225
Participants
Start Date
August 15, 2025
Primary Completion Date
December 30, 2026
Study Completion Date
March 15, 2027
Standard multilayer closure without sealant
Patients will undergo standard skull base reconstruction using mucosal flap repositioning and absorbable hemostatics (e.g., Surgicel®, TachoSil®), without application of any fibrin or synthetic sealant. This serves as the control group for comparison with sealant-assisted closures.
Fibrin sealant application
Following standard multilayer closure, patients in this group will receive topical application of a fibrin-based biological sealant (Tisseel®). The intervention aims to assess its effectiveness in preventing postoperative cerebrospinal fluid (CSF) leak and promoting mucosal healing after endoscopic endonasal skull base surgery.
Synthetic polyethylene glycol-based sealant
After standard multilayer closure, a synthetic two-component sealant (Adherus®, composed of polyethylene glycol and polyethylenimine) will be applied to reinforce the reconstruction site. This group is used to evaluate the efficacy and safety of synthetic sealant in preventing CSF leaks and supporting wound healing.
RECRUITING
Maria Sklodowska-Curie Institute - Oncology Center, Warsaw
Maria Sklodowska-Curie National Research Institute of Oncology
OTHER