Ignite Creation Date:
2024-07-17 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06472505
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2022-06-20
Brief Title:
Using Polyglycolic Acid Mesh Prevents Cerebrospinal Fluid Leakage
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Using Polyglycolic Acid Mesh Prevents Cerebrospinal Fluid Leakage Clinical Application to Endoscopic Endonasal Transsphenoidal Surgery
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 surgeryetc 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None