The Use of Human Acellular Dermal Matrix to Improve Infraauricular Depressed Deformities and Frey's Syndrome
NCT ID: NCT01414790
Last Updated: 2011-08-11
Study Results
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Basic Information
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COMPLETED
PHASE3
70 participants
INTERVENTIONAL
2004-01-31
2011-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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ADM group
29 patients (ADM group) had a total parotidectomy with a simultaneous ADM implantation
ADM
29 patients (ADM group) had a total parotidectomy with a simultaneous ADM implantation
control group
41 patients (control group) had a total parotidectomy alone
No interventions assigned to this group
Interventions
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ADM
29 patients (ADM group) had a total parotidectomy with a simultaneous ADM implantation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* (2) no previous surgical treatment
Exclusion Criteria
10 Years
79 Years
ALL
No
Sponsors
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West China Hospital
OTHER
Responsible Party
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West China Hospital of Stomatology
Principal Investigators
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Wen Luo, DMD
Role: STUDY_CHAIR
West China Hospital of Stomatology
Locations
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West China Hospital of Stomatology
Chengdu, Sichuan, China
Countries
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References
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Sinha UK, Saadat D, Doherty CM, Rice DH. Use of AlloDerm implant to prevent frey syndrome after parotidectomy. Arch Facial Plast Surg. 2003 Jan-Feb;5(1):109-12. doi: 10.1001/archfaci.5.1.109.
Other Identifiers
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luowen228
Identifier Type: -
Identifier Source: org_study_id
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