Role of Leukocyte- and Platelet-Rich Fibrin Membranes in Endoscopic Endonasal Skull Base Reconstruction

Role of Leukocyte- and Platelet-Rich Fibrin Membranes in Endoscopic Endonasal Skull Base Reconstruction

Prospective investigation of the effectivity of L-PRF membranes for skull base reconstruction after endoscopic endonasal skull base surgery (transsphenoidal) versus classical closure techniques.

The investigators want to demonstrate in a prospective, randomized trial including 220 patients undergoing endoscopic endonasal skull base surgery that the use of L-PRF is non-inferior to classical fibrin sealants.

Approximately 220 patients undergoing cranial surgery will be enrolled in this randomized, controlled, single-blinded multicenter study to evaluate the safety and effectiveness of autologous blood-derived products (L-PRF and fibrinogen) compared to the fibrin sealants as an adjunct for dural repair.

Inclusion Criteria:

• Patients with lesions of the sellar/parasellar region
• Age > 18 and < 70 years
• Written informed consent
• Willingness to adhere to visit schedules

Exclusion Criteria:

• Age < 18 and > 70 years
• Any underlying rhinological condition like nasal polyps, which may interfere with the obtained results
• Any disorder which might compromise the ability of a patient to give truly informed consent for participation in this study
• Enrollment in other investigational drug trial(s)