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

Sponsor
hassan harby mohamed (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04522700
Collaborator
(none)
30
1
60.2
0.5

Study Details

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 .

Condition or Disease Intervention/Treatment Phase
  • Procedure: scapular free flap
N/A

Detailed Description

reconstruction of defects post maxiilectomy by scapular free flaps

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Reconstruction of Maxillary and Midfacial Defects Using Latissimus Dorsi Scapular Free Flaps
Anticipated Study Start Date :
Sep 25, 2020
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Oct 1, 2025

Outcome Measures

Primary Outcome Measures

  1. reconstruction and restoration of facial contour. [6 month]

    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 .

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Assiut University Assiut Egypt 71511

Sponsors and Collaborators

  • hassan harby mohamed

Investigators

  • Principal Investigator: hassan harby, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
hassan harby mohamed, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT04522700
Other Study ID Numbers:
  • scapular free flaps
First Posted:
Aug 21, 2020
Last Update Posted:
Sep 16, 2020
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2020