Porcine Extracellular Matrix Nerve Wrap in Neck Dissection for Head and Neck Cancer

Henry Ford Health

Status: Suspended

Conditions: Postoperative Complications; Neck Dissection; Head and Neck Cancer

Treatments: Device: Porcine Extracellular Matrix Nerve Wrap (AxoGuard Nerve Protector™)

Study type: Interventional

Funder types: Other

Identifiers

NCT07268092

HFHS-1901

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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74 participants in 2 patient groups

Treatment Arm - Neck dissection with AxoGuard Nerve Protector™

Experimental group

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.

Treatment:

Device: Porcine Extracellular Matrix Nerve Wrap (AxoGuard Nerve Protector™)

Control Arm - Neck dissection without AxoGuard Nerve Protector™.

No Intervention group

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.