The Use of Human Acellular Dermal Matrix to Improve Infraauricular Depressed Deformities and Frey's Syndrome
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Parotid Tumor |
Procedure: ADM |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 |
- 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
| Enrollment: | 70 |
| Study Start Date: | January 2004 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: Acellular dermal matrix
|
|
No Intervention: control group
41 patients (control group) had a total parotidectomy alone
|
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.
Eligibility| Ages Eligible for Study: | 10 Years to 79 Years |
| Genders Eligible for Study: | Both |
| 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 More Information
Additional Information:
Publications:
| Responsible Party: | West China Hospital of Stomatology |
| ClinicalTrials.gov Identifier: | NCT01414790 History of Changes |
| Other Study ID Numbers: | luowen228 |
| Study First Received: | August 10, 2011 |
| Last Updated: | August 10, 2011 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by West China Hospital:
|
human acellular dermal matrix parotid tumor total parotidectomy |
Additional relevant MeSH terms:
|
Parotid Neoplasms Sweating, Gustatory Salivary Gland Neoplasms Mouth Neoplasms Head and Neck Neoplasms Neoplasms by Site Neoplasms Mouth Diseases |
Stomatognathic Diseases Parotid Diseases Salivary Gland Diseases Autonomic Nervous System Diseases Nervous System Diseases Hyperhidrosis Sweat Gland Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013