Clinical trial · Interventional
Evaluating Avive+ Soft Tissue Matrix for Prevention of Superficial Radial Nerve Morbidity Following Radial Forearm Free Flap Harvest
A Randomized Controlled Pilot Study Evaluating Avive+ Soft Tissue Matrix for Prevention of Superficial Radial Nerve Morbidity Following Radial Forearm Free Flap Harvest
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer (H&N) | Malignant Head and Neck Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Avive+ Intervention | Procedure | — | UNRESOLVED |
| Standard Closure (Control) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Closure (Control)
- description
- * Standard RFFF harvest * Split-thickness skin graft (STSG) donor-site closure
- interventionNames
- Procedure: Standard Closure (Control)
- type
- EXPERIMENTAL
- label
- Avive+ Intervention
- description
- * Standard RFFF harvest * Placement of Avive+ Soft Tissue Matrix over the superficial radial nerve * STSG donor-site closure
- interventionNames
- Procedure: Avive+ Intervention
Primary outcomes (2)
- measure
- Clinically Significant Neuropathic Pain at 6 Months - DN4 score
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available