NCT07268092

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Henry Ford Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Many patients who have surgery for head and neck cancer also need a procedure called a neck dissection, where lymph nodes and tissue are removed from the neck. During this surgery, even when a nerve called the spinal accessory nerve (SAN) is carefully preserved, patients often have shoulder problems afterward. These problems can include pain, weakness, and difficulty lifting the arm, which can affect daily activities and quality of life. This study is testing whether using a special nerve wrap made from pig tissue (called AxoGuard® Nerve Protector) can help protect the spinal accessory nerve during surgery and improve shoulder movement and strength after surgery. This nerve wrap is already used in other types of nerve surgeries and may help the nerve heal better by reducing scar tissue and irritation.

Conditions

• Head and Neck Cancer
• Neck Dissection
• Postoperative Complications

Interventions

Type	Name	Description
DEVICE	Porcine Extracellular Matrix Nerve Wrap (AxoGuard Nerve Protector™)	The intervention involves the application of the AxoGuard Nerve Protector™, a nerve wrap derived from porcine extracellular matrix (ECM), to the spinal accessory nerve (SAN) during neck dissection surgery in head and neck cancer patients. The device is designed to protect and support the nerve by preserving the extracellular matrix and creating a favorable environment for nerve healing. This helps prevent inflammation and fibrosis around the nerve, potentially improving postoperative shoulder function. The nerve wrap is applied intraoperatively after dissection but before surgical closure. The study compares this intervention to standard neck dissection without nerve wrapping.

Timeline

• Start date: 2021-01-25
• Primary completion: 2026-08-12
• Completion: 2026-08-12
• First posted: 2025-12-05
• Last updated: 2025-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study