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

Prospective, Multicenter, Open-Label, Randomized, Phase III Clinical Trial of Prevention of Prolonged Air Leak After Lung Resection in High-risk Patients, Applying HEMOPATCH®

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.

Study Overview

• Status: Completed
• Conditions: Prolonged Air Leak; Lung Resection
• Intervention / Treatment: Device: Hemopatch; Procedure: standard preventive measures

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic
  • Madrid, Spain, 28040
    • Hospital Clínico San Carlos
  • Madrid, Spain, 28034
    • Hospital Universitario Ramón y Cajal de Madrid
  • Salamanca, Spain, 37007
    • Hospital Universitario de Salamanca (CAUSA)
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio
  • Cantabria
    • Santander, Cantabria, Spain, 39008
      • Hospital Universitario Marqués de Valdecilla de Santander

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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.	Device: Hemopatch; Procedure: standard preventive measures
Other: Control group; Control group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat	Procedure: standard preventive measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Prolonged Air Leak (PAL)	Prevalence of Prolonged Air Leak (PAL) measured as binary variable (YES/NO) and recorded, from day of surgery to the fifth postoperative day, in the study questionnaire. The occurrence of the outcome will be recorded if air leak exists 5 days or more after surgery	From day of surgery to the fifth postoperative day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Air Leaks	Measured as continuous variable (days) and recorded, from day of surgery to the day of withdraw the chest tube. (standardized criteria for pulling out chest drainage/s will be agreed among investigators)	Check everyday from day of surgery up to 38 days post-operative at maximum
Number of Participants With at Least One Chest Tube Reinsertion	Rate of patients needing postoperative reinsertion of chest drainages due to symptomatic pneumothorax. Following daily during hospital stay and pone follow-up until 30th day post-operative.	From day of surgery up to 30 days thereafter
Number of Participants With One or More Readmission	Rate of readmissions due to relapsing pneumothorax (follow-up 30 days)	30 days post-operative

Collaborators and Investigators

• Sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
• Collaborators: Baxter Healthcare Corporation; Instituto de Investigación Biomédica de Salamanca
• Investigators: Study Director: Gonzalo Varela, MD PhD FETCS, IBSAL-Instituto de Investigación Biomédica de Salamanca

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2015
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: June 10, 2015
• First Submitted That Met QC Criteria: July 3, 2015
• First Posted (Estimate): July 8, 2015

Study Record Updates

• Last Update Posted (Actual): August 9, 2021
• Last Update Submitted That Met QC Criteria: August 6, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Prevention PAL Prolonged Air Leak (PAL); Lung Resection; Thoracic Surgery; Post-operative Thoracic Air Leak
• Other Study ID Numbers: HEMOPATCH/FAP/2014

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