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

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.

Study Overview

• Status: Suspended
• Conditions: Postoperative Complications; Head and Neck Cancer; Neck Dissection
• Intervention / Treatment: Device: Porcine Extracellular Matrix Nerve Wrap (AxoGuard Nerve Protector™)

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.

• Study Type: Interventional
• Enrollment (Estimated): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm - Neck dissection with AxoGuard Nerve Protector™; 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.	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.
No Intervention: Control Arm - Neck dissection without AxoGuard Nerve Protector™.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in shoulder flexion active range of motion (degrees)	Shoulder flexion active range of motion will be measured using goniometry. A clinically significant decline is defined as a ≥12° decrease compared to preoperative baseline. Unit of Measure: Degrees	From preoperative baseline assessment up to 12 months post-surgery
Change from baseline in Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) score	Subjective upper extremity function will be assessed using the QuickDASH questionnaire (0-100 scale, higher scores indicate worse disability). Unit of Measure: Score	From preoperative baseline assessment up to 12 months post-surgery
Change from baseline in Neck Dissection Impairment Index (NDII) score	Subjective shoulder-related quality of life will be assessed using the NDII questionnaire (0-50 scale, higher scores indicate greater impairment). Unit of Measure: Score	From preoperative baseline assessment up to 12 months post-surgery
Change from baseline in shoulder abduction active range of motion (degrees	Shoulder abduction active range of motion will be measured using goniometry. A clinically significant decline is defined as a ≥23° decrease compared to preoperative baseline. Unit of Measure: Degrees	From preoperative baseline assessment up to 12 months post-surgery

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Samantha Tam, MD, Henry Ford Health System

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2021
• Primary Completion (Estimated): August 12, 2026
• Study Completion (Estimated): August 12, 2026

Study Registration Dates

• First Submitted: July 9, 2025
• First Submitted That Met QC Criteria: December 3, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): December 5, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Postoperative Complications; Shoulder Dysfunction; Spinal Accessory Nerve Injury; Nerve Compression Syndromes
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Pathologic Processes; Neoplasms by Site; Neoplasms; Neuromuscular Diseases; Peripheral Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Cranial Nerve Diseases; Cranial Nerve Injuries; Pathological Conditions, Signs and Symptoms; Accessory Nerve Diseases; Head and Neck Neoplasms; Nerve Compression Syndromes; Postoperative Complications; Accessory Nerve Injuries
• Other Study ID Numbers: HFHS-1901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes