FDFG Versus SMAS Flap After Superficial Parotidectomy; Evaluation of Functional and Esthetic Outcome

Study Overview
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Brief Summary
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After parotidectomy, Frey's syndrome and facial disfigurement are the most common encountered complications. Free dermal fat graft (FDFG) and the superficial musculoaponeurotic system (SMAS) flap, have very promising results. In this study, the functional and esthetic outcome from their usage were compared.

Detailed Description
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Parotidectomy is the standard procedure for treatment of many parotid lesions, however it carries a lot of drawbacks. Facial asymmetry and Frey's syndrome are the most annoying complications to the patients. Insertion of inter-positioning grafts at parotidectomy bed can decrease these complications significantly. Free dermal fat graft (FDFG) and the superficial musculoaponeurotic system (SMAS) flap, have very promising results. In this study the investigators have compared the functional and esthetic outcome from their usage. Seventy-eight patient underwent parotidectomy for various causes. The patients were divided randomly in 2 groups each group 39 patients. In one group FDFG was inserted at the parotidectomy bed, while in the other group SMAS flap was performed. Preoperative, operative, and postoperative data were recorded and analyzed. The normality of distribution of variables was verified by Wilks -Shapiro test. The data were expressed as Number (No), percentage (%) mean (x̅) and standard deviation (SD). Chi-square test (χ2) was used to study association between qualitative variables. Whenever any of the expected cells were less than five, Fischer's Exact test was used. Student's t-test is a test of significance used for comparison of quantitative variables between two groups of normally distributed data, while Mann Whitney's test was used for comparison of quantitative variables between two groups of not normally distributed data. Two-sided P value was set to be significant if < 0.05.

Official Title
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Free Dermal Fat Graft (FDFG) Versus Superficial Musculoaponeurotic System (SMAS) Flap After Superficial Parotidectomy; Evaluation of Functional and Esthetic Outcome

Conditions
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Frey Syndrome

Intervention / Treatment
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* Procedure: FDFG
* Procedure: SMAS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients indicated for superficial parotidectomy Exclusion Criteria: Less than 18 years of age Proved malignant parotid tumor

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Free Dermal Fat Graft<br>Free Dermal Fat Graft (FDFG) is applied to the superficial parotidectomy defect site | Procedure: FDFG<br>* FDFG is applied to the parotidectomy bed after superficial parotidectomy<br>|
| Active Comparator: Superficial musculoaponeurotic system flap<br>Superficial musculoaponeurotic system (SMAS) Flap is dissected and tailored to fill the defect after superficial parotidectomy | Procedure: SMAS<br>* SMAS flap is applied to the parotidectomy bed after superficial parotidectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Frey's syndrome | Number of patients who developed of Frey's syndrome as post-parotidectomy complication | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of patients' satisfaction with the fascial symmetry | Assessment of degree of patients' satisfaction of the esthetic outcome after parotidectomy regarding post parotidectomy facial symmetry based on a verbal descriptive scale; excellent, good, fair, and poor. It is not based on numerical scale. Number of patients who will have excellent, good, fair or poor response will be recorded and compared within the two groups. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frey's syndrome, Postparotidectomy reconstruction