Air Leak Management for Pneumothorax

(CT0128 Trial)

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

Trial Summary

What is the purpose of this trial?

Developing a methodology to detect, quantify and treat air leaks intraoperatively using a bio-adhesive, to thereby reduce postoperative surgical complications, morbidity, and length of stay for patients undergoing pulmonary resection.

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 data supports the effectiveness of the treatment BioGlue for managing air leaks in pneumothorax?

Research shows that BioGlue, an albumin-glutaraldehyde tissue adhesive, is effective in sealing air leaks in lung surgeries, such as after bullectomy (removal of air-filled sacs in the lung) and in treating alveolar air leaks (small air leaks in the lung). This suggests it could be helpful for managing air leaks in pneumothorax (collapsed lung). ^{1 2 3 4 5}

Is BioGlue safe for use in humans?

BioGlue, an albumin-glutaraldehyde tissue adhesive, has been used in various surgeries, but it can release glutaraldehyde, which may cause toxicity in tissues. While it is effective in sealing air leaks, its potential toxic effects should be considered. ^{1 3 4 5 6}

How does the treatment for pneumothorax using BioGlue differ from other treatments?

BioGlue, an albumin-glutaraldehyde tissue adhesive, is unique because it directly seals air leaks in the lungs, which can be difficult to treat with other methods. Unlike traditional treatments, BioGlue is applied directly to the lung defect, where it polymerizes (hardens) to effectively stop air leaks, making it a novel option for managing complicated cases. ^{1 2 3 5 7}

Research Team

Moishe Liberman, MD

Principal Investigator

CHUM

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Preliminary results with the use of an albumin-glutaraldehyde tissue adhesive in lung surgery. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Improved application technique of albumin-glutaraldehyde glue for repair of superficial lung defects. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Albumin-glutaraldehyde glue for repair of superficial lung defect: an in vitro experiment. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Experience with an albumin-glutaraldehyde tissue adhesive in sealing air leaks after bullectomy. [2019]

5. Australia pubmed.ncbi.nlm.nih.gov

Bioglue: a review of the use of this new surgical adhesive in thoracic surgery. [2005]

6. Netherlands pubmed.ncbi.nlm.nih.gov

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

7. Japan pubmed.ncbi.nlm.nih.gov

Use of Bioglue™ to seal a difficult to treat air leak in a complicated empyema patient. [2018]