Frey SyndromeNCT05452837
FDFG Versus SMAS Flap After Superficial Parotidectomy; Evaluation of Functional and Esthetic Outcome
A study testing FDFG and SMAS in people with Frey Syndrome, run by Menoufia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frey Syndrome
- What is being tested?
- FDFG and SMAS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2016to 31 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients indicated for superficial parotidectomy
Who cannot join
- Less than 18 years of age
- Proved malignant parotid tumor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Free Dermal Fat Graft (FDFG) Versus Superficial Musculoaponeurotic System (SMAS) Flap After Superficial Parotidectomy; Evaluation of Functional and Esthetic Outcome
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.
Read the 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.
- Conditions
- Frey Syndrome
- Being tested
- FDFG, SMAS
- Keywords
- Frey's syndrome, Postparotidectomy reconstruction
- Medical subject headings
- Sweating, Gustatory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDFGProcedure or surgery
FDFG is applied to the parotidectomy bed after superficial parotidectomy
SMASProcedure or surgery
SMAS flap is applied to the parotidectomy bed after superficial parotidectomy
| Study group | Role | What they receive |
|---|---|---|
| Free Dermal Fat Graft | Active comparator | Free Dermal Fat Graft (FDFG) is applied to the superficial parotidectomy defect site Receives: Procedure: FDFG |
| Superficial musculoaponeurotic system flap | Active comparator | Superficial musculoaponeurotic system (SMAS) Flap is dissected and tailored to fill the defect after superficial parotidectomy Receives: Procedure: SMAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with Frey's syndrome
Number of patients who developed of Frey's syndrome as post-parotidectomy complication
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start1 Feb 2016
- Primary completion1 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Frey SyndromeStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M. Ashraf Balbaa, Menoufia University
- Investigators
- M. Ashraf Balbaa, M.D., Principal investigator, Faculty of Medicine, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452837
- Sponsor's protocol ID
- 7/2022SURG3B
- Status last verified
- Jul 2022
- First submitted
- 16 Jun 2022
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol will be available to be shared on request after study publication for 6 months.
Publications
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.
PubMed 19797095Fawzy 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.
PubMed 37151084
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Free Dermal Fat Graft (FDFG) Versus Superficial Musculoaponeurotic System (SMAS) Flap After Superficial Parotidectomy; Evaluation of Functional and Esthetic Outcome
- ClinicalTrials.gov ID
- NCT05452837
- Acronym / sponsor ID
- 7/2022SURG3B
- Conditions
- Frey Syndrome
- Keywords
- Frey's syndrome, Postparotidectomy reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Free Dermal Fat Graft | Active comparator | Procedure: FDFGFree Dermal Fat Graft (FDFG) is applied to the superficial parotidectomy defect site |
| Superficial musculoaponeurotic system flap | Active comparator | Procedure: SMASSuperficial musculoaponeurotic system (SMAS) Flap is dissected and tailored to fill the defect after superficial parotidectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients indicated for superficial parotidectomy
Key exclusion criteria (2 listed)
- Less than 18 years of age
- Proved malignant parotid tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FDFGFDFG is applied to the parotidectomy bed after superficial parotidectomy | Procedure or surgery | Free Dermal Fat Graft |
| SMASSMAS flap is applied to the parotidectomy bed after superficial parotidectomy | Procedure or surgery | Superficial musculoaponeurotic system flap |
Primary outcome
Number of patients with Frey's syndrome
Time frame: 6 months
Number of patients who developed of Frey's syndrome as post-parotidectomy complication
1 secondary outcome
Degree of patients' satisfaction with the fascial symmetry
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Results publication: PubMed 19797095Curry 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.
- Derived from this study: PubMed 37151084Fawzy 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.
- Individual participant dataSharing planned: Yes. Study protocol will be available to be shared on request after study publication for 6 months.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Ashraf Balbaa, M.D. principal investigator
Faculty of Medicine, Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDFG and SMAS in people with Frey Syndrome, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with Frey's syndrome (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05452837, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.