NCT04522700

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 .

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 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

August 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 25, 2020

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

4.9 years

First QC Date

August 17, 2020

Last Update Submit

September 13, 2020

Conditions

Maxillary Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

scapular free flapPROCEDURE

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

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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 .

You may not qualify if:

  • Oropharyngeal, Nasopharyngeal, and Hypopharyngeal cancers, and lip cancers;.
  • Recurrent tumors resulting in implant loss.
  • Previous free flap harvest from scapula.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, 71511, Egypt

Location

Related 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.

    PMID: 28747264BACKGROUND

MeSH Terms

Conditions

Maxillary Neoplasms

Condition Hierarchy (Ancestors)

Jaw NeoplasmsSkull NeoplasmsBone NeoplasmsNeoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal DiseasesJaw DiseasesMaxillary DiseasesStomatognathic Diseases

Study Officials

  • hassan harby

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

hassan harby

CONTACT

0101261001harby1990hassan@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 17, 2020

First Posted

August 21, 2020

Study Start

September 25, 2020

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations

EG(1)