Evaluation of the Effectiveness and Security of TenaTac® in the Prevention of Air Leaks in Thoracic Surgery (TENATAC)

Hopitaux Prives de Metz, Groupe UNEOS

Status: Not yet enrolling

Conditions: Lung Surgery

Treatments: Device: Intraoperative use of usual sealant in lung surgery; Device: Intraoperative use of TenaTac in lung surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT06597604

2024-A01716-41 (Other Identifier)

PI-2024-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 154 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 registered within the social security insurance in France.

Exclusion criteria

• 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,
• Patients unable to follow the planned post-operative follow-up,
• Patients whose life expectancy is less than 1 year,
• Pregnant or breast-feeding patients.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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154 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Thoracic Surgeons will apply the experimental device TenaTac® after major lung resection

Treatment:

Device: Intraoperative use of TenaTac in lung surgery

Control Group

Active Comparator group

Description:

Thoracic Surgeons will apply other (usual) sealing device after major lung resection

Treatment:

Device: Intraoperative use of usual sealant in lung surgery