The Efficacy of OK-432 Pleurodesis on Postoperative Air Leak

NCT02502643 | Unknown

• 1 other identifier: 201504066RINA
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is (1) The success rate of OK-432 pleurodesis after thoracic surgery that air leak over 48 hours (2)The side effects and treatments of OK-432 pleurodesis. \[Methods\] This study was a prospective, randomized, open-label, controlled study to evaluate the effectiveness of OK-432 pleurodesis of persistent air Leak after pulmonary Resection. The adult patient have persistent air leak \>48 hours after thoracic surgery, will randomized to OK-432 pleurodesis (OK-432 group) or normal saline pleurodesis (NS group). The trial will be conduct from May 25, 2015 to May 25, 2018 in the Department of Surgery at national Taiwan University Hospital, a medical center. The study protocol was approved by the hospitals' Institutional Review Boards. A total of 80 cases, the subjects will be the hospital thoracic surgery ward and received outpatient programs. Eligible Subjects : adults (minimum age\> 20 years; maximum age ≦ 70 years old) patients with thoracic surgery and over48 hours of continuous air leak. The exclusion criteria include: 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 steps: eligible Patients will randomize according to computer-generated random numbers, with 1:1 ratio in sequentially numbered, sealed envelopes by a study nurse who was masked to the study. Randomization envelopes were opened, and randomization was performed by the study nurse after informed consent was obtain. Eligible inpatients were randomized to the OK-432 group or the normal saline (NS) group，each group are 40 cases. All subjects were observed by the physician who was masked to the study， about air leak stop time, chest tube removal time, discharge time, outpatient chest X-ray, pulmonary function tests as necessary. cases if persistent air leak more than seven days, the attending physician determines whether pleurodesis again or surgery or other medical treatment. Finally, the researcher who do not know groups will collection data by "air leak case record form" including diagnosis, surgical site，the start and end time of the surgery, the use of antibiotics, discomfort problems (pain , stomach discomfort, cough, fever\> 38 ℃, allergic reactions and respiratory discomfort), postoperative air leak time, air leak stop time , chest tube removal time, discharge time, the data will be use SPSS20.0 version of the statistical software package, and T-test, pair T-test ，Anova ,linear correlation statistical methods for analysis. Outcome measures: OK-432 success rate, OK-432 side effects, air leak time, chest tube remove time, length of hospital stay.

Conditions

Postoperative Air Leak

Keywords

Safety and Efficacy; Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• OK-432 success rate

  The success rate of OK-432 was defined chest bottle no bubbles appear when coughing, then CXR was perform the next day after pleurodesis, and after cessation of the air leak,the chest tube is remove .

  48 hours

Secondary Outcomes (1)

• OK-432 side effects

  48 hours

Study Arms (2)

OK-432 pleurodesis

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).

Drug: OK-432 pleurodesis

normal saline pleurodesis

ACTIVE COMPARATOR

(Normal Saline),Isotonic Sodium Chloride Solution

Drug: normal saline pleurodesis

Interventions

OK-432 pleurodesis DRUG

1.Pain medications (if no contraindications) Before half hour; Bain (IM ,0.15mg / kg). 2. Make the patient supine position 3. Near the body of patient's chest tube is the injection site disinfection with the alcoholic Betadine and alcohol repeated three times.4. 20 cc of 2% lidocaine hydrochloride (400 mg) was instilled into the pleural cavity through the chest tube 5. A solution of 30 cc of normal saline containing 5 KE of OK-432 (KE Z Klinische Einbeit; 1 KE contains 0.1 mg of dried cocci).6. Inject air 20 cc 7. The injection site will cover with op site and the rubber tube that connecting the chest tube and chest bottle was raised 40-60 cm above the patient to trap the sclerosing agent but allow air to pass 8. Patients will reposition (left and right side)every 30 minutes in 2 hours

Also known as: Picibanil

OK-432 pleurodesis

normal saline pleurodesis DRUG

Make the patient supine position , Near the body of patient's chest tube is the injection site disinfection with the alcoholic Betadine and alcohol repeated three times.injected a solution of 30 cc of normal saline , and then injected into 20 cc air to the rubber chest tube , so that normal saline can completely into the chest, the injection site will cover with op site, use a rubber band to the rubber chest tube for hanging from the patient's body 40-60 cm high.Patients will reposition (left and right side)every 30 minutes in 2 hours

Also known as: normal saline

normal saline pleurodesis

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Test2, test3, Taiwan

RECRUITING

MeSH Terms

Interventions

Picibanil; Saline Solution

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jin-Shing Chen

  National Taiwan University Hospital

  STUDY CHAIR

Central Study Contacts

Pei-Yin Hsieh

CONTACT

886-2-23123456; peiyin3111@ntuh.gov.tw

Jin-Shing Chen

CONTACT

886-2-23123456; chenjs@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 20, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: October 14, 2016

Record last verified: 2016-10

Locations

TW (1)