NCT03812120

L-PRF in Cranial Surgery

L-PRF in Cranial Surgery: a Prospective, Randomized Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators want to demonstrate in a prospective, randomized trial including 350 patients undergoing cranial surgery that the use of L-PRF is non-inferior to classical fibrin sealants.

Detailed description

The investigators want to demonstrate in a prospective, randomized trial including 350 patients undergoing cranial surgery that the use of L-PRF is non-inferior to classical fibrin sealants. Approximately 350 patients undergoing cranial surgery will be enrolled in this randomized, controlled, single-blinded monocenter 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 (= primary objective). The investigators will also evaluate if the use of L-PRF obviates the need for the use of other autologous grafts (e.g. muscle/fat), commercial collagen-based products (e.g. Tachosil) or articifial dura (=secondary objective).

Conditions

• Cranial Sutures; Closure

Interventions

Type	Name	Description
PROCEDURE	Dural closure with L-PRF	Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF) as an adjunct for dural repair
PROCEDURE	Dural closure with classical fibrin sealants	Evaluation of the safety and effectiveness of classical fibrin sealants as an adjunct for dural repair

Timeline

• Start date: 2018-12-01
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2019-01-22
• Last updated: 2019-01-22

Locations

1 site across 1 country: Belgium