PCL (Poly-ε-caprolactone) Mesh Pleurodesis

July 19, 2017 updated by: National Taiwan University Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ke-Cheng Chen, M.D., Ph.D.
  • Phone Number: +886975363798
  • Email: cskchen@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary spontaneous pneumothorax patients who require thoracoscopic bullectomy and pleurodesis

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PCL mesh group
Intervention: The participants will be received thoracoscopic bullectomy and abrasion of pleura, then PCL mesh will be applied over the lung.
Combination product: PCL mesh pleurodesis
Coverage of the lung surface by PCL mesh

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
blood pressure and temperature
Time Frame: three days
mmHg and celsius degree
three days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
pain scale
Time Frame: 3 days, 1 month and 6 months
from 0 to 9
3 days, 1 month and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jin-Shing Chen, M.D., Ph.D., National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1060006968

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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