NoSeal Trial: Comparing Sealants Versus No Sealant for Preventing CSF Leak After Endonasal Skull Base Surgery

NARecruitingINTERVENTIONAL
Enrollment

225

Participants

Timeline

Start Date

August 15, 2025

Primary Completion Date

December 30, 2026

Study Completion Date

March 15, 2027

Conditions
CerebroSpinal Fluid (CSF) Leak
Interventions
PROCEDURE

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.

DEVICE

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.

DEVICE

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.

Trial Locations (1)

Unknown

RECRUITING

Maria Sklodowska-Curie Institute - Oncology Center, Warsaw

All Listed Sponsors
lead

Maria Sklodowska-Curie National Research Institute of Oncology

OTHER

NCT07216157 - NoSeal Trial: Comparing Sealants Versus No Sealant for Preventing CSF Leak After Endonasal Skull Base Surgery | Biotech Hunter | Biotech Hunter