imaginable"
|
6 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Average Pain Severity
Tidsramme: 1, 3, 6, and 12 months
|
Numeric Rating Scale (NRS): Commonly used in healthcare to measure pain, where 0 is "no pain" and 10 is "worst pain imaginable"
|
1, 3, 6, and 12 months
|
|
Average Sensory Function with Semmes-Weinstein monofilament testing
Tidsramme: 1, 3, 6, and 12 months
|
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.
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1, 3, 6, and 12 months
|
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Average Sensory Function with Static 2-point discrimination
Tidsramme: 1, 3, 6, and 12 months
|
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.
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1, 3, 6, and 12 months
|
|
Percentage of Skin Graft Loss
Tidsramme: up to 3 months
|
Measured by percentage of 0-100% total graft loss.
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up to 3 months
|
|
Number of Participants that develop Infection
Tidsramme: Up to 3 months
|
Measured by presence of cellulitis/purulence requiring antibiotics and/or surgical debridement with antibiotics.
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Up to 3 months
|
|
Number of participants with Tendon Exposure
Tidsramme: up to 3 months
|
Measured by number of participants with visual appearance of tendon exposure.
|
up to 3 months
|
|
Change in QuickDASH score
Tidsramme: 3, 6, and 12 months
|
The QuickDASH is an 11-item questionnaire assessing upper limb musculoskeletal disability, scoring from 0 (no disability) to 100 (most severe).
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3, 6, and 12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: John M Le, MD, DDS, University of Alabama at Birmingham
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. august 2026
Primær færdiggørelse (Anslået)
1. december 2029
Studieafslutning (Anslået)
1. december 2029
Datoer for studieregistrering
Først indsendt
23. april 2026
Først indsendt, der opfyldte QC-kriterier
23. april 2026
Først opslået (Faktiske)
30. april 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB-300016607
- UAB (Anden identifikator: UAB)
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