PCL Pleurodesis Clinical Trial
Official title:
PCL (Poly-ε-caprolactone) Mesh Pleurodesis in Thoracoscopic Treatment of Primary Spontaneous Pneumothorax
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.
| Status | Not yet recruiting |
| Enrollment | 10 |
| Est. completion date | July 31, 2019 |
| Est. primary completion date | July 31, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 50 Years |
| Eligibility |
Inclusion Criteria: - Primary spontaneous pneumothorax patients who require thoracoscopic bullectomy and pleurodesis Exclusion Criteria: - chronic obstructive pulmonary disease, hemopneumothorax, catamenial pneumothorax, pregnant, malignancy |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| National Taiwan University Hospital |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | blood pressure and temperature | mmHg and celsius degree | three days | |
| Secondary | pain scale | from 0 to 9 | 3 days, 1 month and 6 months |