L-PRF in Cranial Surgery

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Cranial Sutures; Closure

Intervention / Treatment
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* Procedure: Dural closure with L-PRF
* Procedure: Dural closure with classical fibrin sealants


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Classical Treatment<br>In this arm, dural closure will be performed with the classical fibrine sealants. | Procedure: Dural closure with classical fibrin sealants<br>* Evaluation of the safety and effectiveness of classical fibrin sealants as an adjunct for dural repair<br>|
| Active Comparator: L-PRF<br>In this arm, dural closure will be performed with the autologous L-PRF | Procedure: Dural closure with L-PRF<br>* Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF) as an adjunct for dural repair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Complications | Analysis of perioperative and postoperative complications, in particular surgical-site infection, treatment-site bleeding and CSF leakage. | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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L-PRF, CSF leakage, fibrin sealants