Clinical trial NCT06597604: Evaluation of the Effectiveness and Security of TenaTac® in the Prevention of Air Leaks in Thoracic Surgery
Official title: Evaluation of the Effectiveness and Security of TenaTac® in the Prevention of Air Leaks in Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lung Surgery
Keywords: Lung surgery
TenaTac
Gelatin Patch
Sealant
PAL
Pulmonary Air Leak
Lobectomy
Lead sponsor: Hopitaux Prives de Metz, Groupe UNEOS
Sponsor class: OTHER
Collaborators: name: CuraMedrix B.V.
name: Medical Advices Consulting
First posted: 2024-09-19
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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 (\&gt;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.

Primary outcomes:
measure: 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
timeFrame: 4 weeks
Secondary outcomes:
measure: 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).
timeFrame: 4 weeks
measure: Effectiveness of the TenaTac® patch in reducing hospital stay
timeFrame: 4 weeks
measure: Effectiveness of the TenaTac® patch in preventing (immediate and medium term) postoperative complications
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Metz
country: France
facility: Hôpital Robert Schuman_Groupe UNEOS
state: Grand-Est
city: Bayonne
country: France
facility: Centre Hospitalier de la Côte Basque (Bayonne)
Study officials:
affiliation: Hôpitaux Privés de Metz, Groupe UNEOS
name: Alessandro ORSINI, MD
role: PRINCIPAL_INVESTIGATOR
References: