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OpenTrials
Completed

NCT Number: NCT02668978

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

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."

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Key information

Conditions

Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Quirónsalud Madrid University Hospital

Pozuelo de Alarcón, Madrid, 280222, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hemopatch™ Sealing Hemostat

Device

Hemopatch™ application over lung resection areas

Standard surgical technique

Procedure

Lung resuturing or restapling

Primary outcomes

  1. Duration of postoperative air leaks

    Time frame: Within first 30 postoperative days

    Duration of postoperative lung air leaks expressed in hours

Sponsors and collaborators

Lead sponsor

Quirón Madrid University Hospital

Other

Collaborators

  • Baxter BioScience

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 29, 2016
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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