Managing air leaks during lung surgery with a new hydrogel
Intra-operative Air Leak Management After Minimally Invasive Lung Segmental Resection: Randomized Comparison Between Polymeric Hydrogel Matrix and Standard of Care
This study is testing if a new hydrogel can help reduce air leaks during lung surgery for patients having minimally invasive procedures.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Padova Academic / other |
| Locations | 1 site (Padua) |
| Trial ID | NCT06544200 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a polymeric hydrogel matrix in managing intraoperative alveolar air leaks during minimally invasive lung segmental resections. Patients undergoing video-assisted thoracoscopic surgery (VATS) will be assessed for moderate air leaks and randomized to receive either the hydrogel treatment or standard care. The primary goal is to determine if the hydrogel can reduce the incidence of postoperative air leaks, while secondary outcomes include the duration of chest drains and hospital stays. The study aims to address a common complication in lung surgeries that can lead to increased healthcare costs and patient risks.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 undergoing anatomical pulmonary segmentectomy via VATS or RATS for either benign or malignant lung disease.
Not a fit: Patients who are under 18, pregnant, or have chronic kidney failure, as well as those undergoing different types of pulmonary resections or open surgeries, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce complications and healthcare costs associated with air leaks after lung surgery.
How similar studies have performed: While the management of air leaks in lung surgery is a known challenge, the use of polymeric hydrogel matrices is a novel approach that has not been extensively tested in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients aged \> 18 years * undergoing anatomical pulmonary resection (segmentectomy) via VATS or RATS * benign and/or malignant lung disease * No known allergy to any of the components of the device Exclusion Criteria: * Refusal or inability to give informed consent to the study protocol * Age \< 18 years * Pregnancy * Chronic Kidney Failure * Allergies or contraindications to any of the Polymeric Hydrogel Matrix components * Patients undergoing pulmonary resections different than segmentectomy (wedge, lobectomy, bilobectomy, pneumonectomy) * Patients undergoing open surgery * More than one chest tube after lung resection
Where this trial is running
Padua
- Thoracic Surgery Unit — Padua, Italy (Recruiting)
Study contacts
- Principal investigator: Samuele Nicotra, MDF — Thoracic Surgery Unit, University Hospital of Padua
- Study coordinator: Samuele Nicotra, MD
- Email: samuele.nicotra@aopd.veneto.it
- Phone: +390498212242
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.