For preventing air leak from surgical wounds during pulmonary surgery
Conditions
Interventions
Control group:Reinforcement of surgical wounds and prevention of air leak during open and thoracoscopic pulmonary surgery with the absorbable lung sealing medical bioadhesive
Trial Group:Reinforcement of surgical wounds and prevention of air leak during open and thoracoscopic pulmonary surgery with the absorbable lung sealing medical bioadhesive
Sponsors
Beijing Chaoyang Hospital Affiliated to Capitai Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: age 18-70 years (both 18 and 70 years) and is not restricted to gender; 2. patients who are proposed to undergo open and thoracoscopic pulmonary surgery; 3. patients who are able to choose the date for the appropriate pulmonary surgery in accordance with normal medical procedures; Patients are required to be able to understand the purpose of the trial, to participate voluntarily in this trial and sign the written informed consent, and to be able and willing to complete all examinations and follow-up visits.
Exclusion criteria
Exclusion criteria: patients with a history of ipsilateral pulmonary surgery within 3 months; 2. patients with a Body Mass Index (BMI) > 30 kg/m2; 3. patients with severe infection, or severe pleural adhesions; 4. patients with haemoglobin 10 mg/L; 8. patients who are scheduled to undergo chemotherapy within 1 month after surgery; 9. patients with comorbid hypoxemia, respiratory insufficiency, or concurrently requiring other procedures (e.g. endotracheal intubation, etc.) that that may affect the judgement of clinical outcome; 10. patients who are pregnant or breastfeeding, or who plan to be pregnant during the trial; 11. patients with known hypersensitivity to albumin, or patients with known allergy or hypersensitivity to ingredients in the test product or control product; 12. patients who have participated or are participating in the drug-related clinical trial within 3 months, or those who have participated or are participating in other medical device-related clinical trial within 30 days; Any other condition that, determined by the investigator, makes participation in the trial inadvisable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects without postoperative prolonged air leak (PAL); | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of chest drainage;Total drainage volume;Duration of postoperative air leak;Postoperative length of stay (LOS); | — |
Countries
China
Contacts
Public ContactBin Hu
Beijing Chaoyang Hospital Affiliated to Capitai Medical University
Outcome results
None listed