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

NCT05452837 | Completed

• 1 other identifier: 7/2022SURG3B
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Frey Syndrome

Keywords

Frey's syndrome; Postparotidectomy reconstruction

Outcome Measures

Primary Outcomes (1)

• Number of patients with Frey's syndrome

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

  6 months

Secondary Outcomes (1)

• Degree of patients' satisfaction with the fascial symmetry

  6 months

Study Arms (2)

Free Dermal Fat Graft

ACTIVE COMPARATOR

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

Procedure: FDFG

Superficial musculoaponeurotic system flap

ACTIVE COMPARATOR

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

Procedure: SMAS

Interventions

FDFG PROCEDURE

FDFG is applied to the parotidectomy bed after superficial parotidectomy

Free Dermal Fat Graft

SMAS PROCEDURE

SMAS flap is applied to the parotidectomy bed after superficial parotidectomy

Superficial musculoaponeurotic system flap

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients indicated for superficial parotidectomy

You may not qualify if:

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

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Faculty of Medicine, Menoufia University

Shibīn al Kawm, Egypt

Location

Related Publications (2)

• 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.

  PMID: 19797095 RESULT

• 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.

  PMID: 37151084 DERIVED

MeSH Terms

Conditions

Sweating, Gustatory

Condition Hierarchy (Ancestors)

Autonomic Nervous System Diseases; Nervous System Diseases; Hyperhidrosis; Sweat Gland Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• M. Ashraf Balbaa, M.D.

  Faculty of Medicine, Menoufia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: July 11, 2022
• Study Start: February 1, 2016
• Primary Completion: October 1, 2021
• Study Completion: October 31, 2021
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Six months from the time of study publication
• Access Criteria: Contacting the corresponding author

Locations

EG (1)