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

Lung Resection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02491671
• Other study ID #: HEMOPATCH/FAP/2014
• Status: Completed
• Phase: Phase 3
• Start date: November 24, 2015
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2021
• Source: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Resection
• Prolonged Air Leak

Intervention

Device:
• Hemopatch

Procedure:
• standard preventive measures

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital Universitario Ramón y Cajal de Madrid	Madrid
Spain	Hospital Universitario de Salamanca (CAUSA)	Salamanca
Spain	Hospital Universitario Marqués de Valdecilla de Santander	Santander	Cantabria
Spain	Hospital Universitario Virgen del Rocío	Sevilla

Sponsors (3)

Lead Sponsor	Collaborator
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León	Baxter Healthcare Corporation, Instituto de Investigación Biomédica de Salamanca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Number of Participants With One or More Readmission	Rate of readmissions due to relapsing pneumothorax (follow-up 30 days)	30 days post-operative