Clinical trial NCT04522700: Reconstruction of Maxillary and Midfacial Defects Using Latissimus Dorsi Scapular Free Flaps
Official title: Reconstruction of Maxillary and Midfacial Defects Using Latissimus Dorsi Scapular Free Flaps
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Maxillary Neoplasms
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 30
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 .

Detailed description: reconstruction of defects post maxiilectomy by scapular free flaps

Eligibility criteria: 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.

Primary outcomes:
measure: reconstruction and restoration of facial contour.
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Assiut University
name: hassan harby
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.