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

Sponsor
Menoufia University (Other)
Overall Status
Completed
CT.gov ID
NCT05452837
Collaborator
(none)
78
1
2
69
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: FDFG
  • Procedure: SMAS
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
78 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Free Dermal Fat Graft (FDFG) Versus Superficial Musculoaponeurotic System (SMAS) Flap After Superficial Parotidectomy; Evaluation of Functional and Esthetic Outcome
Actual Study Start Date :
Feb 1, 2016
Actual Primary Completion Date :
Oct 1, 2021
Actual Study Completion Date :
Oct 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Free Dermal Fat Graft

Free Dermal Fat Graft (FDFG) is applied to the superficial parotidectomy defect site

Procedure: FDFG
FDFG is applied to the parotidectomy bed after superficial parotidectomy

Active Comparator: Superficial musculoaponeurotic system flap

Superficial musculoaponeurotic system (SMAS) Flap is dissected and tailored to fill the defect after superficial parotidectomy

Procedure: SMAS
SMAS flap is applied to the parotidectomy bed after superficial parotidectomy

Outcome Measures

Primary Outcome Measures

  1. Number of patients with Frey's syndrome [6 months]

    Number of patients who developed of Frey's syndrome as post-parotidectomy complication

Secondary Outcome Measures

  1. Degree of patients' satisfaction with the fascial symmetry [6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients indicated for superficial parotidectomy
Exclusion Criteria:
  • Less than 18 years of age

  • Proved malignant parotid tumor

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Medicine, Menoufia University Shibīn Al Kawm Egypt

Sponsors and Collaborators

  • Menoufia University

Investigators

  • Principal Investigator: M. Ashraf Balbaa, M.D., Faculty of Medicine, Menoufia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
M. Ashraf Balbaa, Professor of Surgery, Menoufia University
ClinicalTrials.gov Identifier:
NCT05452837
Other Study ID Numbers:
  • 7/2022SURG3B
First Posted:
Jul 11, 2022
Last Update Posted:
Jul 14, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by M. Ashraf Balbaa, Professor of Surgery, Menoufia University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 14, 2022