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,
Parallel
Intraoperative use of TenaTac in lung surgery
DeviceUse of innovative medical device : TenaTac
Intraoperative use of usual sealant in lung surgery
DeviceUse of the usual scealant as a control
To compare the effectiveness of the TenaTac® patch on the duration of thoracic drainage for each patient (regardless of their degree of emphysema) compared to sealing devices routinely used by thoracic surgeons for the same indication
Assess the effectiveness of the TenaTac® patch in terms of duration of thoracic drainage, compared with sealing devices routinely used by thoracic surgeons for the same indication.
To assess the effectiveness of the TenaTac® patch in preventing postoperative air leaks throughout the hospital stay, and more specifically in PALs (beyond the 5th day).
Assess the effectiveness of the TenaTac® patch in terms of PAL rates decrease compared to those measured with the other sealants routinely used by thoracic surgeons for the same indication and in the same circumstances
Effectiveness of the TenaTac® patch in reducing hospital stay
Assess the effectiveness of the TenaTac® patch in reducing hospital stay, compared to those obtained with the other sealants routinely used by thoracic surgeons for the same indication and in the same circumstances
Effectiveness of the TenaTac® patch in preventing (immediate and medium term) postoperative complications
Assess the effectiveness of the TenaTac® patch in preventing (immediate and medium term) postoperative complications, compared to those declared with the other sealants routinely used by thoracic surgeons for the same indication and in the same circumstances
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Hopitaux Prives de Metz, Groupe UNEOS
Lead sponsor
CuraMedrix B.V.
Collaborator
Medical Advices Consulting
Collaborator
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