Clinical trial · Interventional
Porcine Extracellular Matrix Nerve Wrap in Neck Dissection for Head and Neck Cancer
Impact of Porcine Extracellular Matrix Nerve Wrap on Spinal Accessory Nerve in Patients Undergoing Neck Dissection for Head and Neck Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Dr Tam have collected the first 20 patients for interim analysis per the protocol, and are trying to get these data to perform interim analyses on these data to best understand how to move forwards.
Summary
Brief summary (as posted)
Perform a preliminary efficacy study using the porcine extracellular matrix nerve wrap (AxoGuard Nerve Protector™, AxoGen Inc., Alachua, FL) to wrap the spinal accessory nerve (SAN) during neck dissections for head and neck cancer as it relates to postoperative shoulder function, both subjectively and objectively.
Conditions
Conditions (3)
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 | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Neck Dissection | — | UNRESOLVED | — |
| Postoperative Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Porcine Extracellular Matrix Nerve Wrap (AxoGuard Nerve Protector™) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatment Arm - Neck dissection with AxoGuard Nerve Protector™
- description
- Participants undergo neck dissection surgery for head and neck cancer, during which the spinal accessory nerve (SAN) is wrapped with the AxoGuard Nerve Protector™ (porcine extracellular matrix nerve wrap). This intervention aims to improve postoperative shoulder function by protecting and supporting the nerve during healing. Postoperative physical therapy evaluations will be conducted at baseline, immediate post-op, 1, 6, and 12 months.
- interventionNames
- Device: Porcine Extracellular Matrix Nerve Wrap (AxoGuard Nerve Protector™)
- type
- NO_INTERVENTION
- label
- Control Arm - Neck dissection without AxoGuard Nerve Protector™.
- description
- Participants undergo standard neck dissection surgery for head and neck cancer without the application of the AxoGuard Nerve Protector™. Postoperative physical therapy evaluations will be conducted at baseline, immediate post-op, 1, 6, and 12 months to assess shoulder function.
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients at least 18 years old * Patients with no previous treatment of head and neck cancer * Patients with no prior neck surgeries * Patients undergoing level IIA and IIB neck diss Exclusion Criteria: * Patients with previously treated head and neck cancers * Patients undergoing level V neck dissection * Patients undergoing bilateral neck dissection * Patients with previous neck surgery unrelated to head and neck cancer * Patients allergic to porcine products or with religious/cultural restrictions on porcine products * Patients unable to consent * Individuals who are not adults (infants, children, teenagers) * Pregnant women * Prisoners
References
Publications (0)
Data not yet available