NCT01414790

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2004

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
Last Updated

August 11, 2011

Status Verified

January 1, 2011

Enrollment Period

7 years

First QC Date

August 10, 2011

Last Update Submit

August 10, 2011

Conditions

Parotid Tumor

Keywords

human acellular dermal matrixparotid tumortotal parotidectomy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

ADM group

EXPERIMENTAL

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

Procedure: ADM

control group

NO INTERVENTION

41 patients (control group) had a total parotidectomy alone

Interventions

ADMPROCEDURE

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

Also known as: Acellular dermal matrix
ADM group

Eligibility Criteria

Age10 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • (1) a clinical and imaging diagnosis of either a malignant parotid tumor or deep parotid tumor
  • (2) no previous surgical treatment

You may not qualify if:

  • recurrent parotid tumors or patients who had previously undergone unsuccessful surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital of Stomatology

Chengdu, Sichuan, 610041, China

Location

Related 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. doi: 10.1001/archfaci.5.1.109.

    PMID: 12533152RESULT

MeSH Terms

Conditions

Parotid Neoplasms

Condition Hierarchy (Ancestors)

Salivary Gland NeoplasmsMouth NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesParotid DiseasesSalivary Gland Diseases

Study Officials

  • Wen Luo, DMD

    West China Hospital of Stomatology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 10, 2011

First Posted

August 11, 2011

Study Start

January 1, 2004

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

August 11, 2011

Record last verified: 2011-01

Locations

CN(1)