Clinical trial NCT06255483: Anatomical Research of the Clavicular Pedicled Flap for Mandibular Reconstruction
Official title: Anatomical Research of the Clavicular Pedicled Flap for Mandibular Reconstruction: Vascularization and Harvesting Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mandibular Reconstruction
Maxillofacial Injuries
Keywords: Clavicle
Pedicled Flap
Bosniak Node
Microvascular Network
Mandibular reconstruction
Lead sponsor: Mohamed Tahar Maamouri University Hospital
Sponsor class: OTHER
First posted: 2024-02-13
Enrollment: 10
Sex: ALL
Minimum age (years): 42
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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 region's 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.

Eligibility criteria: Inclusion Criteria:

* Fresh cadaveric speciemen

Exclusion Criteria:

* Neck injury or previous neck dissection

Primary outcomes:
measure: Vasculature of the flap
timeFrame: Immediately after harvesting the flap
measure: Facial accessibility
timeFrame: Immediately after harvesting the flap
measure: Bone characteristics
timeFrame: Immediately after harvesting the flap
Secondary outcomes:
Other outcomes:
Locations:
city: Nabeul
country: Tunisia
facility: University Hospital Mohamed Tahar Maamouri
Study officials:
References: