Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06255483 |
| Other study ID # |
Teaching Hospital Maamouri |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2004 |
| Est. completion date |
January 24, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
Mohamed Tahar Maamouri University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
