Actively Recruiting
Evaluation of the Galea-pericranium Flap in Reconstruction of Oral Cavity Defects
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2024-12-04
5
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of using the galea and pericranium (fascio-periosteal) temporal flap for reconstructing mandibular gingival defects. This approach aims to improve function and appearance after surgical removal of oral cavity tumors. The study builds on previous experiences where similar flaps have been used successfully for head and neck reconstruction, including bone regeneration and treatment of pharyngeal fistulas. The study involves patients who need reconstruction following partial removal of the mandibular gingival region. Surgeons will use periosteum, galea, or pericranium flaps harvested from the cranial temporal region, which has good blood supply, to repair soft and hard tissue defects. This method is being assessed as a reliable option for oral cavity reconstruction after tumor excision. Participants will be followed for at least 18 months to monitor outcomes. Researchers will evaluate the function and safety of the flap reconstruction, including bone and tissue healing. Patients will have regular follow-up visits for assessments, and their progress will be closely monitored to measure the success of the surgical procedure and any related complications.
CONDITIONS
Brief Title
Evaluation of the Galea-pericranium Flap in Reconstruction of Oral Cavity Defects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 6518 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
You will not qualify if you...
- Patients with history of previous surgery that bilaterally altered the superficial temporal vasculature
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to hospital discharge or as determined by surgical recovery
Participants undergo reconstructive surgery using galea-pericranium flaps to repair oral cavity defects following tumor resection.
1 surgical visit and several immediate post-operative visits
Duration - At least 3 months
Participants receive follow-up care to monitor healing and functional outcomes of the oral cavity reconstruction.
Approximately 3 follow-up visits over 3 months
Trial Site Locations
Total: 1 location
1
IRCCS - Azienda Ospedaliero Universitaria di Bologna
Bologna, Emilia-Romagna, Italy, 40138
Actively Recruiting
Research Team
A
Achille Tarsitano, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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