Clinical trial NCT05452837: FDFG Versus SMAS Flap After Superficial Parotidectomy; Evaluation of Functional and Esthetic Outcome
Official title: Free Dermal Fat Graft (FDFG) Versus Superficial Musculoaponeurotic System (SMAS) Flap After Superficial Parotidectomy; Evaluation of Functional and Esthetic Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frey Syndrome
Keywords: Frey's syndrome
Postparotidectomy reconstruction
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* Patients indicated for superficial parotidectomy

Exclusion Criteria:

* Less than 18 years of age
* Proved malignant parotid tumor

Primary outcomes:
measure: Number of patients with Frey's syndrome
timeFrame: 6 months
Secondary outcomes:
measure: Degree of patients' satisfaction with the fascial symmetry
timeFrame: 6 months
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Faculty of Medicine, Menoufia University
Study officials:
affiliation: Faculty of Medicine, Menoufia University
name: M. Ashraf Balbaa, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Curry JM, King N, Reiter D, Fisher K, Heffelfinger RN, Pribitkin EA. Meta-analysis of surgical techniques for preventing parotidectomy sequelae. Arch Facial Plast Surg. 2009 Sep-Oct;11(5):327-31. doi: 10.1001/archfacial.2009.62.