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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-24

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02668978

LUNG DISEASES

COMPLETED PHASE4

A Phase II Prospective, Single Blinded, Randomized Trial of Hemopatch Compared to Standard Techniques to Achieve Air Leak Control After Complex Thoracic Surgical Procedures

NCT02364791

Thoracic Surgery Lung Post-operative Thoracic Air Leak

UNKNOWN PHASE2

Hemopatch Compared to TachoSil in Postoperative Air Leak Duration After Pulmonary Resection

NCT03450265

Air Leak From Lung

COMPLETED NA

Prolonged Air Leak (PAL) Autologous Blood Patch Intervention Trial

NCT04954625

Lung Cancer

ENROLLING_BY_INVITATION NA

Observational Study of TissuePatch SF in Prevention of Air Leaks Following Lung Resection

NCT06934486

Post-operative Air Leaks

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prolonged Air Leak Lung Resection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental group

Experimental group: At the end of lung resection, lung sutures and 1.5 cm of lung parenchyma on each side will be covered by Hemopatch. No additional measures for preventing air leak will be indicated. In the case of massive air leak in spite of the use of Hemopatch, each surgeon will decide on the indication of additional sutures of tissue plasties. These cases will be accounted for failures on an intention to treat basis.

Group Type EXPERIMENTAL

Hemopatch

Intervention Type DEVICE

standard preventive measures

Intervention Type PROCEDURE

Control group

Control group: The standard preventive measures will be followed in each center, including reinforcement of sutures, pleural tents, suturing pericardial or subcutaneous fat

Group Type OTHER

standard preventive measures

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hemopatch

Intervention Type DEVICE

standard preventive measures

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No