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

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.

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Key information

Conditions

Parotid Tumor Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Parotid Diseases Parotid Neoplasms Salivary Gland Diseases Salivary Gland Neoplasms Stomatognathic Diseases

Age range

10 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

West China Hospital of Stomatology

Chengdu, Sichuan, 610041, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADM

Procedure

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

Other names: Acellular dermal matrix

Primary outcomes

infraauricular depressed deformities and the presence of gustatory flushing or sweating

Time frame: 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

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2004
Primary completion: 2011
Study completion: 2011
First posted: Aug 11, 2011
Registry last updated: Aug 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed