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NOT YET RECRUITING
NCT06597604
NA

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

Sponsor: Hopitaux Prives de Metz, Groupe UNEOS

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

154

Start Date

2025-03-01

Completion Date

2026-06-30

Last Updated

2025-02-03

Healthy Volunteers

No

Conditions

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

Locations (2)

Hôpital Robert Schuman_Groupe UNEOS

Metz, Grand Est, France

Centre Hospitalier de la Côte Basque (Bayonne)

Bayonne, France