PCL Pleurodesis clinical trials

PCL (Poly-ε-caprolactone) Mesh Pleurodesis

Recent advances in thoracoscopic surgery have made it a commonly used technique for treating spontaneous pneumothoraces and preventing recurrence. The goal of surgical treatment is to find the offending bleb, remove it, and do some manipulation to encourage pleural symphysis. Methods of thoracoscopic pleural symphysis have included mechanical abrasion and instillation of chemical irritants. Each method reduces the rate of pneumothorax recurrence to a certain degree, but the recurrence rates after thoracoscopic surgery are widely varied in the literature. Although several articles show significantly lower rates, there are also articles demonstrating that the recurrence rates of pneumothorax after thoracoscopic surgery ranged between 5 and 12%, which are higher than the rates reported after open thoracotomy. It is suggested that a less intense pleural inflammatory reaction is induced by thoracoscopic procedure than by thoracotomy. Besides, post-pleurodesis severe pain and bleeding were encountered frequently. A potential alternative to increase the intensity of pleural inflammation and thereby prevent pneumothorax recurrence is film pleurodesis. Only few studies have been reported where more than one film pleurodesis has been tried, and the mechanism of film pleurodesis remains unclear. Poly-ε-caprolactone (PCL) is a FDA-approved biomaterial with a slow degradation time of approximately 24 months when degraded by hydrolysis only. Recently, some investigators combined PCL with other biomaterials such as chitosan, polyethylene glycol, hyaluronic acid to produce anti-adhesion barrier for clinical applications. However, only few studies report PCL only could provide anti-adhesion effect. In contrast to common complications of postoperative abdominal adhesions, adhesion (or pleurodesis) is an important therapeutic tool to control the incidence of recurrent pneumothorax. We suppose that if a biomaterial induces adhesion following abdominal surgery, perhaps it may be applied to pleurodesis tool for preventing recurrence of spontaneous pneumothorax. We hypothesized that PCL membrane-induced pleurodesis can be achieved intrapleurally.