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

Parotid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414790
• Other study ID #: luowen228
• Status: Completed
• Phase: Phase 3
• First received: August 10, 2011
• Last updated: August 10, 2011
• Start date: January 2004
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 79 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Parotid Neoplasms
• Parotid Tumor

Intervention

Procedure:
• ADM
29 patients (ADM group) had a total parotidectomy with a simultaneous ADM implantation

Locations

Country	Name	City	State
China	West China Hospital of Stomatology	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   The West China Hospital of Stomatology has long been ranked as one of the nation's top hospitals in China.