Not yet recruitingNAINTERVENTIONAL

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

This study is investigating a new medical product called TenaTac. It's designed to be used during lung surgery to help prevent a common problem called air leaks. After lung surgery, some people experience air leaking from their lung, which can sometimes delay recovery. While many air leaks get better on their own, some can last longer. TenaTac is a special gel-based sealant that researchers believe could help reduce these air leaks, speed up recovery, and potentially mean drains can be removed sooner. This study compares TenaTac to other sealants typically used during lung operations to see if it’s more effective and safe for patients.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Hopitaux Prives de Metz, Groupe UNEOS

Enrolment target

154

Start

01 Mar 2025

Estimated completion

30 Jun 2026

Lung Surgery

What is this study about?

When someone has lung surgery, it's a significant operation, and like any surgery, there can be some problems afterwards. One of the most common issues is something called an 'air leak'. This happens when air escapes from the lung after it's been operated on. Most of the time, these air leaks heal up by themselves within a couple of days. However, sometimes they can last longer, which is known as a 'prolonged air leak', and this can mean staying in hospital for a longer time or needing a drain in the chest for longer.

Doctors already use special sealing products during lung surgery to help prevent or reduce these air leaks. These sealants are generally safe and help people recover better. This study is looking at a new, innovative product called TenaTac. It's a medical device made from a special kind of gel, similar to gelatin, which has been used safely in medicine for many years, for example, to help stop bleeding.

The main idea behind this study is to see if TenaTac is better than the usual sealants at preventing air leaks after major lung surgery, specifically an operation called a lobectomy, where a section of the lung is removed. Researchers want to find out if TenaTac can reduce the number and seriousness of air leaks, and potentially help patients get their chest drains out sooner and recover more quickly after surgery. The study will compare patients who receive TenaTac with those who receive the standard sealant.

Key takeaways

This study evaluates a new sealant called TenaTac for lung surgery.
It aims to prevent air leaks, a common issue after lung operations.
TenaTac is a gelatin-based product, similar to those safely used for years.
Participation involves receiving either TenaTac or a standard sealant during surgery.
The study assesses if TenaTac can lead to faster recovery and fewer complications.
Eligible participants are adults having planned lung removal surgery (lobectomy).

Who may be eligible?

To be part of this study, you would need to be an adult over 18 years old and already be planning to have scheduled lung surgery, specifically an operation called a lobectomy, at one of the hospitals taking part. You would also need to be someone who would usually receive a sealing product during this type of surgery.

There are certain reasons why you wouldn't be able to join the study. For example, if your surgery is an emergency rather than planned, or if you have an allergy to gelatin (the main ingredient in TenaTac). You also couldn't take part if you are involved in another medical study that might affect the results of this one, or if you are pregnant or breastfeeding.

Other reasons for not being able to join include if you have a life expectancy of less than a year, if you wouldn't be able to attend all the necessary follow-up appointments after surgery, or if you are under legal guardianship that prevents you from giving consent to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years of age or older?
Are you having planned lung surgery specifically to remove a lobe (lobectomy)?
Are you NOT pregnant or breastfeeding?
Do you NOT have an allergy to gelatin?
Are you NOT involved in any other medical research at this time?
Could you attend follow-up appointments after your surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new product, TenaTac, or the usual sealing product during your planned lung surgery. The doctors performing your operation would decide which one you receive, but you would be told if you were in the study. After your surgery, the medical team would carefully monitor you for any air leaks, just as they would with any patient having this type of operation.

Your participation would involve regular checks during your hospital stay and follow-up appointments after you go home. These appointments are designed to see how you are recovering, check for any air leaks, and monitor your general health. You would have your recovery tracked for a set period, which might involve physical examinations and possibly some questionnaires about how you are feeling. The exact total duration of your involvement, including all follow-up, would be fully explained to you before you agree to participate.

Potential risks and benefits

Whilst there are no guaranteed benefits for taking part, you might benefit if TenaTac proves to be more effective at preventing air leaks, potentially leading to a shorter hospital stay or a faster recovery than with standard treatment. The main risk identified is a possible allergic reaction to gelatin, which researchers generally screen for carefully. As with any medical study, there's always the chance that the new treatment might not be more effective than what's already available. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Hôpital Robert Schuman_Groupe UNEOS
Verified postcode
Metz, France
Centre Hospitalier de la Côte Basque (Bayonne)
Verified postcode
Bayonne, France

Common questions

What is an air leak?

An air leak happens when air escapes from the lung after surgery. It's quite common after lung operations.

What is TenaTac?

TenaTac is a new gel-based product that doctors would use during lung surgery to help seal the lung and prevent air leaks.

Is TenaTac safe?

Gelatin-based products like TenaTac have been used in medicine for many years. This study is looking at its safety and how well it works for preventing air leaks.

Will I know if I'm getting TenaTac or the usual sealant?

Yes, you would be fully informed about which treatment you receive as part of the study.

Can I leave the study if I change my mind?

Absolutely. You can withdraw from the study at any time without it affecting your medical care.

How to find out more

Sofiane Saada, PhD

sofiane.saada@uneos.fr +33357843376 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.