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The effect of a new Pleural Drainage System in thoracic surgery

Evaluation of the effectiveness of the Sinapi Pleural Drainage System in thoracic surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-85qq6jc
Enrollment
Unknown
Registered
2023-06-22
Start date
2020-10-02
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Postoperative Complications

Interventions

This is a controlled prospective randomized clinical trial. 64 patients were included and one patient was excluded, totaling the analysis of 63 patients. Patients will be randomized into groups, accor
and the study group (V group)– using a flutter valve device, the Sinapi® Model XL1000® pleural collector employing a flutter valve (Biomedical, Stellenbosch, Idasvalle, África do Sul) (32 patients). T
E07.858

Sponsors

Instituto de Assistência Médica ao Servidor Público Estadual de São Paulo
Lead Sponsor
Instituto de Assistência Médica ao Servidor Público Estadual de São Paulo
Collaborator

Eligibility

Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Both genders; aged between 18 and 90 years; undergoing some type of partial lung resection

Exclusion criteria

Exclusion criteria: Pneumonectmy; joint wall resection; empyema on the same side of the surgery; VEF1 ppo (forced expiratory volume in one second predicted for the postoperative period) less than 40%

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: It is expected to find a decrease of 1 day in the time of interruption of air leak in the study group.;Expected outcome 2: It is expected to find a decrease of 1 day in the time for drain removal in the study group. ;Expected outcome 3: It is expected to find no complications with the tested system. ;Outcome found 3: There were no complications with the studied system; there was 1 complication with the standard system.;Outcome found 1: There was no statistically significant difference between the study group and the standard group.;Outcome found 2: There was no statistically significant difference between the study group and the standard group.

Secondary

MeasureTime frame
Secondary outcomes were not expected.

Countries

Brazil

Contacts

Public ContactRodrigo de Souza

Hospital do Servidor Público Estadual de São Paulo - Francisco Morato Oliveira

caetanorcs@gmail.com+55 11 99986-7524

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 7, 2026