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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01414790

Enrollment

Registered

2011-08-11

Start date

2004-01-31

Completion date

2011-01-31

Last updated

2011-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parotid Tumor

Keywords

human acellular dermal matrix, parotid tumor, total parotidectomy

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.

Interventions

PROCEDUREADM

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

10 Years to 79 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026