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

NCT ID: NCT01414790

Last Updated: 2011-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2011-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Parotid Tumor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ADM group

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

Group Type EXPERIMENTAL

ADM

Intervention Type PROCEDURE

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

control group

41 patients (control group) had a total parotidectomy alone

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ADM

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

Intervention Type PROCEDURE

Other Intervention Names

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Acellular dermal matrix

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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West China Hospital of Stomatology

Principal Investigators

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Wen Luo, DMD

Role: STUDY_CHAIR

West China Hospital of Stomatology

Locations

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West China Hospital of Stomatology

Chengdu, Sichuan, China

Site Status

Countries

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China

References

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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. doi: 10.1001/archfaci.5.1.109.

Reference Type RESULT
PMID: 12533152 (View on PubMed)

Other Identifiers

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luowen228

Identifier Type: -

Identifier Source: org_study_id

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