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.
Patients hospitalized in the thoracic surgery departments of the investigating centers, for elective surgery,
Lobectomy surgery requiring the use of a sealing agent,
Adult patients (>18 years),
Patients who have given written consent to participate in the study,
Patients hospitalized in emergency,
Patients with gelatin allergy,
Patients undergoing other biomedical research likely to interfere with the evaluation criteria of this study
Patients under tutorship and/or curatorship,
Hopitaux Prives de Metz, Groupe UNEOS
Lead sponsor
CuraMedrix B.V.
Collaborator
Medical Advices Consulting
Collaborator