CompletedPhase 4

SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial Using HEMOPATCH

Spain170 participantsStarted 2016-03

Plain-language summary

The primary objective is to assess the efficacy and safety of HEMOPATCH™ Sealing Hemostat in reducing the incidence and duration of air leaks after lung resection compared to standard techniques. Hypothesis: "The routine application of HEMOPATCH Sealing Hemostat on the visceral pleura in lung resection areas, during lung resection procedures, is more EFFICIENT to reduce the incidence and duration of prolonged air leaks as compared to standard surgical measures."

Who can participate

Age range18 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: * Patients over the age of 18 years who are able to give their informed consent * Patients undergoing lung resection surgery for either malignant or benign conditions including: * Lobar and sublobar resections * Open, video-assisted thoracoscopic or robotic surgeries * Diagnostic or therapeutic procedures Exclusion Criteria: * Traumatic pulmonary contusion or laceration * Lung reduction surgery * Planned removal of more than 10 lung lesions * Pneumonectomy * Known hypersensitivity to bovine protein * Known hypersensitivity to Brilliant Blue FCF (E133) * Presence of active infection

What they're measuring

Duration of postoperative air leaks

Timeframe: Within first 30 postoperative days

Trial details

NCT IDNCT02668978

SponsorQuirón Madrid University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-08-31

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