Clinical trial · Interventional
The Use of Human Acellular Dermal Matrix to Improve Infraauricular Depressed Deformities and Frey's Syndrome
The Use of Human Acellular Dermal Matrix in the Prevention of Infraauricular Depressed Deformities and Frey's Syndrome Following Total Parotidectomy
NCT01414790CI-TRIAL-00005349completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Parotid Tumor | Parotid Gland Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADM | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ADM group
- description
- 29 patients (ADM group) had a total parotidectomy with a simultaneous ADM implantation
- interventionNames
- Procedure: ADM
- type
- NO_INTERVENTION
- label
- control group
- description
- 41 patients (control group) had a total parotidectomy alone
Primary outcomes (1)
- measure
- infraauricular depressed deformities and the presence of gustatory flushing or sweating
- timeFrame
- from 6 months to 7 years after surgery
- description
- to explore whether human acellular dermal matrix (ADM) implantation could prevent infraauricular depressed deformities and Frey's syndrome following total parotidectomy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTSinha 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 12533152