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Intra-operative Air Leak Management After Minimally Invasive Lung Segmental Resection

NCT06544200 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2025-07-31

No results posted yet for this study

Summary

In patients undergoing minimally invasive thoracoscopic surgery (video-assisted thoracoscopic surgery, or VATS), a still unsolved issue is represented by intraoperative alveolar air leaks (IOAALs), which if prolonged beyond the fifth postoperative day can lead to higher risk of complications and higher medical costs. The polymeric hydrogel matrix (PHM) is a novel tool to manage intraoperative IOAALs. The primary end-point of our study was to verify whether PHM would be able to reduce postoperative air leaks; secondary end-points were the possible reduction of the permanence time of the chest drain (CD) and the hospital length (HL) in the PHM group compared with no treatment.

Conditions

  • Lung Cancer Stage I
  • Lung; Node
  • Air Leak From Lung

Interventions

DEVICE

Polymeric Hydrogel Matrix

application of Polymeric Hydrogel Matrix along the suture line at the completion of lung resection

Sponsors & Collaborators

  • University Hospital Padova

    lead OTHER

Principal Investigators

  • Samuele Nicotra, MDF · Thoracic Surgery Unit, University Hospital of Padua

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-15
Primary Completion
2024-07-13
Completion
2024-07-13

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06544200 on ClinicalTrials.gov