NCT06771336

Biomedical Innovation for Facial Bone Reconstruction in Oncology: BIOFACE PASS a Medico-economic Study Describing the Standard Pathway of Patients Treated by Free Bone Flap

Standard of Care Pathways Evaluation of Patients Treated for Facial Reconstruction After Surgery for Head and Neck Cancer, Using the Conventional Technique (Free Bone Flap): a Medico-economic Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to describe the standard of care pathway of patients treated by free bone flap for facial mandibullar or maxillar reconstruction after surgery for head and neck cancers.

Detailed description

Curative management of head and neck cancers frequently requires an interrupting mandibulectomy or maxillectomy. Surgery may involve resection of anatomical structures such as jaw or maxilla. The use of free vascularized fibula or scapula flap is the "gold standard" for mandibular and maxillary reconstruction but remains suboptimal as resulting in difficulty in speaking, swallowing, and disfigurement. The BIOFACE project, funded by "Appel à Projet -Recherche Hospitalo-Universitaire en santé (RHU)" number 6 France 2023, aims to develop a new biomaterials based device to reconstruct these structure after surgery. In addition to the clinical benefits, this project aims to demonstrate the medico-economic benefits of the BIOFACE solution. Therefore, the Bioface PASS study has been designed to describe standard of care pathways of patients treated by free bone flap for facial reconstruction after surgery for head and neck cancer. Direct medical and non-medical costs, and daily allowance 12 months after the end of treatment, and quality of life will be recorded at the inclusion, 3 and 12 months. From the hospital perspectives, production costs will be recorded using the micro-costing approach.

Conditions

• Head and Neck Cancers

Interventions

Type	Name	Description
OTHER	Questionnaires	Quality of life questionnaires, questionnaires for assessing functional results, micro-costing questionnaire, informal support assessment questionnaires

Timeline

• Start date: 2025-09-03
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2025-01-13
• Last updated: 2025-09-22

Locations

9 sites across 1 country: France