A Phase II Prospective, Single Blinded, Randomized Trial of Hemopatch Compared to Standard Techniques to Achieve Air Leak Control After Complex Thoracic Surgical Procedures

NCT ID: NCT02364791

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2024-12-31

Brief Summary

The purpose of this study is to explore whether the addition of Hemopatch to standard care can reduce prolonged air leaks and shorten the use of air drainage tube after surgery in thoracic lung surgery patients at high risk for prolonged air leaks.

Conditions

Thoracic Surgery Lung; Post-operative Thoracic Air Leak

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

standard treatment

standard techniques to achieve air leak control after complex thoracic surgical procedures

Group Type: ACTIVE_COMPARATOR

standard techniques used to achieve air leak control

Intervention Type: DEVICE

standard treatment plus hemopatch

the addition of hemopatch to standard techniques to achieve air leak control after complex thoracic surgical procedures

Group Type: EXPERIMENTAL

standard techniques used to achieve air leak control

Intervention Type: DEVICE

Hemopatch

Intervention Type: DEVICE

Interventions

standard techniques used to achieve air leak control

Intervention Type: DEVICE

Hemopatch

Intervention Type: DEVICE

Other Intervention Names

sealing hemostat

Eligibility Criteria

Inclusion Criteria

• Age ≥18 years
• High risk of prolonged air leak due to at least one of the following reasons:

• Preoperative FEV1<80%
• DLco < 80%
• LVRS (lung volume reduction surgery o pneumoplastica riduttiva)
• Anticipation of intraoperative adhesions (ie, redo surgery)
• Previous induction chemotherapy for locally advanced NSCLC
• Chronic steroid use
• Pleural mesothelioma
• Candidate to one of the following major thoracic surgical intervention:

• Decortication
• Reintervention on the same side of the previous intervention
• Segmentectomy
• Lobectomy with incomplete fissures on CT scan
• Written informed consent.

Exclusion Criteria

• Pregnancy or breast-feeding
• Evidence of confusion or disorientation, or history of major psychiatric illness that may impair the patient's understanding of the Informed Consent Form or their ability to comply with study requirements
• Any unstable systemic disease (including active infections, any significant hepatic, renal or cardiovascular disease), metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates or prevents or the execution of surgery
• Known hypersensitivity to bovine proteins or brilliant blue (FD&C Blue No.1)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

OTHER

Sponsor Role: collaborator

Istituto Clinico Humanitas

OTHER

Sponsor Role: collaborator

European Institute of Oncology

OTHER

Sponsor Role: collaborator

Regina Elena Cancer Institute

OTHER

Sponsor Role: collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

National Cancer Institute, Naples

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gaetano Rocco, MD, FRCSEd

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute, Naples

Francesco Perrone, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute, Naples

Locations

Istituto Nazionale Tumori - Fondazione "G.Pascale", IRCCS

Napoli, , Italy

Countries

Italy

Other Identifiers

Hemopatch

Identifier Type: -

Identifier Source: org_study_id