Complications associated with Dermabond® during head and neck surgery: MAUDE and literature review.
American journal of otolaryngology
Adverse events; Dermabond; Head and neck; Literature review; MAUDE.
INTRODUCTION: Dermabond® is a liquid surgical sealant containing 2-octyl-cyanoacrylate that has been widely used during head and neck surgeries. This study aims to provide a summary of adverse events related to Dermabond® in head and neck procedures as reported in the MAUDE database, and to report a complete overview of all documented adverse events related to Dermabond® use in current literature.
METHODS: The US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database was queried for reports of adverse events related to Dermabond® use from January 1, 2010, to February 1, 2020. Data were extracted from reports pertaining to head and neck procedures. In addition, literature review was performed from January 1970 to January 2021. Various adverse events related to Dermabond® were included in the study.
RESULTS: We identified 32 adverse events, from which 29 (90.6%) were patient-related events and 3 (9.4%) were operator-related events. Of the patient-related events, contact dermatitis (CD) (20 [69.0%]) was the most common, followed by wound dehiscence (4 [13.8%]). All of the operator-related events were from inadvertent cut injury (3 [100%]). Following the literature review, adverse events of Dermabond® were categorized into CD, wound dehiscence, infection, and cut injury.
CONCLUSION: Dermabond® demonstrated utility in various surgical procedures including head and neck surgeries but are associated with risks. This study identified adverse events associated with Dermabond®. Further studies are needed to establish the causation of contact dermatitis in certain populations.
Lee, E., Elzomor, A., Zwemer, C., Chen, A., & Thakkar, P. G. (2021). Complications associated with Dermabond® during head and neck surgery: MAUDE and literature review.. American journal of otolaryngology, 43 (2). http://dx.doi.org/10.1016/j.amjoto.2021.103330