Human Amnion/Chorion Membrane Use During Neck Surgery to Protect the Recurrent Laryngeal Nerve

Abstract

Gary Clayman*, Rashmi Roy and Nathaniel Walsh

Recurrent Laryngeal Nerve (RLN) damage is a significant and prevalent complication of neck surgery of all types. Based on the beneficial role of Human Amnion/Chorion Membrane (HACM) allograft in wound management and nerve regeneration, we investigated whether placement of a commercially available HACM allograft on dissected RLN during thyroidectomy could reduce the occurrence and/or duration of RLN. Preliminary studies in 100 dissected nerves showed benefit in both occurrence and duration, so the study was increased to 1000 consecutive at-risk nerves (dissected exposure of at least 3 cm of RLN) in 670 patients which received HACM directly onto the nerves prior to wound closure. 2000 at-risk nerves without HACM in 1420 matched patients served as controls. All operations were performed by the same surgeons using nerve monitoring endotracheal tubes. Patient-reported vocal analysis, physician-assessed vocal analysis, and laryngoscopic assessment of vocal fold dysfunction were performed before and after surgery. The overall incidence of clinically significant RLN injury at 24 hours after surgery in patients not receiving HACM was 14.4% which decreased to 3.4% in the HACM-treated group (p<0.01). Moreover, the time to resolution of documented RLN decreased from 8.9 weeks to 4.0 weeks (p<0.01). Intraoperative placement of HACM allograft over at-risk RLNs during thyroidectomy appears to decrease both the incidence of and duration of RLN injury, which could address the most significant complication in head and neck surgery.