Cranial Sutures; Closure
Conditions
Keywords
L-PRF, CSF leakage, fibrin sealants
Brief 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.
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).
Interventions
PROCEDUREDural closure with classical fibrin sealants
Evaluation of the safety and effectiveness of classical fibrin sealants as an adjunct for dural repair
PROCEDUREDural closure with L-PRF
Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF) as an adjunct for dural repair
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participants stay masked during the trial, care provider and investigators are unblinded at the surgical procedure and from thereon.
Intervention model description
randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost effectiveness evaluation | 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. |
| Complications | 4 years | Analysis of perioperative and postoperative complications, in particular surgical-site infection, treatment-site bleeding and CSF leakage. |
Countries
Belgium
Contacts
Primary ContactTom Theys, Prof
Backup ContactAnais Van Hoylandt, Sc
Outcome results
None listed