SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial Using HEMOPATCH

Prospective Randomized Clinical Trial to Prevent Air Leaks After Lung Resection With Hemopatch™ Sealing Hemostat: SEALLS (Sealing Evaluation of Air Leaks After Lung Surgery) Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02668978

Enrollment

170

Registered

2016-01-29

Start date

2016-03-31

Completion date

2019-08-31

Last updated

2019-09-04

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

Conditions

LUNG DISEASES

Keywords

lung surgery, air leak, prevention

Brief summary

The primary objective is to assess the efficacy and safety of HEMOPATCH™ Sealing Hemostat in reducing the incidence and duration of air leaks after lung resection compared to standard techniques. Hypothesis: The routine application of HEMOPATCH Sealing Hemostat on the visceral pleura in lung resection areas, during lung resection procedures, is more EFFICIENT to reduce the incidence and duration of prolonged air leaks as compared to standard surgical measures.

Interventions

DEVICEHemopatch™ Sealing Hemostat

Hemopatch™ application over lung resection areas

PROCEDUREStandard surgical technique

Lung resuturing or restapling

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients over the age of 18 years who are able to give their informed consent * Patients undergoing lung resection surgery for either malignant or benign conditions including: * Lobar and sublobar resections * Open, video-assisted thoracoscopic or robotic surgeries * Diagnostic or therapeutic procedures

Exclusion criteria

* Traumatic pulmonary contusion or laceration * Lung reduction surgery * Planned removal of more than 10 lung lesions * Pneumonectomy * Known hypersensitivity to bovine protein * Known hypersensitivity to Brilliant Blue FCF (E133) * Presence of active infection

Design outcomes

Primary

Measure	Time frame	Description
Duration of postoperative air leaks	Within first 30 postoperative days	Duration of postoperative lung air leaks expressed in hours

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026