Clinical trial NCT06714760: Evaluation of the Galea-pericranium Flap in Reconstruction of Oral Cavity Defects
Official title: Evaluation of the Galea-pericranium Flap in Reconstruction of Oral Cavity Defects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Disease
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The overall objective of this study is to evaluate the safety of using the galea and pericranium (fascio-periosteal) temporal flap in the reconstruction of mandibular gingival defects.

Detailed description: Reconstruction with free flaps is a routine practice in head and neck surgery because of better functional, aesthetic results and generally higher success rates.

Current applications of this practice include reconstructive surgeries that follow excisions of neoplastic lesions involving the oral cavity. Following resection of the primary tumor, reconstructive surgery is usually necessary in order to restore function to the oral cavity.

The most appropriate reconstructive method is determined by several factors, including the characteristics of the defects and primary tumor site, the general medical condition, the patient's social history, the prognosis, and the surgeon's expertise. Reconstructive methods usually follow a "reconstructive ladder," starting with a skin graft and ending with a microvascular free flap.

Free tissue transfers are currently one of the most popular and reliable techniques for oral reconstruction.

The use of periosteal flaps for reconstruction of bone defects has been described by several authors. In particular, a well-known technique by Bettoni et al. \[5\] demonstrated excellent results, also in terms of bone regeneration, following the use of free periosteum flaps taken from radius in the treatment of osteoradionecrosis of mandible.

Free flaps of periosteum and osteoperiosteum of the medial femoral condyle have also been widely used for minimal bone reconstructions, such as those of the nasal bone, again with excellent results . However, harvesting these flaps is complex and the periosteum obtained is small in size.

Based on the assumption that the cranial region would provide surgeons with more options in terms of harvesting periosteum flaps to reconstruct soft and hard tissue defects, previous clinical experiences have explored the possibility of harvesting a galea and pericranium flap for reconstruction of oral mucosal defects resulting from excision of squamous cell carcinomas, obtaining positive results. Indeed, the temporal region is an important donor site in reconstructive surgery of the head and neck region, from which pedicled flaps of muscle, fascia, and skin can be harvested.

In particular, the vascular supply of the pericranial temporo-parietal region was evaluated in the above experience.

Previous clinical experience has demonstrated the efficacy of such a flap, used for the treatment of pharyngeal fistulas, as a revascularized free graft.

In conclusion, this type of flap has been shown to be functionally reliable for defects of the cervicofacial district, so we propose to apply it to parcellar defects of the oral cavity.

Eligibility criteria: Inclusion Criteria:

* Patients aged ≥18 years;
* Patients with mandibular gingival defects involving the anterior or lateral aspect of the mandible;
* Patients in whom basal structural integrity of the mandibular bone is maintained;
* Patients with a minimum follow-up of 3 months;
* Obtaining informed consent.

Exclusion Criteria:

• Patients with history of previous surgery that bilaterally altered the superficial temporal vasculature.

Primary outcomes:
measure: outcomes
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS - Azienda Ospedaliero Universitaria di Bologna
state: Emilia Romagna
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Achille Tarsitano, MD
role: PRINCIPAL_INVESTIGATOR
References: