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


Phase 3
10 Years
79 Years
Not Enrolling
Both
Parotid Tumor

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

infraauricular depressed deformities and the presence of gustatory flushing or sweating

Outcome Description:

to explore whether human acellular dermal matrix (ADM) implantation could prevent infraauricular depressed deformities and Frey's syndrome following total parotidectomy

Outcome Time Frame:

from 6 months to 7 years after surgery

Safety Issue:

Yes

Principal Investigator

Wen Luo, DMD

Investigator Role:

Study Chair

Investigator Affiliation:

West China Hospital of Stomatology

Authority:

China: Food and Drug Administration

Study ID:

luowen228

NCT ID:

NCT01414790

Start Date:

January 2004

Completion Date:

January 2011

Related Keywords:

  • Parotid Tumor
  • human acellular dermal matrix
  • parotid tumor
  • total parotidectomy
  • Parotid Neoplasms
  • Sweating, Gustatory

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