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

Phase 3

Completed

• Conditions: Parotid Tumor
• Interventions: Procedure: ADM

• Registration Number: NCT01414790
• Lead Sponsor: West China Hospital

Brief 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.

Study Timeline

• Study Start: 2004-01
• Status Verified: 2011-01
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Study First Submitted: 2011-08-10
• Study First Submitted QC: 2011-08-10
• Last Update Submitted: 2011-08-10
• Study First Posted: 2011-08-11
• Last Update Posted: 2011-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• (1) a clinical and imaging diagnosis of either a malignant parotid tumor or deep parotid tumor
• (2) no previous surgical treatment

Exclusion Criteria

• recurrent parotid tumors or patients who had previously undergone unsuccessful surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADM group	ADM	29 patients (ADM group) had a total parotidectomy with a simultaneous ADM implantation

Primary Outcome Measures

Name	Time	Method
infraauricular depressed deformities and the presence of gustatory flushing or sweating	from 6 months to 7 years after surgery	to explore whether human acellular dermal matrix (ADM) implantation could prevent infraauricular depressed deformities and Frey's syndrome following total parotidectomy

Trial Locations

Locations (1)

West China Hospital of Stomatology; 🇨🇳 Chengdu, Sichuan, China