Cranial Sutures; ClosureNCT03910374
Role of Leukocyte- and Platelet-Rich Fibrin Membranes in Endoscopic Endonasal Skull Base Reconstruction
A study testing Dural closure in people with Cranial Sutures; Closure, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in 2 countries.
Trial summary
Prospective investigation of the effectivity of L-PRF membranes for skull base reconstruction after endoscopic endonasal skull base surgery (transsphenoidal) versus classical closure techniques. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cranial Sutures; Closure
- What is being tested?
- Dural closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Nov 2018to 28 Dec 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with lesions of the sellar/parasellar region
- Age > 18 and < 70 years
- Written informed consent
- Willingness to adhere to visit schedules
Who cannot join
- Age < 18 and > 70 years
- Any underlying rhinological condition like nasal polyps, which may interfere with the obtained results
- Any disorder which might compromise the ability of a patient to give truly informed consent for participation in this study
- Enrollment in other investigational drug trial(s)
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Prospective investigation of the effectivity of L-PRF membranes for skull base reconstruction after endoscopic endonasal skull base surgery (transsphenoidal) versus classical closure techniques.
Read the detailed description
The investigators want to demonstrate in a prospective, randomized trial including 220 patients undergoing endoscopic endonasal skull base surgery that the use of L-PRF is non-inferior to classical fibrin sealants.
Approximately 220 patients undergoing cranial surgery will be enrolled in this randomized, controlled, single-blinded multicenter 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.
- Conditions
- Cranial Sutures; Closure
- Being tested
- Dural closure
- Keywords
- L-PRF, fibrin sealants, endoscopic endonasal skull base reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dural closureProcedure or surgery
Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF and fibrinogen) compared to the fibrin sealants as an adjunct for dural repair
| Study group | Role | What they receive |
|---|---|---|
| Classical Treatment | Placebo comparator | In this arm, dural closure will be performed with the classical fibrine sealants. Receives: Procedure: Dural closure |
| L-PRF | Active comparator | In this arm, dural closure will be performed with the autologous L-PRF Receives: Procedure: Dural closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the prevalence of CSF-leaks after L-PRF closure and after the classical closure techniques for sellar defects to demonstrate non-inferiority
The primary aim of this study is identifying the role of L-PRF in the endoscopic endonasal closure of skull base defects. More specific, we want to demonstrate in a prospective, randomized trial that the use of L-PRF is non-inferior to classical closure techniques regarding prevalence of CSF-leaks The number of patients with a CSF-leak will be compared between both treatment groups.
Measured: 4 years
Cost-effectiveness evaluation based on the effectiveness and the costs of L-PRF versus the current golden standard (Tachosil and Tisseel).
Cost-effectiveness evaluation: compare the costs and the effectiveness of L-PRF versus commercial fibrin sealants.
Measured: 4 years
Secondary outcomes (8)
To identify potential risk for closure-failures based on the size of the lesion
The potential risk for closure-failure (evaluated by the prevalence of CSF-leaks) based size of lesion ( evaluated by Wilson-Hardy classification) will be measured.
Measured: 4 years
To evaluate if the pathology is a potential risk factor for closure-failures
The potential risk for closure-failure (evaluated by the prevalence of CSF-leaks) based on the pathology will be evaluated.
Measured: 4 years
To evaluate if the age of the patient is a potential risk factor for closure-failures
The potential risk for closure-failure (evaluated by the prevalence of CSF-leaks) based on the age of the patients will be measured.
Measured: 4 years
Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on a visual analogue scale
Rhinological symptoms as well as quality of life before and after surgery will be assessed using a visual analogue scale. The symptoms will be scored on a horizontal line of 10 cm, where 0 cm equals "no symptoms" and 10 cm equals "very severe symptoms".
Measured: 4 years
Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the SNOT-22
Rhinological symptoms as well as quality of life before and after surgery will be assessed using a SNOT-22. The symptoms will be scored between 0 and 5 where 0 equals "no symptoms" and 5 equals "very severe symptoms".
Measured: 4 years
Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the skull base questionnaire
Rhinological symptoms as well as quality of life before and after surgery will be assessed using the skull base questionnaire.
Measured: 4 years
Evaluate the effect of L-PRF versus the current golden standard (Tachosil and Tisseel) on post-operative symptoms based on the EQ-5D
Rhinological symptoms as well as quality of life before and after surgery will be assessed using the EQ-5D
Measured: 4 years
Evaluate the potential interference of the L-PRF membranes with post-operative imaging by comparing the tumor residue evaluation 3 months and 1 year after surgery
potential interference of the L-PRF membranes with post-operative imaging (MRI) will be evaluated. 3 months after surgery, when the L-PRF membrane is still visible, the MRI images will be evaluated to see if there is tumor residue present or not. After 1 year the presence of tumor residue will be reevaluated. The outcomes will be compared between both evaluation timepoints to asses if L-PRF has interference with the imaging.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start1 Nov 2018
- Primary completion1 Oct 2025
- Study completion28 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cranial Sutures; ClosureStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Van Gerven, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Laura Van Gerven, prof, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910374
- Sponsor's protocol ID
- s61636
- Status last verified
- Apr 2026
- First submitted
- 20 Mar 2019
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Coucke B, Van Hoylandt A, Jorissen M, Meulemans J, Decramer T, van Loon J, Vander Poorten V, Theys T, Van Gerven L. Leukocyte- and platelet-rich fibrin in endoscopic endonasal skull base reconstruction: study protocol for a multicenter prospective, parallel-group, single-blinded randomized controlled non-inferiority trial. Trials. 2023 Jul 31;24(1):488. doi: 10.1186/s13063-023-07492-w.
PubMed 37525278