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

• Sponsor: West China Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01414790
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Duration (Months): 84
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Parotid Tumor	Procedure: ADM	Phase 3

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Use of Human Acellular Dermal Matrix in the Prevention of Infraauricular Depressed Deformities and Frey's Syndrome Following Total Parotidectomy
• Study Start Date: Jan 1, 2004
• Actual Primary Completion Date: Jan 1, 2011
• Actual Study Completion Date: Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ADM group 29 patients (ADM group) had a total parotidectomy with a simultaneous ADM implantation	Procedure: ADM; 29 patients (ADM group) had a total parotidectomy with a simultaneous ADM implantation; Other Names: Acellular dermal matrix
No Intervention: control group 41 patients (control group) had a total parotidectomy alone

Outcome Measures

Primary Outcome Measures

1. infraauricular depressed deformities and the presence of gustatory flushing or sweating [from 6 months to 7 years after surgery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West China Hospital of Stomatology	Chengdu	Sichuan	China	610041

Sponsors and Collaborators

• West China Hospital

Investigators

• Study Chair: Wen Luo, DMD, West China Hospital of Stomatology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01414790
• Other Study ID Numbers: luowen228
• First Posted: Aug 11, 2011
• Last Update Posted: Aug 11, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: human acellular dermal matrix; parotid tumor; total parotidectomy
• Additional relevant MeSH terms: Parotid Neoplasms; Sweating, Gustatory

Study Results

No Results Posted as of Aug 11, 2011