Using Polyglycolic Acid Mesh Prevents Cerebrospinal Fluid Leakage

Using Polyglycolic Acid Mesh Prevents Cerebrospinal Fluid Leakage: Clinical Application to Endoscopic Endonasal Transsphenoidal Surgery

The papers propose a new method to prevent postoperative cerebrospinal fluid leakage. Doctors use the absorbable polyglycolic acid (PGA) and fibrin glue to repair in surgery, prevent cerebrospinal fluid leakage and reduce the necessity of postoperative lumbar drainage after surgery. This study will analyze the changes in cerebrospinal fluid leakage in patients with pituitary tumors and skull base tumors after surgery, and further understand the effectiveness of Neoveil , as the basis for the development of new treatments.

Study Overview

• Status: Recruiting
• Conditions: Pituitary Tumor; Cerebrospinal Fluid Leakage
• Intervention / Treatment: Device: polyglycolic acid(Neoveil)

Detailed Description

Neoveil, the main component, is polyglycolic acid (PGA), which is a kind of absorbable material, and is made into a soft and tension non-woven material by special processing with good tissue compatibility and degradability. In the human body, its strength will gradually decrease due to hydrolysis, and will eventually be absorbed and metabolized. In the process of absorption, at first its strength is reduced, then the mass will gradually decrease, and it will be completely absorbed after about 15 weeks. At present, the United States, Europe, Australia, China and South Korea have been marketed, it is applied to the spine , pituitary tumors , skull base tumors and aneurysm surgery,etc. inthe related field of Neurosurgery in foreign countries. It can prevent the leakage of cerebrospinal fluid, and reduce the postoperative hospital stay and the probability of complications after surgery. There is a license from the TFDA. In clinical, it can be used in the sutures of parts or fragile organs that do not need to be healed for a long time, such as the lung, liver, and digestive tract, by suture (thick slice and tube type) or adhesion (Sheet) In the tissue, it can strengthen the compressive ability of the local tissue, prevent the suture thread from splitting the suture tissue, prevent the lung tissue from leaking, reduce the blood and fluid leakage from the surgical site, and reduce the postoperative hospital stay and after the operation The complication rate .

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abel Huang, MD; Phone Number: 265913 +8860223123456; Email: how.how0622@gmail.com
• Study Contact Backup: Name: Abel Huang, MD; Phone Number: 265913 +8860223123456

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Abel Huang, MD; Phone Number: 265913 +8860223123456; Email: how.how0622@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

A. Inclusion criteria

1. Patients with primary or recurrent pituitary tumors require endoscopic nasal surgery.

B. Exclusion criteria

1. Patients with pituitary gland tumors who do not receive surgical treatment.
2. Patients with other brain tumors.
3. Patients allergic to polyglycolic acid (PGA).
4. Patients who have had previous radiation therapy or chemotherapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Using polyglycolic acid mesh

Device: polyglycolic acid(Neoveil); This study plans to enroll patients with pituitary tumors who need to undergo surgical treatment according to current routine medical standards. After the tumor tissue is removed, the integrity of the spider web or skull base will be thoroughly checked by endoscopy during the operation to confirm whether there is any cerebrospinal fluid leakage. At the end of the operation, use a 100*50*0.15mm, green sheet-like Navi tissue repair patch, cut it aseptically to fit the size of the defect for repair (the common case is 2*3.5cm defect), and place it on the spider web or skull base Tissue repair at the surgical site to prevent cerebrospinal fluid leakage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mesurement CSF leakage grade change after surgery	Confirmation of change in CSF leakage grafe after surgery	6 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Abel Huang, MD, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 20, 2022
• First Submitted That Met QC Criteria: June 24, 2024
• First Posted (Actual): June 25, 2024

Study Record Updates

• Last Update Posted (Actual): June 25, 2024
• Last Update Submitted That Met QC Criteria: June 24, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Pituitary tumor; CSF leakage; Endoscopic transnasal transsphenoidal
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Neurologic Manifestations; Wounds and Injuries; Endocrine System Diseases; Endocrine Gland Neoplasms; Craniocerebral Trauma; Trauma, Nervous System; Hypothalamic Diseases; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Pituitary Neoplasms; Pituitary Diseases; Cerebrospinal Fluid Leak
• Other Study ID Numbers: 202011030DIPB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No