Viewing Study NCT06255483



Ignite Creation Date: 2024-05-06 @ 8:05 PM
Last Modification Date: 2024-10-26 @ 3:20 PM
Study NCT ID: NCT06255483
Status: COMPLETED
Last Update Posted: 2024-02-13
First Post: 2024-02-04

Brief Title: Anatomical Research of the Clavicular Pedicled Flap for Mandibular Reconstruction
Sponsor: Mohamed Tahar Maamouri University Hospital
Organization: Mohamed Tahar Maamouri University Hospital

Study Overview

Official Title: Anatomical Research of the Clavicular Pedicled Flap for Mandibular Reconstruction Vascularization and Harvesting Technique
Status: COMPLETED
Status Verified Date: 2024-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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
Detailed Description: An osteoperiosteal clavicular flap was harvested from the right side on 10 fresh male cadaver specimens whose age of death ranged between 42 and 65 years The dissection was carried out by the investigator at the laboratory of the Anatomy of René Descartes University of Medicine in Paris in 2004 as well as in the Forensic Medicine Department of Mohamed Tahar Maamouri University Hospital in Tunisia

Technical steps for harvesting the pedicled osteoperiosteal clavicular flap

The cadaver is placed in dorsal recumbency and a pad under the shoulders A cervical incision with a Z shape was performed in which the upper branch was placed two centimeters below and parallel to the inferior jawline to preserve the marginal mandibular nerve The vertical branch of the incision continued following the path of the sternocleidomastoid muscle and reached the lower branch of the Z at the level of the clavicle

The dissection was carried out in the cervical regions sub-platysmal plane and the pre-pectoral and pre-deltoid planes The deep plane can be approached through an incision of the superficial cervical fascia overlying the sternocleidomastoid muscle taking into consideration the spinal accessory nerve Then the clavicle was released from the sternocleidomastoid muscle but the subclavius muscle insertion was preserved on the clavicle to protect the subclavian vein branches The level of undermining dissection was confined to the loose fat pad overlaying the scalene muscle within which the vessels are embedded without exposing the brachial plexus

The anterior surface of the subclavian vein was exposed and the vessels arising from this vein were ligated The clavicular bone attached to a celluloadipous pedicle has been lifted exposing the thyrocervical trunk A celluloadipous tissue around the branches of this trunk cervical transverse artery inferior thyroid artery ascending cervical artery and suprascapular artery was preserved in their dissection and care was taken to avoid injury of the phrenic nerve noticeable near the inferior thyroid artery Then the cervical transverse and suprascapular arteries were ligated at their distal part Nevertheless the inferior thyroid artery could be also ligated which increases the total pedicle length of the flap and improves its arc of rotation Otherwise the flap will be bi-pedicled The ascending cervical artery was dissected along the anterior scalene muscle up to the level of the transverse process of the fourth cervical vertebrae which is considered the vascular pedicle rotation point

The vascular supply of the clavicular flap was highlighted by injecting the thyrocervical trunk with coloured latex after ligating the following arteries at their distal parts the inferior thyroid the suprascapular and the cervical transverse

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None