- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03812120
L-PRF in Cranial Surgery
L-PRF in Cranial Surgery: a Prospective, Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Tom Theys, Prof
- Phone Number: 003216344290 003216344290
- Email: tom.theys@uzleuven.be
Study Contact Backup
- Name: Anais Van Hoylandt, Sc
- Phone Number: 003216342012 003216342012
- Email: anais.vanhoylands@uzleuven.be
Study Locations
-
-
-
Leuven, Belgium, 3000
- Recruiting
- Tom Theys
-
Contact:
- Tom Theys, Prof
- Phone Number: 003216344290 003216344290
- Email: tom.theys@uzleuven.be
-
Contact:
- Anais Van Hoylandt
- Phone Number: 003216342012 003216342012
- Email: anais.vanhoylandt@uzleuven.be
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Classical Treatment
In this arm, dural closure will be performed with the classical fibrine sealants.
|
Evaluation of the safety and effectiveness of classical fibrin sealants as an adjunct for dural repair
|
Active Comparator: L-PRF
In this arm, dural closure will be performed with the autologous L-PRF
|
Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF) as an adjunct for dural repair
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success rate
Time Frame: 4 years
|
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
Time Frame: 4 years
|
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
Time Frame: 4 years
|
Analysis of perioperative and postoperative complications, in particular surgical-site infection, treatment-site bleeding and CSF leakage.
|
4 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tom Theys, Prof, UZ Leuven
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- s61460
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cranial Sutures; Closure
-
Universitaire Ziekenhuizen KU LeuvenRecruitingCranial Sutures; ClosureBelgium, Spain
-
Aesculap AGB.Braun Surgical SACompletedPediatric and Adult: Mucosal Closure in Facial and Oral Surgery | Pediatric and Adult: Skin Closure (Dermal Sutures) | Women: Episiotomy | Pediatric: Urological Interventions (Circumcision, Phimosis Etc.)Germany
-
Queen's UniversityCompletedEducation, Medical | SuturesCanada
-
Johannes Gutenberg University MainzCompletedEducation | Clinical Skills | Sutures | Intra-osseousGermany
-
Instituto de Olhos de GoianiaCentro de Referência em OftalmologiaCompletedEfficacy of a Technique (Brassiere Sutures)
-
Universidade do Vale do SapucaiCompletedCesarean Section | SuturesBrazil
-
Ethicon, Inc.Completed
-
Ladera MedicalAvaniaNot yet recruitingVascular Closure | Femoral Arteriotomy Closure
-
National University Hospital, SingaporeCompletedChronic Angle Closure Glaucoma | Primary Angle Closure | Primary Angle Closure Suspect | Fellow Eyes of Acute Angle Closure GlaucomaSingapore
-
Shanghai Ninth People's Hospital Affiliated to...Not yet recruitingDental Implants | Wound Healing | Sutures
Clinical Trials on Dural closure with classical fibrin sealants
-
Centro Cardiologico MonzinoCompletedPatent Foramen Ovale | Migraine With Aura | Platelet Aggregation, SpontaneousItaly
-
Shanghai Tong Ren HospitalRecruitingAcute Coronary Syndrome Patients With Diabetes After PCIChina
-
Samsung Medical CenterTerminatedCoronary Artery Disease | Atherosclerosis | StentsKorea, Republic of
-
Duke UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruitingHeart Failure | Pain | Pneumonia | Hypertension | Edema | Hemophilia | Insomnia | Pulmonary Arterial Hypertension | Coagulation Disorder | Asthma in Children | Down Syndrome | Attention Deficit Hyperactivity Disorder | Bronchopulmonary Dysplasia | Hypokalemia | Hyperphosphatemia | Primary Hyperaldosteronism | Adrenal Insufficiency and other conditionsUnited States, Canada