Air Leak Management for Pneumothorax

(CT0128 Trial)

Recruiting at 1 trial location

Overseen By Moishe Liberman, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Disqualifiers: Healthy individuals

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to improve methods for detecting and repairing air leaks during lung surgery using a bio-adhesive, known as BioGlue or Albumin-Glutaraldehyde Tissue Adhesive. The goal is to reduce post-surgery complications and speed up patient recovery. Researchers are testing this on lungs removed during lung transplants. Patients undergoing lung transplant surgery, whose lungs cannot be donated, might be suitable for this trial. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance surgical outcomes and recovery times.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this methodology is safe for air leak management?

Research shows that the bio-adhesive being tested for managing air leaks in lung surgery appears promising. One study demonstrated that a similar adhesive significantly shortened the duration of air leaks. On average, leaks lasted less than half a day with the adhesive, compared to almost four days without it. This suggests that the adhesive can effectively seal lung tissue to prevent leaks.

Regarding safety, earlier studies on similar adhesives used in surgeries indicate they are generally well-tolerated. No major reports of harmful side effects have been directly linked to the adhesive in these studies. This suggests it could be a safe option for reducing air leaks during lung surgery. However, as with any treatment, individual reactions can vary, and more studies are likely being conducted to confirm its safety for this specific use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for pneumothorax, such as chest tubes and surgery, focus on removing the air leak indirectly or repairing the lung tissue invasively. But this new bio-adhesive treatment works differently by directly sealing the air leak with a special glue-like substance. Researchers are excited because this adhesive can be applied quickly and non-invasively, potentially reducing recovery time and complications compared to traditional methods. Plus, it mimics the natural healing process, which could make it a more efficient and patient-friendly option.

What evidence suggests that this bio-adhesive is effective for managing air leaks in pneumothorax?

This trial studies the use of a special glue, such as BioGlue, for treating air leaks in the lungs. Research has shown that BioGlue can reduce the duration of these leaks and shorten the time patients need chest tubes after lung surgery. As a result, patients may spend less time in the hospital and face fewer complications post-surgery. The glue seals the leaks in the lung tissue, promoting faster healing. Overall, the trial evaluates its potential to manage air leaks during and after lung operations. ^{3 4 6 7 8}

Who Is on the Research Team?

Moishe Liberman, MD

Principal Investigator

CHUM

Are You a Good Fit for This Trial?

This trial is for patients undergoing lung transplant surgery who cannot donate their lungs. It's not open to healthy individuals.

Inclusion Criteria

I am scheduled for a lung transplant surgery.

I cannot donate my lungs.

Exclusion Criteria

Healthy individuals

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental Procedures

Development and testing of air leak detection and treatment methodologies using ex-vivo human lung models

48 months

Multiple procedures performed on lung models

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bio-adhesive

Trial Overview

The study aims to develop a method to detect, measure, and treat air leaks during surgery using a bio-adhesive. This could reduce complications and hospital stays after lung surgeries.

How Is the Trial Designed?

Group I: Air Leaks Experimental Treatment 1 Intervention

Lungs from patients undergoing lung transplantation after their removal from the recipient patient with previous informed consent signed before transplantation will be obtained. The organs will be placed in an acrylic box and will be kept at a temperature of 37 Celsius degrees. In order to reproduce intraoperative air leaks, various manipulations, including stapling and creating lacerations of different depts and lengths on the parenchyma, will be performed on deflated lungs. Following the introduction of a leak, condensed gas will be pushed through the airway to precisely localize the defect. The sealant prepared at room temperature will then be applied in a thin layer to cover the defect and will be left to dry for 5 minutes. The seal will be tested using the condensed gas with the lung still deflated as well as with the water immersion technique after inflating the lung.

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Published Research Related to This Trial

The modified technique using a square silicone frame for applying albumin-glutaraldehyde glue significantly improved the sealing efficacy for alveolar air leaks in swine lungs, achieving higher burst pressures compared to the standard method.

In a study involving 20 swine lungs, the frame-assisted application resulted in better sealing outcomes at various tidal volumes, suggesting that this technique may reduce glue run-off and enhance treatment effectiveness, warranting further clinical investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved application technique of albumin-glutaraldehyde glue for repair of superficial lung defects. Bures, M., Zardo, P., Länger, F., et al.[2019]

In an in vitro study using swine lungs, BioGlue™ demonstrated high sealing efficacy for superficial lung defects, successfully sealing defects in a majority of cases at lower tidal volumes.

However, the glue's rigid nature may pose risks in certain conditions, such as trapped lungs, indicating that while it is effective, careful consideration is needed for its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Albumin-glutaraldehyde glue for repair of superficial lung defect: an in vitro experiment. Bures, M., Höffler, HK., Friedel, G., et al.[2019]

In a study of 21 patients who underwent bullectomy, the use of BioGlue Surgical Adhesive significantly reduced the duration of air leaks to an average of 0.42 days compared to 3.68 days in a control group of 19 patients.

BioGlue also decreased the time for chest tube drainage from an average of 5.42 days in the control group to 2.33 days, with no reported complications or mortality, indicating it is a safe and effective option for improving postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with an albumin-glutaraldehyde tissue adhesive in sealing air leaks after bullectomy. Potaris, K., Mihos, P., Gakidis, I.[2019]

In a case involving a 50-year-old patient with a trapped lung, the direct instillation of Bioglue™ into a deep crater during thoracic surgery significantly reduced a challenging air leak, facilitating easier ventilation and extubation.

This technique suggests that Bioglue™ can be an effective option for managing complicated air leaks in thoracic surgery, particularly when traditional methods are insufficient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Bioglue™ to seal a difficult to treat air leak in a complicated empyema patient. Kouritas, V., Kefaloyannis, E., Tcherveniakov, P.[2018]

BioGlue Surgical Adhesive was found to be safe and effective for sealing air leaks in the lungs, with a median air leak duration of just 1 day in a study of 38 patients undergoing various thoracic surgeries.

The adhesive successfully sealed bronchopleural fistulas and prevented air leakage from surgical sites, demonstrating its utility in complex lung procedures, with only 8% of patients experiencing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary results with the use of an albumin-glutaraldehyde tissue adhesive in lung surgery. Potaris, K., Mihos, P., Gakidis, I.[2019]

In a retrospective study of 40 patients undergoing thoracic surgery, BioGlue was effective in controlling alveolar air leaks in 35 out of 36 cases, indicating its potential as a reliable adhesive in surgical procedures.

The study suggests that BioGlue may reduce complications like air leaks and broncho-pleural fistulae, although further research is needed to compare its efficacy with other sealants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioglue: a review of the use of this new surgical adhesive in thoracic surgery. Passage, J., Tam, R., Windsor, M., et al.[2005]

BioGlue, a sealant used for aortic dissections, releases significant amounts of glutaraldehyde (100 to 200 µg/mL), which has been shown to be cytotoxic to cultured cells, indicating potential safety concerns.

In vivo studies on rabbits revealed that while BioGlue caused severe inflammation and tissue damage in lung and liver tissues, it only induced low to medium-grade inflammation in aortic tissue, suggesting that its use should be limited to aortic procedures due to the sensitivity of other tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Release of glutaraldehyde from an albumin-glutaraldehyde tissue adhesive causes significant in vitro and in vivo toxicity. Fürst, W., Banerjee, A.[2013]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/16798309/

A prospective, randomized, controlled trial of the ...

Conclusions: This study demonstrates clear benefit from BioGlue in the treatment of alveolar air leaks through reduction of air leak duration, chest drainage ...

2.

jtcvs.org

jtcvs.org/article/S0022-5223(06)00408-9/fulltext

A prospective, randomized, controlled trial of the ...

Conclusions. This study demonstrates clear benefit from BioGlue in the treatment of alveolar air leaks through reduction of air leak duration, chest drainage ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/14721826/

Experience with an albumin-glutaraldehyde tissue ...

The use of BioGlue as a surgical lung sealant significantly decreased the duration of postoperative air leaks and the time to chest tube removal.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0022522306004089

A prospective, randomized, controlled trial of the ...

Conclusions. This study demonstrates clear benefit from BioGlue in the treatment of alveolar air leaks through reduction of air leak duration, chest drainage ...

5.

journal.hsforum.com

journal.hsforum.com/index.php/HSF/article/download/556/560/562

Experience with an Albumin-Glutaraldehyde Tissue ...

Conclusions: The use of BioGlue as a surgical lung sealant significantly decreased the duration of postoperative air leaks and the time to chest tube removal.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5393991/

The role of BioGlue in thoracic surgery: a systematic review

Regarding the prevention of air leak, BioGlue was mainly utilized at the time of initial operation (9,14-16), except for six cases (172/178), in whom prolonged ...

7.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf/p010003b.pdf

CryoLife, Inc., BioGlue® Surgical Adhesive - accessdata.fda.gov

The overall objective was to collect clinical data concerning the safety and effectiveness of BioGlue used as an anastomotic sealant to provide hemostasis. The ...

8.

academic.oup.com

academic.oup.com/ejcts/article/19/1/4/391998

Experimental use of an albumin–glutaraldehyde tissue ...

Results: Bronchial anastomosis and parenchymal tissue repair can be sealed successfully against air leakage with adhesive. Macroscopic evaluation revealed a ...