Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06597604
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Evaluation of the Effectiveness and Security of TenaTac in the Prevention of Air Leaks in Thoracic Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Effectiveness and Security of TenaTac in the Prevention of Air Leaks in Thoracic Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TENATAC
Brief Summary:
Lung surgery remains a high-risk procedure with serious adverse events that can occur later including postoperative bleeding or hemothorax pneumopathy or surgical site infection but also per- and post-operative air leaks Majority the air leaks resolve spontaneously within 48 hours but certain cases persist within several days which known as prolonged air leaks or PAL Several safe and effective sealing agents are used to contain and or reduce the intensity and incidence of postoperative air leaks and the time required for drain removal This protocol assesses the effectiveness of an innovative gelatin-based medical device named TenaTac Selentus Science UK in preventing air leak after major lung resection
Detailed Description:
Thoracic surgery is a specialty dedicated to the management diagnosis and treatment of conditions and lesions of the thoracic cage and its organs excluding the heart aorta and esophagus It is based on 2 surgical techniques open by posterolateral thoracotomy or minimally invasive endoscopic with or without robot-assisted surgery
Lobectomy is the most common pulmonary resection however regardless of the surgical option chosen lung surgery remains a high-risk procedure with serious adverse events that can occur later including postoperative bleeding or hemothorax pneumopathy or surgical site infection pulmonary alveolar collapse acute respiratory distress syndrome pleural or pericardial effusion lobar torsion or multi-organ failure bronchial or esophageal fistulas transient arrhythmia due to vagus nerve damage pulmonary embolism venous ischemia and per- and post-operative air leaks Air leak has been reported in 25-75 of patients which makes it the most common incident after elective lung surgery
Although the majority of these air leaks resolve spontaneously within 48 hours by continuous pleural drainage certain cases persist for several days more than 5 days These are known as prolonged air leaks or PAL
The literature describes several sealing agents used to contain air leaks The preventive use of sealants at the lung resection site seems safe and effective since it significantly reduces the intensity and incidence of postoperative air leaks and the time required for drain removal Pharmaceutical gelatin-based medical devices used for decades for their hemostatic properties have recently been suggested for sealing pulmonary defects and preventing air leaks Regarding the results obtained gelatin appears to be a therapeutically effective biomaterial in lung surgery We therefore hypothesize the effectiveness of the innovative medical device TenaTac Selentus Science UK in preventing air leak after major lung resection
Lobectomy is the most common pulmonary resection however regardless of the surgical option chosen lung surgery remains a high-risk procedure with serious adverse events that can occur later including postoperative bleeding or hemothorax pneumopathy or surgical site infection pulmonary alveolar collapse acute respiratory distress syndrome pleural or pericardial effusion lobar torsion or multi-organ failure bronchial or esophageal fistulas transient arrhythmia due to vagus nerve damage pulmonary embolism venous ischemia and per- and post-operative air leaks Air leak has been reported in 25-75 of patients which makes it the most common incident after elective lung surgery
Although the majority of these air leaks resolve spontaneously within 48 hours by continuous pleural drainage certain cases persist for several days more than 5 days These are known as prolonged air leaks or PAL
The literature describes several sealing agents used to contain air leaks The preventive use of sealants at the lung resection site seems safe and effective since it significantly reduces the intensity and incidence of postoperative air leaks and the time required for drain removal Pharmaceutical gelatin-based medical devices used for decades for their hemostatic properties have recently been suggested for sealing pulmonary defects and preventing air leaks Regarding the results obtained gelatin appears to be a therapeutically effective biomaterial in lung surgery We therefore hypothesize the effectiveness of the innovative medical device TenaTac Selentus Science UK in preventing air leak after major lung resection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None