Clinical trial · Interventional
NoSeal Trial: Comparing Sealants Versus No Sealant for Preventing CSF Leak After Endonasal Skull Base Surgery
The NoSeal Trial - Nasal Outcome Study Evaluating Artificial Leak-Sealing: A Prospective, Randomized, Controlled, Single-Blinded, Single-Center Clinical Trial Comparing Fibrin Glue (Tisseel®) and a Two-Component Synthetic Polymer Sealant (PEI/PEG, Adherus®) Versus No Sealant for the Prevention of Cerebrospinal Fluid Leak and Promotion of Wound Healing Following Endonasal Skull Base Surgery, Designed in Accordance With the SPIRIT 2025 Guidelines
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Postoperative cerebrospinal fluid (CSF) leak is a significant complication of endoscopic endonasal approaches (EEA) to the skull base. The use of tissue sealants such as fibrin glue (Tisseel) or synthetic agents (PEI/PEG) is widespread in surgical practice, however, recent high-quality evidence challenges their clinical benefit and cost-effectiveness. This study aims to investigate whether the routine use of sealants in patient with peri-operatively assessed low CSF leak risk, significantly improves outcomes over no sealant use, to guide more cost- effective, evidence-based closure strategies. To the best of our knowledge, the present study is the first randomized clinical trial to evaluate the necessity and comparative effectiveness of fibrin and synthetic sealants versus no sealant in preventing postoperative CSF leaks following endoscopic endonasal surgery in low-post operative CSF leak risk patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| CerebroSpinal Fluid (CSF) Leak | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fibrin sealant application | Device | — | UNRESOLVED |
| Standard multilayer closure without sealant | Procedure | — | UNRESOLVED |
| Synthetic polyethylene glycol-based sealant | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- No Sealant - Standard Multilayer Closure
- description
- Patients in this arm will receive standard multilayer closure without the use of any sealant. Closure will involve mucosal flap repositioning and hemostatic agents (e.g., Surgicel®, TachoSil®), in accordance with standard endoscopic skull base reconstruction techniques.
- interventionNames
- Procedure: Standard multilayer closure without sealant
- type
- EXPERIMENTAL
- label
- Fibrin Glue - Tisseel® Application
- description
- Patients will undergo standard multilayer closure followed by application of fibrin sealant (Tisseel®). This arm evaluates the effect of biologic tissue glue in preventing postoperative CSF leaks and promoting wound healing following endonasal skull base surgery.
- interventionNames
- Device: Fibrin sealant application
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Scheduled for endoscopic endonasal surgery involving standard skull base reconstruction * Informed written consent obtained prior to enrollment * Hemodynamic and electrolyte stability before surgery * Procedure expected to be completed without use of high-flow intraoperative CSF diversion techniques Exclusion Criteria: * Revision surgery or extended endoscopic approaches requiring complex reconstruction (e.g., clival or cribriform defects) * Tumors requiring complex sella reconstruction from the start * Preoperative hydrocephalus * Known allergy to fibrin-based or synthetic sealant components * Active sinus infection or systemic inflammatory disease * Prior radiotherapy to the sellar or parasellar region * Uncontrolled diabetes mellitus (HbA1c \> 7.0%) * Participation in another interventional trial that may influence wound healing or CSF assessment * Radiologic signs of chronic intracranial hypertension or hypotension
References
Publications (0)
Data not yet available