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

A Phase II Prospective, Single Blinded, Randomized Trial of Hemopatch Compared to Standard Techniques to Achieve Air Leak Control After Complex Thoracic Surgical Procedures on High Risk Population for Prolonged Air Leak (> 5 Days - PAL).

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Thoracic Surgery Lung; Post-operative Thoracic Air Leak
• Intervention / Treatment: Device: Hemopatch; Device: standard techniques used to achieve air leak control

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy
    • Istituto Nazionale Tumori - Fondazione "G.Pascale", IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: standard treatment; standard techniques to achieve air leak control after complex thoracic surgical procedures	Device: standard techniques used to achieve air leak control
Experimental: standard treatment plus hemopatch; the addition of hemopatch to standard techniques to achieve air leak control after complex thoracic surgical procedures	Device: Hemopatch; Other Names: sealing hemostat; Device: standard techniques used to achieve air leak control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of days from time of extubation to time of drainage tube removal	up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of days to end of air leak	air leak measure are recorded every 6 hours	up to 7 days
worst grade toxicity per patient	according to Common Terminology Criteria for Adverse Events version 4.0	up to 6 weeks
change in quality of life		baseline, one week, one month
number of days from surgical intervention to patient discharge		up to 2 weeks

Collaborators and Investigators

• Sponsor: National Cancer Institute, Naples
• Collaborators: Baxter Healthcare Corporation; Fondazione IRCCS Istituto Nazionale dei Tumori, Milano; Istituto Clinico Humanitas; European Institute of Oncology; Regina Elena Cancer Institute
• Investigators: Principal Investigator: Gaetano Rocco, MD, FRCSEd, National Cancer Institute, Naples

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: February 10, 2015
• First Posted (Estimate): February 18, 2015

Study Record Updates

• Last Update Posted (Actual): March 24, 2023
• Last Update Submitted That Met QC Criteria: March 23, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: pulmonary resection; chest tube; segmentectomy; lobectomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: Hemopatch

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