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

Sichuan University

Status and phase: Completed; Phase 3

Conditions: Parotid Tumor

Treatments: Procedure: ADM

Study type: Interventional

Funder types: Other

Identifiers

NCT01414790

luowen228

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 10 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

ADM group

Experimental group

Description:

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

Treatment:

Procedure: ADM

control group

No Intervention group

Description:

41 patients (control group) had a total parotidectomy alone