LUNG DISEASES Clinical Trial
Official title:
Prospective Randomized Clinical Trial to Prevent Air Leaks After Lung Resection With Hemopatch™ Sealing Hemostat: SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial
NCT number | NCT02668978 |
Other study ID # | SEALLS |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | August 31, 2019 |
Verified date | August 2019 |
Source | Quirón Madrid University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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."
Status | Completed |
Enrollment | 170 |
Est. completion date | August 31, 2019 |
Est. primary completion date | August 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Spain | Quirónsalud Madrid University Hospital | Pozuelo de Alarcón | Madrid |
Lead Sponsor | Collaborator |
---|---|
Quirón Madrid University Hospital | Baxter BioScience |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of postoperative air leaks | Duration of postoperative lung air leaks expressed in hours | Within first 30 postoperative days |
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