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Clinical Trials/NCT01414790
NCT01414790
Completed
Phase 3

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

West China Hospital1 site in 1 country70 target enrollmentJanuary 2004
ConditionsParotid Tumor

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Parotid Tumor
Sponsor
West China Hospital
Enrollment
70
Locations
1
Primary Endpoint
infraauricular depressed deformities and the presence of gustatory flushing or sweating
Status
Completed
Last Updated
14 years ago

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.

Registry
clinicaltrials.gov
Start Date
January 2004
End Date
January 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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

Outcomes

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

Study Sites (1)

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