Reconstruction of Maxillary and Midfacial Defects Using Latissimus Dorsi Scapular Free Flaps

Maxillary Neoplasms Clinical Trial

Official title:

Reconstruction of Maxillary and Midfacial Defects Using Latissimus Dorsi Scapular Free Flaps

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04522700
• Other study ID #: scapular free flaps
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 25, 2020
• Est. completion date: October 2025

Study information

• Verified date: September 2020
• Source: Assiut University
• Contact: hassan harby
• Phone: 0101261001
• Email: harby1990hassan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bony reconstruction of the midface with free tissue transfer is complex and challenging due to structural considerations such as the need for orbital support, patency of the nasal cavity, restoration of the palate and alveolus and skull base support when needed. As a result, bony reconstruction is important especially for patients who experience diplopia, hypoglobus and enophthalmos postoperatively.

Orocutaneous and nasocutaneous fistulae and infection due to communication with the oral cavity or sinuses are also common complication . Finally, cosmetic deformities from inadequate projection are also a concern.

Cosmetic and functional outcomes are improved with bony reconstruction as it is able to provide rigid support of key structures, restoration of contour, affords the possibility of dental rehabilitation and is less likely to contract significantly following radiation treatment.

Subscapular system free flaps (SF) are uniquely suited to address the needs of midface reconstruction. A substantial amount of bone can be harvested from the lateral scapular border and scapular tip, each with different shapes and thicknesses. Chimeric flaps can be harvested in various combinations, adding Para scapular and scapular skin paddles, latissimus muscle (with or without skin), serratus muscle and rib. Additionally, due to the vascular organization of this network, these components can be harvested off separate pedicles, offering great flexibility and freedom of movement relative to each other .

Description:

reconstruction of defects post maxiilectomy by scapular free flaps

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 75 Years

Eligibility

Inclusion Criteria:

1. All patients post maxillectomy due to benign maxillary lesions.

2. All patients post maxillectomy with malignant maxillary swelling with no distant metastases.

3. All patients which implants are needed after surgery for head and neck neoplasia .

Exclusion Criteria:

1. Oropharyngeal, Nasopharyngeal, and Hypopharyngeal cancers, and lip cancers;.

2. Recurrent tumors resulting in implant loss.

3. Previous free flap harvest from scapula.

Related Conditions & MeSH terms

• Maxillary Neoplasms

Intervention

Procedure:
• scapular free flap
use of scapular free flap to reconstruction post maxillectomy defect to provide bony support

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
hassan harby mohamed

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Sarukawa S, Kamochi H, Noguchi T, Sunaga A, Uda H, Mori Y, Nishino H, Yoshimura K. Free-flap surgical correction of facial deformity after anteromedial maxillectomy. J Craniomaxillofac Surg. 2017 Sep;45(9):1573-1577. doi: 10.1016/j.jcms.2017.06.020. Epub 2017 Jul 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reconstruction and restoration of facial contour.	reconstruction of the maxilla by provide rigid bony support post maxillectomy with measurement of graft taken and union occur by follow up with MSCT of the facial bone with 3D film .	6 month