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

Study Overview
=================
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.

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

Conditions
-----------------
Parotid Tumor

Intervention / Treatment
-----------------
* Procedure: ADM


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADM group<br>29 patients (ADM group) had a total parotidectomy with a simultaneous ADM implantation | Procedure: ADM<br>* 29 patients (ADM group) had a total parotidectomy with a simultaneous ADM implantation<br>* Other names: Acellular dermal matrix;|
| No Intervention: control group<br>41 patients (control group) had a total parotidectomy alone | |

What is the study measuring?
-----------------
Primary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
human acellular dermal matrix, parotid tumor, total parotidectomy