FDFG Versus SMAS Flap After Superficial Parotidectomy; Evaluation of Functional and Esthetic Outcome
NCT ID: NCT05452837
Last Updated: 2022-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
78 participants
INTERVENTIONAL
2016-02-01
2021-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Free Dermal Fat Graft
Free Dermal Fat Graft (FDFG) is applied to the superficial parotidectomy defect site
FDFG
FDFG is applied to the parotidectomy bed after superficial parotidectomy
Superficial musculoaponeurotic system flap
Superficial musculoaponeurotic system (SMAS) Flap is dissected and tailored to fill the defect after superficial parotidectomy
SMAS
SMAS flap is applied to the parotidectomy bed after superficial parotidectomy
Interventions
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FDFG
FDFG is applied to the parotidectomy bed after superficial parotidectomy
SMAS
SMAS flap is applied to the parotidectomy bed after superficial parotidectomy
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Proved malignant parotid tumor
18 Years
ALL
No
Sponsors
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Menoufia University
OTHER
Responsible Party
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M. Ashraf Balbaa
Professor of Surgery
Principal Investigators
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M. Ashraf Balbaa, M.D.
Role: PRINCIPAL_INVESTIGATOR
Faculty of Medicine, Menoufia University
Locations
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Faculty of Medicine, Menoufia University
Shibīn al Kawm, , Egypt
Countries
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References
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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.
Fawzy A, Balbaa MA, Hagag M. Evaluation of functional and aesthetic outcomes of free dermal fat graft versus superficial musculoaponeurotic system flap after superficial parotidectomy: randomized clinical trial. BJS Open. 2023 May 5;7(3):zrac173. doi: 10.1093/bjsopen/zrac173.
Other Identifiers
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7/2022SURG3B
Identifier Type: -
Identifier Source: org_study_id
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