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OpenTrials
Completed

NCT Number: NCT02491671

Effectiveness Novel Tissue Sealant, Prevention Prolonged Air Leak (PAL) After Lung Resection

The effectiveness of tissue sealants to prevent Prolonged Air Leak (PAL) after lung resection procedures remains unproved. The investigators hypothesize that one of the main reasons for that is the heterogeneity of previously studied populations. Since currently the risk of postoperative PAL can be scored with a reasonable accuracy, the aim of this research is to investigate the effect of routine application of a novel tissue sealant in patients selected on the basis of a high risk of PAL estimated before surgery.

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Key information

Conditions

Prolonged Air Leak Lung Resection

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario Marqués de Valdecilla de Santander, Santander, Cantabria, Spain

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Scheduled anatomical lung resection indicated for any non-infectious disease (excluding Pneumonectomy)
  • Patients classified in class D according estimated risk of PAL
  • Age between 18 and 80 years

Exclusion criteria

  • Those patients that according to Investigator assessment are not going to tolerate the procedure
  • Clinical and anesthetic criteria that contraindicate surgery
  • Severe uncontrolled illness
  • Pregnancy
  • Patients that are under Investigational New Drug treatment or have participated in study with a investigational drug (authorized or not) in 30 days before randomization.
  • Lack of Informed Consent or patient refusal
  • Postsurgery mechanical ventilation or repeated surgery in follow-up month.

Treatment and study plan

HEMOPATCH

Device

standard preventive measures

Procedure

Primary outcomes

  1. Number of Participants With Prolonged Air Leak (PAL)

    Time frame: From day of surgery to the fifth postoperative day

    Prevalence of Prolonged Air Leak (PAL) measured as binary variable (YES/NO) and recorded, from day of surgery to the fifth postoperative day, in the study questionnaire. The occurrence of the outcome will be recorded if air leak exists 5 days or more after surgery

Secondary outcomes

  1. Duration of Air Leaks

    Time frame: Check everyday from day of surgery up to 38 days post-operative at maximum

    Measured as continuous variable (days) and recorded, from day of surgery to the day of withdraw the chest tube. (standardized criteria for pulling out chest drainage/s will be agreed among investigators)

  2. Number of Participants With at Least One Chest Tube Reinsertion

    Time frame: From day of surgery up to 30 days thereafter

    Rate of patients needing postoperative reinsertion of chest drainages due to symptomatic pneumothorax. Following daily during hospital stay and pone follow-up until 30th day post-operative.

  3. Number of Participants With One or More Readmission

    Time frame: 30 days post-operative

    Rate of readmissions due to relapsing pneumothorax (follow-up 30 days)

Sponsors and collaborators

Lead sponsor

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Other

Collaborators

  • Baxter Healthcare Corporation
  • Instituto de Investigación Biomédica de Salamanca

Registry information

Official study title

Prospective, Multicenter, Open-Label, Randomized, Phase III Clinical Trial of Prevention of Prolonged Air Leak After Lung Resection in High-risk Patients, Applying HEMOPATCH®

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 8, 2015
Registry last updated
Aug 9, 2021

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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