NCT01414790

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 10 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Parotid Tumor

Interventions

Type	Name	Description
PROCEDURE	ADM	29 patients (ADM group) had a total parotidectomy with a simultaneous ADM implantation

Timeline

• Start date: 2004-01-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2011-08-11
• Last updated: 2011-08-11

Locations

1 site across 1 country: China