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

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León260 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

260

Conditions

Prolonged Air Leak Lung Resection

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (6)

Hospital Universitario Marqués de Valdecilla de Santander

Santander, Cantabria, Spain

Hospital Clinic

Barcelona, Spain

Hospital Universitario Ramón y Cajal de Madrid

Madrid, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital Universitario de Salamanca (CAUSA)

Salamanca, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

Outcomes

Primary Outcomes

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

Time frame: From day of surgery to the fifth postoperative day

Secondary Outcomes

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)

Time frame: 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.

Time frame: 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)

Time frame: 30 days post-operative