The safety and efficacy of Fibrin sealant Thai Red Cross Society compared with commercially Fibrin sealant in post-operative air leakage

Phase II/III to evaluate the safety and efficacy of Thai Red Cross Society fibrin sealant compared with commercially available fibrin sealant (TISSEEL) in post-operative air leak. A randomized controlled trial

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20240924011

Enrollment

Registered

2024-09-24

Start date

2025-01-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Lobectomy patients or segmentectomy/wedge resection patients with post-operative air leakage from lung tissue post-operative air leakage, Fibrin Sealant, lobectomy, segmentectomy, wedge resection

Interventions

IP name : Fibrin sealant TRCS Drug substance : 1. Sealer protein solution: Human fibrinogen 60 mg/ML 2. Thrombin solution: Human thrombin 500 IU/ML Pharmaceutical form : Solution Appearance: Colo

Experimental Drug,Active Comparator Drug

fibrin sealant from Thai Red Cross Society ,Tisseel

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patient age more than or equal to 18 years old 2.Patients requiring lobectomy or segmentectomy/wedge resection surgery, who have postoperative air leakage from lung tissue during surgery. 3.Patients providing consent to participate in the research and surgery

Exclusion criteria

Exclusion criteria: 1.Patients undergoing bilateral lung surgery 2.Patients requiring repeated surgery 3.Patients with status of HIV infection, hepatitis B or C infection and Syphilis infection

Design outcomes

Primary

Measure	Time frame
intercostal drainage hours after operation Duration of intercostal drainage	—

Secondary

Measure	Time frame
satisfaction score Operation day Physician satisfaction score,healthcare expenditure completion of study Total healthcare expenditure,hospital stay Post-operation Duration of hospital stay,factors influencing post-operative air leakage Post-operation evaluation of factors influencing post-operative air leakage,infection and post-operative bleeding Post-operation Incidence of infection and postoperative bleeding,prolonged air-leak requiring reoperation completion of study Number of patients with prolonged air-leak requiring reoperation,Adverse events Post-operation within 2 months Adverse events report	—

Measure

Time frame

satisfaction score Operation day Physician satisfaction score,healthcare expenditure completion of study Total healthcare expenditure,hospital stay Post-operation Duration of hospital stay,factors influencing post-operative air leakage Post-operation evaluation of factors influencing post-operative air leakage,infection and post-operative bleeding Post-operation Incidence of infection and postoperative bleeding,prolonged air-leak requiring reoperation completion of study Number of patients with prolonged air-leak requiring reoperation,Adverse events Post-operation within 2 months Adverse events report

—

Countries

Thailand

Contacts

Public ContactKittanun Wongsriyanon

Faculty of Medicine, Chulalongkorn University

kittanun11@gmail.com0860323457

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026