L-PRF in Cranial Surgery

Cranial Sutures; Closure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03812120
• Other study ID #: s61460
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2019
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Tom Theys, Prof
• Phone: 003216344290
• Email: tom.theys[@]uzleuven.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cranial Sutures; Closure

Intervention

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
• Dural closure with classical fibrin sealants
Evaluation of the safety and effectiveness of classical fibrin sealants as an adjunct for dural repair

Locations

Country	Name	City	State
Belgium	Tom Theys	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate	The success rate is considered a thigh closure of the dura in both groups, which means no CSF leakage. This success rate was estimated at 95% in both techniques.	4 years
Secondary	Cost effectiveness evaluation	A carefull registration of the used products (L-PRF versus commercial fibrin sealants), the quantity and the actual costs of these products will be noted during the operation procedure and will be analyzed.	4 years
Secondary	Complications	Analysis of perioperative and postoperative complications, in particular surgical-site infection, treatment-site bleeding and CSF leakage.	4 years