Evaluation of the Effectiveness and Security of TenaTac® in the Prevention of Air Leaks in Thoracic Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intraoperative use of TenaTac in lung surgery, Intraoperative use of usual sealant in lung surgery.
- Who it may be relevant to
- Registry conditions: Lung Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Intraoperative use of TenaTac in lung surgery
Use of innovative medical device : TenaTac - Device Intraoperative use of usual sealant in lung surgery
Use of the usual scealant as a control
Primary outcome measures
- 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 [Time frame: 4 weeks]
Secondary outcome measures (3)
- 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). [Time frame: 4 weeks]
- Effectiveness of the TenaTac® patch in reducing hospital stay [Time frame: 4 weeks]
- Effectiveness of the TenaTac® patch in preventing (immediate and medium term) postoperative complications [Time frame: 4 weeks]
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 (\>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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
France · 2 centers
- Hôpital Robert Schuman_Groupe UNEOS — Metz
- Centre Hospitalier de la Côte Basque (Bayonne) — Bayonne
Identifiers
NCT: NCT06597604 · PI-2024-002 · 2024-A01716-41