The Efficacy of OK-432 Pleurodesis on Postoperative Air Leak
关键词
抽象
描述
[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.
日期
| 最后验证: | 09/30/2016 |
| 首次提交: | 07/14/2015 |
| 提交的预估入学人数: | 07/16/2015 |
| 首次发布: | 07/19/2015 |
| 上次提交的更新: | 10/12/2016 |
| 最近更新发布: | 10/13/2016 |
| 实际学习开始日期: | 06/30/2015 |
| 预计主要完成日期: | 06/30/2018 |
| 预计完成日期: | 06/30/2018 |
状况或疾病
干预/治疗
Drug: OK-432 pleurodesis
Drug: normal saline pleurodesis
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: OK-432 pleurodesis 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 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 |
| Active Comparator: normal saline pleurodesis (Normal Saline),Isotonic Sodium Chloride Solution | Drug: normal saline pleurodesis 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 |
资格标准
| 有资格学习的年龄 | 20 Years 至 20 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion criteria: - 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. Exclusion criteria : - 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. |
结果
主要结果指标
1. OK-432 success rate [48 hours]
次要成果指标
1. OK-432 side effects [48 hours]
