Trials / Completed
CompletedNCT02491671
Effectiveness Novel Tissue Sealant, Prevention Prolonged Air Leak (PAL) After Lung Resection
Prospective, Multicenter, Open-Label, Randomized, Phase III Clinical Trial of Prevention of Prolonged Air Leak After Lung Resection in High-risk Patients, Applying HEMOPATCH®
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 260 (actual)
- Sponsor
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Hemopatch | |
| PROCEDURE | standard preventive measures |
Timeline
- Start date
- 2015-11-24
- Primary completion
- 2019-06-30
- Completion
- 2019-06-30
- First posted
- 2015-07-08
- Last updated
- 2021-08-09
- Results posted
- 2021-07-27
Locations
6 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT02491671. Inclusion in this directory is not an endorsement.