The Use of Human Acellular Dermal Matrix in the Prevention of Infraauricular Depressed Deformities and Frey's Syndrome Following Total Parotidectomy
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
infraauricular depressed deformities and the presence of gustatory flushing or sweating
to explore whether human acellular dermal matrix (ADM) implantation could prevent infraauricular depressed deformities and Frey's syndrome following total parotidectomy
from 6 months to 7 years after surgery
Yes
Wen Luo, DMD
Study Chair
West China Hospital of Stomatology
China: Food and Drug Administration
luowen228
NCT01414790
January 2004
January 2011
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