- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05828771
Outcomes and Clinical Applications of Thin Free Flaps for Soft Tissue Defects
April 12, 2023 updated by: Ahmed Mahmoud Mohamed Abdellatif, Sohag University
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 Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ahmed m abdellatif, assistant lecturer
- Phone Number: 01110932389
- Email: ahmed.abdellatief@med.sohag.edu.eg
Study Contact Backup
- Name: samia m saied, professor
Study Locations
-
-
-
Sohag, Egypt
- Sohag University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
June 1, 2023
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
April 12, 2023
First Submitted That Met QC Criteria
April 12, 2023
First Posted (Actual)
April 25, 2023
Study Record Updates
Last Update Posted (Actual)
April 25, 2023
Last Update Submitted That Met QC Criteria
April 12, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- soh-Med-23-04-02MD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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