SuspendedNot Applicable

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

Stopped: 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.

United States74 participantsStarted 2021-01-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change from baseline in shoulder flexion active range of motion (degrees)

Timeframe: From preoperative baseline assessment up to 12 months post-surgery

Change from baseline in Quick Disabilities of the Arm, Shoulder, and Hand (QuickDASH) score

Timeframe: From preoperative baseline assessment up to 12 months post-surgery

Change from baseline in Neck Dissection Impairment Index (NDII) score

Timeframe: From preoperative baseline assessment up to 12 months post-surgery

Change from baseline in shoulder abduction active range of motion (degrees

Timeframe: From preoperative baseline assessment up to 12 months post-surgery

Trial details

NCT IDNCT07268092

SponsorHenry Ford Health System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-12

View on ClinicalTrials.gov More Head and Neck Cancer trials