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Evaluation of the Effectiveness and Security of TenaTac® in the Prevention of Air Leaks in Thoracic Surgery
Sponsor: Hopitaux Prives de Metz, Groupe UNEOS
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
154
Start Date
2025-03-01
Completion Date
2026-06-30
Last Updated
2025-02-03
Healthy Volunteers
No
Conditions
Interventions
Intraoperative use of TenaTac in lung surgery
Use of innovative medical device : TenaTac
Intraoperative use of usual sealant in lung surgery
Use of the usual scealant as a control
Locations (2)
Hôpital Robert Schuman_Groupe UNEOS
Metz, Grand Est, France
Centre Hospitalier de la Côte Basque (Bayonne)
Bayonne, France