Cranial Sutures; Closure Clinical Trial
Official title:
L-PRF in Cranial Surgery: a Prospective, Randomized Trial
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.
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).
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03910374 -
Role of Leukocyte- and Platelet-Rich Fibrin Membranes in Endoscopic Endonasal Skull Base Reconstruction
|
N/A |