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Antineoplastic Agents

Altretamine

Standard surgical closure (suturing or stapling of visible air leaks incurred during resection of lung parenchyma) plus Progel Pleural Air Leak Sealant.

Progel Pleural Air Leak Sealant without standard surgical closure (without suturing or stapling of visible air leaks incurred during resection of lung parenchyma).

Standard surgical techniques including staples and sutures.

Control

ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG). Standard closure means, for example, suturing or stapling of visible air leaks incurred during resection of lung parenchyma.

ProGEL Pleural Air Leak Sealant with standard surgical closure

ProGEL Pleural Air Leak Sealant without standard surgical closure

Robert J. Cerfolio, MD

Daniel L. Miller, MD

The purpose of this post approval study is to further characterize the safety profile of the ProGEL™ Pleural Air Leak Sealant in commercial use, with specific reference to long-term safety over 90 days of follow-up.

Patients having open thoracotomy involving lung resection surgery will be considered for the study. Subjects will be examined for adverse events and complications from either the treatment or the procedure. Follow-up visits are required at 30 days and 90 days after the surgery.

NeoMend ProGEL™ Pleural Air Leak Sealant Post-Approval Study

AirTight: A Prospective Controlled Post-Approval Study of NeoMend ProGEL™ Pleural Air Leak Sealant in the Treatment of Visible Pleural Air Leaks After Standard Pleural Closure

* Pulmonary adverse events: pneumothorax, persistent air leak, late onset air leak, residual pleural space, and acute respiratory distress syndrome
* Renal adverse events
* Cardiac adverse events
* Death (all causes)
* Hospital readmission

C. R. Bard

No treatment.

Control: Standard surgical techniques including staples and sutures.

ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG).

Standard surgical closure (standard closure with, sutures or staples, for example) plus Progel Pleural Air Leak Sealant.

ProGEL Pleural Air Leak Sealant With Standard Surgical Closure

ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG).

Progel Pleural Air Leak Sealant without standard surgical closure (standard closure with, sutures or staples, for example).

ProGEL Pleural Air Leak Sealant Without Standard Surgical Closure

ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG).

Standard closure, for example, by suturing or stapling, of visible air leaks incurred during resection of lung parenchyma.

ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG).

Without standard closure, for example, suturing or stapling, of visible air leaks incurred during resection of lung parenchyma.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race/Ethnicity

Race/Ethnicity, Customized

United States

Region of Enrollment

Height

Weight

Body Mass Index (BMI)

Dawn Heimer, PhD

Standard surgical technique plus Progel Pleural Air Leak Sealant.

ProGEL Pleural Air Leak Sealant: ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG).

ProGEL Pleural Air Leak Sealant

Units analyzed represents the number of adverse events that occurred among all study participants in each arm.

Also, the original Protocol was designed to study ProGel (any usage) versus no ProGel. After the study was completed, the FDA requested that the ProGel group be broken out by patients with standard closure, and without.

Spots Global Cancer Trial Database for open thoracotomy