The Use of Human Acellular Dermal Matrix to Improve Infraauricular Depressed Deformities and Frey's Syndrome

Parotid Tumor Clinical Trial

Official title: The Use of Human Acellular Dermal Matrix in the Prevention of Infraauricular Depressed Deformities and Frey's Syndrome Following Total Parotidectomy

Status Completed

Clinical Trial Summary

The aim of the study was to explore whether human acellular dermal matrix (ADM) implantation could prevent infraauricular depressed deformities and Frey's syndrome following total parotidectomy.

Clinical Trial Description

Seventy patients who underwent total parotidectomy were selected for inclusion in the study. We analyzed 41 cases of total parotidectomy (control group) and 29 cases of simultaneous ADM implantation following total parotidectomy (ADM group) for infraauricular depressed deformities and the presence of gustatory flushing or sweating. The follow-up periods ranged from 6 months to 7 years.

The Results showed facial contours and bilateral symmetry improved after surgery in the ADM group. In the control group, an infraauricular depressed deformity was evident in all 41 cases. Frey's syndrome was recorded in one patient (3.4%) from the ADM group and 14 patients (34.1%) from the control group. No cases of immune rejection, infection, hematoma, or salivary fistula were observed in either group. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Parotid Neoplasms
• Parotid Tumor

• NCT number: NCT01414790
• Study type: Interventional
• Source: West China Hospital
• Status: Completed
• Phase: Phase 3
• Start date: January 2004
• Completion date: January 2011