Anatomical Research of the Clavicular Pedicled Flap for Mandibular Reconstruction

NCT06255483 | Completed

• 1 other identifier: Teaching Hospital Maamouri
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Because of the proximity of the clavicular bone to the oral cavity, and the suitable characteristics of the bone for implant placement, its use as a pedicled flap is an attractive method of mandibular reconstruction. This research, performed on fresh cadaver specimens, describes the vascular supply and harvesting technique of a pedicled clavicular bone allowing a mandibular reconstruction with a single surgical field.

Conditions

Mandibular Reconstruction; Maxillofacial Injuries

Keywords

Clavicle; Pedicled Flap; Bosniak Node; Microvascular Network; Mandibular reconstruction

Outcome Measures

Primary Outcomes (3)

• Vasculature of the flap

  Clavicular periosteal vessels emerging from the cervical transverse artery were highlighted and further identified after methylene blue injection

  Immediately after harvesting the flap

• Facial accessibility

  Mandibular and zygomatic region were reached by this flap

  Immediately after harvesting the flap

• Bone characteristics

  full-thickness bone with a length ranging between 9 and 11 centimeters.

  Immediately after harvesting the flap

Study Arms (1)

Osteoperiosteal clavicular flap

OTHER

Harvesting of a pedicled osteoperiosteal clavicular flap and clarification of its vascular supply

Other: Osteoperiosteal pedicled clavicular flap for mandibular and facial bone reconstruction

Interventions

Osteoperiosteal pedicled clavicular flap for mandibular and facial bone reconstruction OTHER

A clavicular flap with a vascular supply based on the transverse cervical artery which receives a reverse blood supply from the ascending cervical artery. This vascular pattern is reliable because of the existence of the sub-occipital microvascular network named the " Bosniak node ".

Also known as: Anatomical Research of the clavicular pedicled flap for mandibular reconstruction

Osteoperiosteal clavicular flap

Eligibility Criteria

• Age: 42 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fresh cadaveric speciemen

You may not qualify if:

• Neck injury or previous neck dissection

Sponsors & Collaborators

• Mohamed Tahar Maamouri University Hospital: lead

Study Sites (1)

University Hospital Mohamed Tahar Maamouri

Nabeul, 8000, Tunisia

Location

MeSH Terms

Conditions

Maxillofacial Injuries

Interventions

Mandibular Reconstruction

Condition Hierarchy (Ancestors)

Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Orthognathic Surgical Procedures; Oral Surgical Procedures; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: The harvest of a pedicle osteoperiosteal clavicular flap was performed in the same way on ten fresh cadaveric specimens. The vascular supply was studied by colored latex and methylene blue injections.

Study Record Dates

• First Submitted: February 4, 2024
• First Posted: February 13, 2024
• Study Start: March 1, 2004
• Primary Completion: October 7, 2022
• Study Completion: January 24, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Anatomical research of the clavicular pedicled flap for mandibular reconstruction: vascularization and harvesting technique

Locations

TU (1)