RecruitingNot ApplicableNCT07216157

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


Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Enrollment

225 participants

Start Date

Aug 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (the NoSeal Trial) is comparing two surgical techniques after minimally invasive brain surgery through the nose (called endonasal skull base surgery): using a tissue sealant to prevent cerebrospinal fluid (CSF) leaks versus not using one. This type of surgery is typically done to remove pituitary tumors or other skull base lesions. **You may be eligible if...** - You are 18 or older and are scheduled for endonasal (through-the-nose) skull base surgery with standard reconstruction - Your blood pressure and electrolytes are stable before surgery **You may NOT be eligible if...** - You are having revision (repeat) surgery or a complex reconstruction procedure - You have pre-existing hydrocephalus (fluid build-up in the brain) - You have a known allergy to the sealant materials - You have an active sinus infection or systemic inflammatory disease - You have had prior radiation to the pituitary/skull base area - Your blood sugar is poorly controlled (HbA1c above 7.0%) - You are participating in another trial that may affect healing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREStandard 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.

DEVICEFibrin 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.

DEVICESynthetic 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.


Locations(1)

Maria Sklodowska-Curie Institute - Oncology Center

Warsaw, Poland

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NCT07216157


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