CompletedNot Applicable

Role of Leukocyte- and Platelet-Rich Fibrin Membranes in Endoscopic Endonasal Skull Base Reconstruction

Belgium, Spain220 participantsStarted 2018-11-01

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients with lesions of the sellar/parasellar region * Age \> 18 and \< 70 years * Written informed consent * Willingness to adhere to visit schedules Exclusion Criteria: * 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)

What they're measuring

To compare the prevalence of CSF-leaks after L-PRF closure and after the classical closure techniques for sellar defects to demonstrate non-inferiority

Timeframe: 4 years

Cost-effectiveness evaluation based on the effectiveness and the costs of L-PRF versus the current golden standard (Tachosil and Tisseel).

Timeframe: 4 years

Trial details

NCT IDNCT03910374

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-01

View on ClinicalTrials.gov More Cranial Sutures; Closure trials