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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Surgery
• Intervention / Treatment: Device: Intraoperative use of TenaTac in lung surgery; Device: Intraoperative use of usual sealant in lung surgery

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.

• Study Type: Interventional
• Enrollment (Estimated): 154
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sofiane Saada, PhD; Phone Number: +33 +33357843376; Email: sofiane.saada@uneos.fr
• Study Contact Backup: Name: Alessandro ORSINI, MD; Phone Number: +33 +33357842227; Email: alessandro.orsini@uneos.fr

Study Locations

• France
  • Bayonne, France, 64100
    • Centre Hospitalier de la Côte Basque (Bayonne)
    • Contact: Caroline RIVERA, MD; Phone Number: +33 +33559443502; Email: crivera@ch-cotebasque.fr
    • Contact: Caroline RIVERA, MD
  • Grand-Est
    • Metz, Grand-Est, France, 57000
      • Hôpital Robert Schuman_Groupe UNEOS
      • Contact: Sofiane Saada, PhD; Phone Number: +33 +33357843376; Email: sofiane.saada@uneos.fr
      • Contact: Alessandro ORSINI, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Thoracic Surgeons will apply the experimental device TenaTac® after major lung resection	Device: Intraoperative use of TenaTac in lung surgery; Use of innovative medical device : TenaTac
Active Comparator: Control Group; Thoracic Surgeons will apply other (usual) sealing device after major lung resection	Device: Intraoperative use of usual sealant in lung surgery; Use of the usual scealant as a control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 weeks
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	4 weeks
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	4 weeks

Collaborators and Investigators

• Sponsor: Hopitaux Prives de Metz, Groupe UNEOS
• Collaborators: CuraMedrix B.V.; Medical Advices Consulting
• Investigators: Principal Investigator: Alessandro ORSINI, MD, Hôpitaux Privés de Metz, Groupe UNEOS

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 12, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 30, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Lung surgery; Lobectomy; PAL; Sealant; TenaTac; Gelatin Patch; Pulmonary Air Leak
• Other Study ID Numbers: PI-2024-002; 2024-A01716-41 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data collected throughout the trial used in the results publication will be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No