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

Universitaire Ziekenhuizen KU Leuven

Status: Unknown

Conditions: Cranial Sutures; Closure

Treatments: Procedure: Dural closure

Study type: Interventional

Funder types: Other

Identifiers

NCT03910374

s61636

Details and patient eligibility

About

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

Full description

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.

Enrollment: 220 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups, including a placebo group

Classical Treatment

Placebo Comparator group

Description:

In this arm, dural closure will be performed with the classical fibrine sealants.

Treatment:

Procedure: Dural closure

L-PRF

Active Comparator group

Description:

In this arm, dural closure will be performed with the autologous L-PRF

Treatment:

Procedure: Dural closure