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

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ClinicalTrials.gov Identifier: NCT01414790
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : August 11, 2011
Sponsor:
Information provided by:
West China Hospital

Tracking Information
First Submitted Date  ICMJE August 10, 2011
First Posted Date  ICMJE August 11, 2011
Last Update Posted Date August 11, 2011
Study Start Date  ICMJE January 2004
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2011)
infraauricular depressed deformities and the presence of gustatory flushing or sweating [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of Human Acellular Dermal Matrix to Improve Infraauricular Depressed Deformities and Frey's Syndrome
Official Title  ICMJE The Use of Human Acellular Dermal Matrix in the Prevention of Infraauricular Depressed Deformities and Frey's Syndrome Following Total Parotidectomy
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Parotid Tumor
Intervention  ICMJE Procedure: ADM
29 patients (ADM group) had a total parotidectomy with a simultaneous ADM implantation
Other Name: Acellular dermal matrix
Study Arms  ICMJE
  • Experimental: ADM group
    29 patients (ADM group) had a total parotidectomy with a simultaneous ADM implantation
    Intervention: Procedure: ADM
  • No Intervention: control group
    41 patients (control group) had a total parotidectomy alone
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2011)
70
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2011
Actual Primary Completion Date January 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 79 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01414790
Other Study ID Numbers  ICMJE luowen228
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party West China Hospital of Stomatology
Study Sponsor  ICMJE West China Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Wen Luo, DMD West China Hospital of Stomatology
PRS Account West China Hospital
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP