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The Efficacy of OK-432 Pleurodesis on Postoperative Air Leak

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What is being tested

OK-432 pleurodesis

+ normal saline pleurodesis

Drug
Who is being recruted

From 20 to 70 Years
+2 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2015
See protocol details

Summary

Principal SponsorNational Taiwan University Hospital
Study ContactPei-Yin HsiehMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2015

Actual date on which the first participant was enrolled.

\[Background and Objective\] :Air leak produced after thoracic surgery is a common phenomenon.Prolonged chest tube placement can lead to empyema or infection, and extended hospitalization or even death. In 2010 many researchers reported that The incidence of lung resection produce air leak about 8-26% (Singhal et al., 2010), and even up to 50% (Mueller \& Marzluf, 2014).How to effectively treatment is still not clear.The chemical pleurodesis is an effective option in management of air leak.There are several chemical agents for pleurodesis, such as tetracycline and minocycline, talc, Taurolidine, bleomycin, iodopovidone, picibanil (OK-432), silver nitrate, quinacrine. What kind of chemical agent effective remain controversial. A study evaluated after thoracoscopic operation for primary spontaneous pneumothorax the safety and efficacy of chemical pleurodesis with a comparison between minocycline and OK-432. The OK-432 pleurodesis (19 patients) as the primary treatment and the primary success rate was 95%.(How et al., 2014).Another retrospective case-control study examining post-isolated lobectomies and bilobectomies by thoracotomy of Persistent air leak,sclerosis (talc, bleomycin, minocycline, doxycycline)for the treatment of prolonged air leak was successful in 40 of 41 patients (the success rate of 97.6%) (Liberman et al., 2010). The prolonged air leaks after major pulmonary resection still no empirical treatment of clinical research. Hypothesis: patients were persistent air leak after 48 hours chest surgery will perform OK-432 pleurodesis .The chest tube time can reduce and length of hospital stay. Extended applications can significantly reduce medical costs and manpower, and to explore OK -432 pleurodesis side effects and treatment.

Official TitleThe Efficacy of OK-432 Pleurodesis on Postoperative Air Leak
NCT02502643
Principal SponsorNational Taiwan University Hospital
Study ContactPei-Yin HsiehMore contacts
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

1 inclusion criteria required to participate
Patients were eligible for this study if they were more than 20 and less than 70 years old of age and under thoracic surgery that air leak lasting more than 48 hours form chest drainage bottles.

1 exclusion criteria prevent from participating
penicillin allergy, primary pneumothorax, esophageal cancer, immune dysfunction, those who can not sign a consent form, and pregnant or lactating, other serious concomitant illness such as uremia or liver cirrhosis.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Picibanil ( OK-432 ) ,OK-432 (KE Z Klinische Einbeit; 1 KE contains 0.1 mg of dried cocci; UKIMA PLANT OF CHUGAI PHARMA MANUFACTURING CO, LTD; JAPAN).

Group II

Active Comparator
(Normal Saline),Isotonic Sodium Chloride Solution

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

National Taiwan University Hospital

Taipei, TaiwanOpen National Taiwan University Hospital in Google Maps
SuspendedOne Study Center