Using Polyglycolic Acid Mesh Prevents Cerebrospinal Fluid Leakage

Last updated: June 24, 2024
Sponsor: National Taiwan University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pituitary Disorders

Treatment

polyglycolic acid(Neoveil)

Clinical Study ID

NCT06472505
202011030DIPB
  • Ages > 20
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: polyglycolic acid(Neoveil)
Phase:
Study Start date:
December 01, 2023
Estimated Completion Date:
December 31, 2025

Study 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 .

Connect with a study center

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Active - Recruiting

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