NCT05828771

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

6 months

First QC Date

April 12, 2023

Last Update Submit

April 12, 2023

Conditions

SOFT TISSUE DEFECTS

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

THIN FREE FLAPPROCEDURE

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

Eligibility Criteria

Age5 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related 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.

    PMID: 12045538BACKGROUND

  • 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.

    PMID: 27658935BACKGROUND

  • 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.

    PMID: 36163147BACKGROUND

  • 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.

    PMID: 25357163BACKGROUND

Central Study Contacts

ahmed m abdellatif, assistant lecturer

CONTACT

01110932389ahmed.abdellatief@med.sohag.edu.eg

samia m saied, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturar at plastic surgery department

Study Record Dates

First Submitted

April 12, 2023

First Posted

April 25, 2023

Study Start

June 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

April 25, 2023

Record last verified: 2023-04

Locations

EG(1)