Evaluating Avive+ Soft Tissue Matrix for Prevention of Superficial Radial Nerve Morbidity Following Radial Forearm Free Flap Harvest
7. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Antatt)
80
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: John M Le, MD, DDS
- Telefonnummer: 205-975-6356
- E-post: jle@uabmc.edu
Studiesteder
-
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Alabama
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Birmingham, Alabama, Forente stater, 35294
- University of Alabama at Birmingham
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Ta kontakt med:
- John M Le, MD, DDS
- Telefonnummer: 205-975-6356
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Standard Closure (Control)
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Eksperimentell: Avive+ Intervention
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Clinically Significant Neuropathic Pain at 6 Months - DN4 score
Tidsramme: 6 months
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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
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Numeric Rating Scale (NRS) is used to measure pain, where 0 is "no pain" and 10 is "worst pain imaginable"
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6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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"
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1, 3, 6, and 12 months
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Average Sensory Function with Semmes-Weinstein monofilament testing
Tidsramme: 1, 3, 6, and 12 months
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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
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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
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Percentage of Skin Graft Loss
Tidsramme: up to 3 months
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Measured by percentage of 0-100% total graft loss.
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up to 3 months
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Number of Participants that develop Infection
Tidsramme: Up to 3 months
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Measured by presence of cellulitis/purulence requiring antibiotics and/or surgical debridement with antibiotics.
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Up to 3 months
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Number of participants with Tendon Exposure
Tidsramme: up to 3 months
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Measured by number of participants with visual appearance of tendon exposure.
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up to 3 months
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Change in QuickDASH score
Tidsramme: 3, 6, and 12 months
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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
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: John M Le, MD, DDS, University of Alabama at Birmingham
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. august 2026
Primær fullføring (Antatt)
1. desember 2029
Studiet fullført (Antatt)
1. desember 2029
Datoer for studieregistrering
Først innsendt
23. april 2026
Først innsendt som oppfylte QC-kriteriene
23. april 2026
Først lagt ut (Faktiske)
30. april 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB-300016607
- UAB (Annen identifikator: UAB)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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