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

This study has been completed.
Sponsor:
Information provided by:
West China Hospital
ClinicalTrials.gov Identifier:
NCT01414790
First received: August 10, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Parotid Tumor
Procedure: ADM
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Use of Human Acellular Dermal Matrix in the Prevention of Infraauricular Depressed Deformities and Frey's Syndrome Following Total Parotidectomy

Resource links provided by NLM:


Further study details as provided by West China Hospital:

Primary Outcome Measures:
  • infraauricular depressed deformities and the presence of gustatory flushing or sweating [ Time Frame: from 6 months to 7 years after surgery ] [ Designated as safety issue: Yes ]
    to explore whether human acellular dermal matrix (ADM) implantation could prevent infraauricular depressed deformities and Frey's syndrome following total parotidectomy


Enrollment: 70
Study Start Date: January 2004
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ADM group
29 patients (ADM group) had a total parotidectomy with a simultaneous ADM implantation
Procedure: ADM
29 patients (ADM group) had a total parotidectomy with a simultaneous ADM implantation
Other Name: Acellular dermal matrix
No Intervention: control group
41 patients (control group) had a total parotidectomy alone

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.

  Eligibility

Ages Eligible for Study:   10 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01414790

Locations
China, Sichuan
West China Hospital of Stomatology
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
West China Hospital
Investigators
Study Chair: Wen Luo, DMD West China Hospital of Stomatology
  More Information

Additional Information:
Publications:
Responsible Party: West China Hospital of Stomatology
ClinicalTrials.gov Identifier: NCT01414790     History of Changes
Other Study ID Numbers: luowen228
Study First Received: August 10, 2011
Last Updated: August 10, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by West China Hospital:
human acellular dermal matrix
parotid tumor
total parotidectomy

Additional relevant MeSH terms:
Parotid Neoplasms
Sweating, Gustatory
Salivary Gland Neoplasms
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Parotid Diseases
Salivary Gland Diseases
Autonomic Nervous System Diseases
Nervous System Diseases
Hyperhidrosis
Sweat Gland Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 20, 2014