The preventive effect of decellularized pericardial patch against Frey's syndrome following the superficial...

This study aimed to investigate the feasibility of adopting the ThormalGEN surgical patch (a porcine decellularized pericardial patch) in the superficial parotidectomy to prevent postoperative Frey's syndrome in patients with benign parotid tumor.

A total of 59 patients with benign parotid tumor undergoing superficial parotidectomy between April 2016 and January 2017 were enrolled, and divided into the ThormalGEN group (n = 37) and the control group (n = 22) based on their willingness to have the ThormalGEN surgical patch used in the superficial parotidectomy. At 6 months postoperation, the incidences of postoperative complications and Frey's syndrome were assessed by subjective assessment (patient self-assessment) and objective assessment (starch-iodine test), respectively. The risk factor of Frey's syndrome was analyzed by the multivariate logistic regression model.

The starch-iodine test, for objective assessment, showed that the ThormalGEN group had a significantly lower incidence of Frey's syndrome than the control group (8.11% vs. 40.91%, p = 006). However, in the patient self-assessment, there was no significant difference in the incidence of Frey's syndrome between groups (8.11% [3/37] vs. 13.64% [3/22], p = 0.4968). The incidences of postoperative complications were not significantly different between group (all p > 0.05). Two patients (5.41%) in the ThormalGEN group had salivary fistula. Multivariate logistic regression analysis showed that the ThormalGEN group had a significantly lower risk of Frey's syndrome than the control group (odds ratio = 0.11, 95% confidence interval = 0.02-0.51, p < 0.01).

These results suggest that the ThormalGEN surgical patch can effectively reduce the incidence of Frey's syndrome following superficial parotidectomy in patients with benign parotid tumor, and that this patch has a good safety and biocompatibility profile.