L-PRF in Cranial Surgery

Universitaire Ziekenhuizen KU Leuven

Status: Unknown

Conditions: Cranial Sutures; Closure

Treatments: Procedure: Dural closure with L-PRF; Procedure: Dural closure with classical fibrin sealants

Study type: Interventional

Funder types: Other

Identifiers

NCT03812120

s61460

Details and patient eligibility

About

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.

Full 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).

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing cranial neurosurgery whereby the dura is intentionally opened (supratentorial and infratentorial approach)
• Age ≥ 18 years
• Written informed consent
• Willing to comply with the study schedule

Exclusion criteria

• Participation in another clinical trial with study drugs or devices
• Pregnancy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

350 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 with classical fibrin sealants

L-PRF

Active Comparator group

Description:

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

Treatment:

Procedure: Dural closure with L-PRF