Effectiveness Novel Tissue Sealant, Prevention Prolonged Air Leak (PAL) After Lung Resection

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Status and phase: Completed; Phase 3

Conditions: Prolonged Air Leak; Lung Resection

Treatments: Device: Hemopatch; Procedure: standard preventive measures

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02491671

HEMOPATCH/FAP/2014

Details and patient eligibility

About

The effectiveness of tissue sealants to prevent Prolonged Air Leak (PAL) after lung resection procedures remains unproved. The investigators hypothesize that one of the main reasons for that is the heterogeneity of previously studied populations. Since currently the risk of postoperative PAL can be scored with a reasonable accuracy, the aim of this research is to investigate the effect of routine application of a novel tissue sealant in patients selected on the basis of a high risk of PAL estimated before surgery.

Enrollment: 260 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled anatomical lung resection indicated for any non-infectious disease (excluding Pneumonectomy)
• Patients classified in class D according estimated risk of PAL
• Age between 18 and 80 years

Exclusion criteria

• Those patients that according to Investigator assessment are not going to tolerate the procedure
• Clinical and anesthetic criteria that contraindicate surgery
• Severe uncontrolled illness
• Pregnancy
• Patients that are under Investigational New Drug treatment or have participated in study with a investigational drug (authorized or not) in 30 days before randomization.
• Lack of Informed Consent or patient refusal
• Postsurgery mechanical ventilation or repeated surgery in follow-up month.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

Experimental group

Experimental group

Description:

Experimental group: At the end of lung resection, lung sutures and 1.5 cm of lung parenchyma on each side will be covered by Hemopatch. No additional measures for preventing air leak will be indicated. In the case of massive air leak in spite of the use of Hemopatch, each surgeon will decide on the indication of additional sutures of tissue plasties. These cases will be accounted for failures on an intention to treat basis.

Treatment:

Procedure: standard preventive measures

Device: Hemopatch

Control group

Other group

Description:

Control group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat

Treatment:

Procedure: standard preventive measures