Clinical trial NCT02491671: Effectiveness Novel Tissue Sealant, Prevention Prolonged Air Leak (PAL) After Lung Resection
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®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prolonged Air Leak
Lung Resection
Keywords: Prevention PAL Prolonged Air Leak (PAL)
Lung Resection
Thoracic Surgery
Post-operative Thoracic Air Leak
Lead sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación Biomédica de Salamanca
name: Baxter Healthcare Corporation
First posted: 2015-07-08
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Prolonged Air Leak (PAL)
timeFrame: From day of surgery to the fifth postoperative day
Secondary outcomes:
measure: Duration of Air Leaks
timeFrame: Check everyday from day of surgery up to 38 days post-operative at maximum
measure: Number of Participants With at Least One Chest Tube Reinsertion
timeFrame: From day of surgery up to 30 days thereafter
measure: Number of Participants With One or More Readmission
timeFrame: 30 days post-operative
Other outcomes:
Locations:
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla de Santander
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal de Madrid
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca (CAUSA)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
Study officials:
affiliation: IBSAL-Instituto de Investigación Biomédica de Salamanca
name: Gonzalo Varela, MD PhD FETCS
role: STUDY_DIRECTOR
References: