Head and Neck Cancer, Neck Dissection, Postoperative Complications
Conditions
Keywords
Spinal Accessory Nerve Injury, Shoulder Dysfunction, Head and Neck Cancer, Nerve Compression Syndromes, Postoperative Complications
Brief 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.
Interventions
DEVICEPorcine 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.
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in shoulder flexion active range of motion (degrees) | From preoperative baseline assessment up to 12 months post-surgery | 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 |
| Change from baseline in Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) score | From preoperative baseline assessment up to 12 months post-surgery | Subjective upper extremity function will be assessed using the QuickDASH questionnaire (0-100 scale, higher scores indicate worse disability). Unit of Measure: Score |
| Change from baseline in Neck Dissection Impairment Index (NDII) score | From preoperative baseline assessment up to 12 months post-surgery | 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 |
| Change from baseline in shoulder abduction active range of motion (degrees | From preoperative baseline assessment up to 12 months post-surgery | 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 |
Countries
United States
Outcome results
None listed