Lung sealant and morbidity after pleural decortication: a prospective randomized, blinded study

Area of Science:

• Thoracic surgery
• Pulmonary medicine
• Medical device innovation

Background:

• Prolonged postoperative air leaks (AL) are a significant source of morbidity following thoracic procedures.
• Empyema thoracis, a serious infection of the pleural space, often requires surgical intervention like pleural decortication.
• Managing air leaks effectively is crucial for patient recovery and reducing hospital stay.

Purpose of the Study:

• To evaluate the efficacy of the Pleuraseal Lung Sealant System in reducing air leaks after pleural decortications for empyema thoracis.
• To compare outcomes between patients treated with the lung sealant and a control group receiving standard care.

Main Methods:

• A prospective study involving 46 patients undergoing pleural decortication for empyema (excluding post-procedural and malignancy-related cases).
• Patients were randomized into a Control group or a Sealant group where Pleuraseal was applied to air leak sites.
• Key outcome measures included the incidence of AL, duration of chest drainage, hospital stay, C-reactive protein (CRP), and leukocyte counts, with blinded assessment.

Main Results:

• The Sealant group demonstrated a significantly lower incidence of persistent air leaks (30% vs. 78%, p = 0.012) compared to the Control group.
• Chest drains were removed significantly earlier in the Sealant group (median 3 days vs. 5 days, p = 0.05).
• While the Sealant group had a shorter hospital stay, the difference was not statistically significant (p = 0.121). No adverse effects or increased infectious markers (CRP, leukocytes) were observed.

Conclusions:

• The Pleuraseal Lung Sealant System effectively reduces air leaks following pleural decortications for empyema.
• The sealant is safe for routine use, even in procedures involving contaminated pleural spaces, as evidenced by stable infectious indexes.
• This innovation offers a promising solution for managing air leaks, potentially improving patient outcomes and resource utilization.