Outcomes and Clinical Applications of Thin Free Flaps for Soft Tissue Defects

SOFT TISSUE DEFECTS Clinical Trial

Official title:

Outcomes and Clinical Applications of Thin Free Flaps for Soft Tissue Defects

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05828771
• Other study ID #: soh-Med-23-04-02MD
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: December 2023

Study information

• Verified date: April 2023
• Source: Sohag University
• Contact: ahmed m abdellatif, assistant lecturer
• Phone: 01110932389
• Email: ahmed.abdellatief[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• SOFT TISSUE DEFECTS

Intervention

Procedure:
• THIN FREE FLAP
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

Locations

Country	Name	City	State
Egypt	Sohag University Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

Garg 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. — View Citation

Glass 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. — View Citation

Goh 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months