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The long-term safety and multi-center post-marketing clinical research of using medical adhesive for wound closure during lung surgery

The long-term safety and multi-center post-marketing clinical research of using medical adhesive for wound closure during lung surgery

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087776
Enrollment
Unknown
Registered
2024-08-05
Start date
2024-08-12
Completion date
Unknown
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung disease

Interventions

Research group:Medical adhesive

Sponsors

Shanghai Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Individuals aged 18 years or older (including 18 years old), with no gender restrictions; 2) Patients who are scheduled to undergo elective lung resection surgery, such as lobectomy, segmentectomy, and/or wedge resection, following the normal medical consultation process, using open or minimally invasive surgery (VATS, da Vinci robot); 3) Patients who experience a grade 2 air leak when the lung inflation pressure is between 20-30 cm H2O, medical adhesive can be used; 4) Patients who are informed and voluntarily sign the "Informed Consent Form".

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1) BMI greater than 28 kg/m²; 2) History of previous thoracic surgery; 3)Intraoperative findings of extensive adhesions in the thoracic cavity (adhesions involving more than one lung lobe); 4) Intraoperative complications (major bleeding, organ damage, etc.); 5) Intraoperative performance of total lung resection, sleeve resection, extended lobectomy, and other similar procedures; 6) Intraoperative or postoperative bronchial leakage; 7) Patients received dialysis treatment; 8) Patients with hypoxemia, pulmonary insufficiency; 9) Patients received neoadjuvant therapy; 10) Patients participated in other clinical trials within one month.

Design outcomes

Primary

MeasureTime frame
Patient-oriented composite endpoints;

Secondary

MeasureTime frame
Incidence of all-cause mortality (within 6 months);Incidence of pneumothorax (within 6 months);Duration of postoperative air leak (within 6 months);Residual pleural effusion/air (within 6 months);Incidence of atelectasis (within 6 months);Incidence of acute respiratory distress syndrome (ARDS) (within 6 months);Incidence of pulmonary collapse (within 6 months);Incidence of renal insufficiency (within 6 months);Incidence of cardiac adverse events requiring intervention (atrial or ventricular arrhythmias, myocardial infarction) (within 6 months);Incidence of readmission/intervention related to pulmonary surgery (within 6 months);Incidence of thoracic infection (within 6 months);Incidence of other adverse events (within 6 months);

Countries

China

Contacts

Public ContactWentao Fang

Department of thoracic surgery, Shanghai Chest Hospital

vwtfang@hotmail.com+86 139 0186 7516

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026