CompletedPhase 3

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

Spain260 participantsStarted 2015-11-24

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of Participants With Prolonged Air Leak (PAL)

Timeframe: From day of surgery to the fifth postoperative day

Trial details

NCT IDNCT02491671

SponsorFundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06-30

Results submitted2021-04-15