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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

August 10, 2011
August 10, 2011
January 2004
January 2011   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
Not Provided
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Not Provided
Not Provided
 
The Use of Human Acellular Dermal Matrix to Improve Infraauricular Depressed Deformities and Frey's Syndrome
The Use of Human Acellular Dermal Matrix in the Prevention of Infraauricular Depressed Deformities and Frey's Syndrome Following Total Parotidectomy

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.

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
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Parotid Tumor
Procedure: ADM
29 patients (ADM group) had a total parotidectomy with a simultaneous ADM implantation
Other Name: Acellular dermal matrix
  • Experimental: ADM group
    29 patients (ADM group) had a total parotidectomy with a simultaneous ADM implantation
    Intervention: Procedure: ADM
  • No Intervention: control group
    41 patients (control group) had a total parotidectomy alone
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
10 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01414790
luowen228
Yes
West China Hospital of Stomatology
West China Hospital
Not Provided
Study Chair: Wen Luo, DMD West China Hospital of Stomatology
West China Hospital
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP