Reconstruction of Maxillary and Midfacial Defects Using Latissimus Dorsi Scapular Free Flaps
Primary Purpose
Maxillary Neoplasms
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
scapular free flap
Sponsored by
About this trial
This is an interventional treatment trial for Maxillary Neoplasms
Eligibility Criteria
Inclusion Criteria:
- All patients post maxillectomy due to benign maxillary lesions.
- All patients post maxillectomy with malignant maxillary swelling with no distant metastases.
- All patients which implants are needed after surgery for head and neck neoplasia .
Exclusion Criteria:
- Oropharyngeal, Nasopharyngeal, and Hypopharyngeal cancers, and lip cancers;.
- Recurrent tumors resulting in implant loss.
- Previous free flap harvest from scapula.
Sites / Locations
- Assiut University
Outcomes
Primary Outcome Measures
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 .
Secondary Outcome Measures
Full Information
NCT ID
NCT04522700
First Posted
August 17, 2020
Last Updated
September 13, 2020
Sponsor
hassan harby mohamed
1. Study Identification
Unique Protocol Identification Number
NCT04522700
Brief Title
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
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 25, 2020 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
hassan harby mohamed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maxillary Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
scapular free flap
Intervention Description
use of scapular free flap to reconstruction post maxillectomy defect to provide bony support
Primary Outcome Measure Information:
Title
reconstruction and restoration of facial contour.
Description
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 .
Time Frame
6 month
10. Eligibility
Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients post maxillectomy due to benign maxillary lesions.
All patients post maxillectomy with malignant maxillary swelling with no distant metastases.
All patients which implants are needed after surgery for head and neck neoplasia .
Exclusion Criteria:
Oropharyngeal, Nasopharyngeal, and Hypopharyngeal cancers, and lip cancers;.
Recurrent tumors resulting in implant loss.
Previous free flap harvest from scapula.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hassan harby
Phone
0101261001
Email
harby1990hassan@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hassan harby
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
71511
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
28747264
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.
Results Reference
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Reconstruction of Maxillary and Midfacial Defects Using Latissimus Dorsi Scapular Free Flaps
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