SOFT TISSUE DEFECTSNCT05828771
Outcomes and Clinical Applications of Thin Free Flaps for Soft Tissue Defects
A study testing THIN FREE FLAP in people with SOFT TISSUE DEFECTS, run by Sohag University at 1 site in Egypt.
Trial summary
Flap coverage is often required to achieve primary wound closure and to achieve a good functional result. Free flap has gain popularity over random flap in soft tissue reconstruction to achive maximal cosmetic and functional outcome. Read more about this study
- Who is it for?
- Ages 5 to 65 years
- Conditions the study is for
- SOFT TISSUE DEFECTS
- What is being tested?
- THIN FREE FLAP
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2023to Dec 2023
- 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 5 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with soft tissue defects in different body regions who are prepared for free flap surgery. All patients under 65 year of age and above 5 years of age.
Who cannot join
- Patient who is not indicated for free flap. Patient above 65 year of age and below five year of age. Severely ill patient or with vascular problem or unfit for surgery.
Trial locations and contacts
1 site in 1 country.
samia m saied, professor contact
About this study
Flap coverage is often required to achieve primary wound closure and to achieve a good functional result. Free flap has gain popularity over random flap in soft tissue reconstruction to achive maximal cosmetic and functional outcome. Advances in reconstructive techniques have widened the application of free flap tissue transfer for repair of head and neck defects and have resulted in improved quality of life and both functional and aesthetic outcomes. Interference of high technology like CT Angio and Duplex ultra sound makes perforator detection more easy and more accurate. Fasciocutaneous free flaps raised in the traditional sub or supra-fascial planes can sometimes be thick and bulky. Elevating thin flaps has long been a goal of reconstructive surgeons. Thin flaps have numerous advantages in reconstruction. Thin flap is required in aesthetically significant areas, such as in fascial and hand reconstruction. In addition to their aesthetic importance, thin flaps are frequently required due to functional considerations. In head and neck reconstruction, bulky flaps may interfere with smooth swallowing and cause airway obstruction. In adition resurfacing of joint exposure require thin flap to maintain maximum joint function. Donor site shows better outcomes with thin free flap due to preservation of deep fatty layer that decrease the incidence of donor site neuroma and better countour when application of skin graft.
- Conditions
- SOFT TISSUE DEFECTS
- Being tested
- THIN FREE FLAP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THIN FREE FLAPProcedure or surgery
Flap design will be performed on the basis of the preoperative perforator mapping. Freestyle flap elevation will be performed under loupe magnification from one of the incisions until the perforators are reached
What is being measured
The primary outcome is the main question the study is designed to answer.
SUCEES RATE AND POTENTIAL COVERAGE
This study is designed for the clinical applications of thin free flaps regarding their coverage potential, dissection procedure and their outcomes (success and complications) as a reconstructive option
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 posted25 Apr 2023
- Study startJun 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SOFT TISSUE DEFECTSStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahmoud Mohamed Abdellatif, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828771
- Sponsor's protocol ID
- soh-Med-23-04-02MD
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Celik N, Wei FC, Lin CH, Cheng MH, Chen HC, Jeng SF, Kuo YR. Technique and strategy in anterolateral thigh perforator flap surgery, based on an analysis of 15 complete and partial failures in 439 cases. Plast Reconstr Surg. 2002 Jun;109(7):2211-6; discussion 2217-8. doi: 10.1097/00006534-200206000-00005.
PubMed 12045538Garg RK, Wieland AM, Hartig GK, Poore SO. Risk factors for unplanned readmission following head and neck microvascular reconstruction: Results from the National Surgical Quality Improvement Program, 2011-2014. Microsurgery. 2017 Sep;37(6):502-508. doi: 10.1002/micr.30116. Epub 2016 Sep 23.
PubMed 27658935Glass GE, Staruch RM, Sivakumar B, Stotland MA. Thin and superthin free flaps: An innovative approach to pediatric extremity reconstruction. J Plast Reconstr Aesthet Surg. 2022 Nov;75(11):3970-3978. doi: 10.1016/j.bjps.2022.06.090. Epub 2022 Jun 28.
PubMed 36163147Goh TLH, Park SW, Cho JY, Choi JW, Hong JP. The search for the ideal thin skin flap: superficial circumflex iliac artery perforator flap--a review of 210 cases. Plast Reconstr Surg. 2015 Feb;135(2):592-601. doi: 10.1097/PRS.0000000000000951.
PubMed 25357163
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes and Clinical Applications of Thin Free Flaps for Soft Tissue Defects
- ClinicalTrials.gov ID
- NCT05828771
- Acronym / sponsor ID
- soh-Med-23-04-02MD
- Conditions
- SOFT TISSUE DEFECTS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 25 Apr 2023 (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.
Flap coverage is often required to achieve primary wound closure and to achieve a good functional result. Free flap has gain popularity over random flap in soft tissue reconstruction to achive maximal cosmetic and functional outcome. Advances in reconstructive techniques have widened the application of free flap tissue transfer for repair of head and neck defects and have resulted in improved quality of life and both functional and aesthetic outcomes. Interference of high technology like CT Angio and Duplex ultra sound makes perforator detection more easy and more accurate. Fasciocutaneous free flaps raised in the traditional sub or supra-fascial planes can sometimes be thick and bulky. Elevating thin flaps has long been a goal of reconstructive surgeons. Thin flaps have numerous advantages in reconstruction. Thin flap is required in aesthetically significant areas, such as in fascial and hand reconstruction. In addition to their aesthetic importance, thin flaps are frequently required due to functional considerations. In head and neck reconstruction, bulky flaps may interfere with smooth swallowing and cause airway obstruction. In adition resurfacing of joint exposure require thin flap to maintain maximum joint function. Donor site shows better outcomes with thin free flap due to preservation of deep fatty layer that decrease the incidence of donor site neuroma and better countour when application of skin graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with soft tissue defects in different body regions who are prepared for free flap surgery. All patients under 65 year of age and above 5 years of age.
Key exclusion criteria (1 listed)
- Patient who is not indicated for free flap. Patient above 65 year of age and below five year of age. Severely ill patient or with vascular problem or unfit for surgery.
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 |
|---|---|---|
| THIN FREE FLAPFlap design will be performed on the basis of the preoperative perforator mapping. Freestyle flap elevation will be performed under loupe magnification from one of the incisions until the perforators are reached | Procedure or surgery | – |
Primary outcome
SUCEES RATE AND POTENTIAL COVERAGE
Time frame: 6 months
This study is designed for the clinical applications of thin free flaps regarding their coverage potential, dissection procedure and their outcomes (success and complications) as a reconstructive option
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Background: PubMed 12045538Celik N, Wei FC, Lin CH, Cheng MH, Chen HC, Jeng SF, Kuo YR. Technique and strategy in anterolateral thigh perforator flap surgery, based on an analysis of 15 complete and partial failures in 439 cases. Plast Reconstr Surg. 2002 Jun;109(7):2211-6; discussion 2217-8. doi: 10.1097/00006534-200206000-00005.
- Background: PubMed 27658935Garg RK, Wieland AM, Hartig GK, Poore SO. Risk factors for unplanned readmission following head and neck microvascular reconstruction: Results from the National Surgical Quality Improvement Program, 2011-2014. Microsurgery. 2017 Sep;37(6):502-508. doi: 10.1002/micr.30116. Epub 2016 Sep 23.
- Background: PubMed 36163147Glass GE, Staruch RM, Sivakumar B, Stotland MA. Thin and superthin free flaps: An innovative approach to pediatric extremity reconstruction. J Plast Reconstr Aesthet Surg. 2022 Nov;75(11):3970-3978. doi: 10.1016/j.bjps.2022.06.090. Epub 2022 Jun 28.
- Background: PubMed 25357163Goh TLH, Park SW, Cho JY, Choi JW, Hong JP. The search for the ideal thin skin flap: superficial circumflex iliac artery perforator flap--a review of 210 cases. Plast Reconstr Surg. 2015 Feb;135(2):592-601. doi: 10.1097/PRS.0000000000000951.
- Individual participant dataSharing planned: Undecided
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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.
samia m saied, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THIN FREE FLAP in people with SOFT TISSUE DEFECTS, run by Sohag 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 1 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: status not confirmed, as of the sponsor's last update on 25 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ahmed m abdellatif, assistant lecturer (01110932389, ahmed.abdellatief@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUCEES RATE AND POTENTIAL COVERAGE (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 NCT05828771, which also lists 4 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 25 Apr 2023.