Phase 3
N=260
Effectiveness Novel Tissue Sealant, Prevention Prolonged Air Leak (PAL) After Lung Resection
Prolonged Air Leak · Lung Resection
Bottom Line
View on ClinicalTrials.gov: NCT02491671 ↗Enrolled (actual)
260
Serious AEs
4.2%
Results posted
Jul 2021
Primary outcome: Primary: Number of Participants With Prolonged Air Leak (PAL) — 33; 24 Participants — p=0.171
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Hemopatch (Device); standard preventive measures (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Prolonged Air Leak (PAL) |
33; 24 | 0.171 |
| SECONDARY Duration of Air Leaks |
1; 1 | >0.05 |
| SECONDARY Number of Participants With at Least One Chest Tube Reinsertion |
3; 6 | 0 .307 sig |
| SECONDARY Number of Participants With One or More Readmission |
0; 0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02491671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.