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PCL (Poly-ε-caprolactone) Mesh Pleurodesis

PCL (Poly-ε-caprolactone) Mesh Pleurodesis in Thoracoscopic Treatment of Primary Spontaneous Pneumothorax

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03227978
Enrollment
10
Registered
2017-07-24
Start date
2017-08-01
Completion date
2019-07-31
Last updated
2017-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PCL Pleurodesis

Keywords

pleurodesis, PCL

Brief summary

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.

Detailed description

Primary spontaneous pneumothorax usually occurs in young, lean young men. In most cases, the cause of pneumothorax is rupture of blebs at the apex of the lung. Traditionally, bullectomy with mechanical pleurodesis through thoracotomy is indicated in patients with recurrence or persisted air leakage. The possible causes of recurrent pneumothorax and prolonged air leakage are missed bleb surrounding the endoscopic suture line or suboptimal suturing or healing of the thoracoscopic suture. To prevent these complications, a novel method using coverage of the endoscopic suture line by a large absorbable vicryl mesh during thoracoscopic surgery was proved to be safe and feasible. Theoretically, the mesh can strengthen the suture line and induce local fibrosis surrounding the suture line, and reduce the rate of recurrent pneumothorax and prolonged air leakage. To prove this hypothesis, we will conduct a prospective randomized trial in National Taiwan University Hospital. We will enroll 10 patients with primary spontaneous pneumothorax who will be assigned to PCL mesh pleurodesis after thoracoscopic bullectomy and pleural abrasion. The primary endpoint is to check the biocompatibility of PCL mesh. The secondary endpoint is to evaluate the safety after thoracoscopic bullectomy and pleural abrasion.

Interventions

COMBINATION_PRODUCTPCL mesh pleurodesis

Coverage of the lung surface by PCL mesh

Sponsors

National Taiwan University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Primary spontaneous pneumothorax patients who require thoracoscopic bullectomy and pleurodesis

Exclusion criteria

* chronic obstructive pulmonary disease, hemopneumothorax, catamenial pneumothorax, pregnant, malignancy

Design outcomes

Primary

MeasureTime frameDescription
blood pressure and temperaturethree daysmmHg and celsius degree

Secondary

MeasureTime frameDescription
pain scale3 days, 1 month and 6 monthsfrom 0 to 9

Contacts

Primary ContactKe-Cheng Chen, M.D., Ph.D.
cskchen@gmail.com+886975363798

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026