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

Phase 3

Completed

• Conditions: Prolonged Air Leak; Lung Resection

• Registration Number: NCT02491671
• Lead Sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-06-10
• Study First Submitted QC: 2015-07-03
• Study First Posted: 2015-07-08
• Study Start: 2015-11-24
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Results First Submitted: 2021-04-15
• Results First Submitted QC: 2021-07-05
• Results First Posted: 2021-07-27
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-06
• Last Update Posted: 2021-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Participants With Prolonged Air Leak (PAL)	From day of surgery to the fifth postoperative day	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

Secondary Outcome Measures

Name	Time	Method
Duration of Air Leaks	Check everyday from day of surgery up to 38 days post-operative at maximum	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)
Number of Participants With at Least One Chest Tube Reinsertion	From day of surgery up to 30 days thereafter	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.
Number of Participants With One or More Readmission	30 days post-operative	Rate of readmissions due to relapsing pneumothorax (follow-up 30 days)

Trial Locations

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; 🇪🇸 Sevilla, Spain