Back to results

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

Primary Purpose

Parotid Tumor

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

ADM

About this trial

This is an interventional prevention trial for Parotid Tumor focused on measuring human acellular dermal matrix, parotid tumor, total parotidectomy

Eligibility Criteria

10 Years - 79 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

West China Hospital of Stomatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ADM group

control group

Arm Description

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

41 patients (control group) had a total parotidectomy alone

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01414790

First Posted

August 10, 2011

Last Updated

August 10, 2011

Sponsor

West China Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01414790

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

West China Hospital

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parotid Tumor

Keywords

human acellular dermal matrix, parotid tumor, total parotidectomy

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ADM group

Arm Type

Experimental

Arm Description

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

Arm Title

control group

Arm Type

No Intervention

Arm Description

41 patients (control group) had a total parotidectomy alone

Intervention Type

Procedure

Intervention Name(s)

ADM

Other Intervention Name(s)

Acellular dermal matrix

Intervention Description

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

Primary Outcome Measure Information:

Title

infraauricular depressed deformities and the presence of gustatory flushing or sweating

Description

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

Time Frame

from 6 months to 7 years after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wen Luo, DMD

Organizational Affiliation

West China Hospital of Stomatology

Official's Role

Study Chair

Facility Information:

Facility Name

West China Hospital of Stomatology

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

12533152

Citation

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.

Results Reference

result

Learn more about this trial

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

We'll reach out to this number within 24 hrs