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Trial record 4 of 25 for:    "Pleural Disease" | "Anti-Bacterial Agents"

Intrapleural Minocycline Following Simple Aspiration for Primary Spontaneous Pneumothorax

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00520221
Recruitment Status : Completed
First Posted : August 23, 2007
Last Update Posted : August 23, 2007
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Information provided by:
National Taiwan University Hospital

Brief Summary:
The optimal initial management of primary spontaneous pneumothorax (PSP) remains controversial. This study was conducted to evaluate the safety and efficacy of additional minocycline pleurodesis after successful aspiration of the first episode of PSP.

Condition or disease

Detailed Description:

Primary spontaneous pneumothorax (PSP) most commonly occurs in young, tall, lean males. The estimated recurrence rate is 23-50% after the first episode. The high recurrence rate stimulated the development of many different therapeutic approaches, ranging from conservative treatment such as observation to more invasive therapies such as surgery, and optimal treatment of patients presenting with a first episode of PSP remains controversial. In the recently published British Thoracic Society (BTS) guidelines, simple aspiration is recommended as the first line treatment for all PSP requiring intervention because this treatment provided the advantage of reduced hospital admission rate and reduced length of hospital stay when compared with chest tube drainage. However, the recurrence rate of this procedure was around 30%, making it inappropriate as a standard of care.

Intrapleural instillation of a chemical irritant (chemical pleurodesis) is an effective way to reduce the rates of recurrent spontaneous pneumothorax in surgical and non-surgical patients. Previously, chemical pleurodesis had usually been administrated through chest tube or thoracoscopy. Administration of sclerosing agents through intravenous needle catheter or pigtail catheter after simple aspiration had never been reported and the safety and efficacy remained unknown.

Because the recurrence rate after simple aspiration remains high, we began to instill minocycline into the pleural cavity through the pigtail or intravenous needle catheter since December 2005 to determine if this adjuvant is effective in reducing the rate of recurrence. In the present study, we report our experience of minocycline pleurodesis in treating first episode of PSP after successful aspiration of pneumothorax. The effects of this adjuvant therapy were evaluated by comparing the outcomes of the patients who underwent simple aspiration alone with those who underwent additional minocycline pleurodesis.

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Study Type : Observational
Actual Enrollment : 64 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective
Official Title: Intrapleural Minocycline Following Simple Aspiration for Initial Treatment of Primary Spontaneous Pneumothorax: a Retrospective Study
Study Start Date : January 2004
Actual Study Completion Date : July 2007

Treatment Comparison: 2

Minocycline group: 300 mg of minocycline hydrochloride was instilled into the pleural space through the catheter.

Control group consisted of 33 patients who had successful simple aspiration alone between January 2004 and December 2005.

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Primary spontaneous pneumothorax patients who underwent manual aspiration as their initial treatment were selected.

Exclusion Criteria:

  • Patients with a previous history of spontaneous pneumothorax, >50 years of age, or with preexisting pulmonary diseases were excluded. Patients with unsuccessful aspiration requiring further chest tube insertion or thoracoscopic operation were also excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00520221

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National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Department of Health, Executive Yuan, R.O.C. (Taiwan)
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Study Chair: Yung-Chie Lee, MD, PhD Department of Surgery, National Taiwan University Hospital, Taiwan
Study Director: Jin-Shing Chen, MD, PhD Department of Surgery, National Taiwan University Hospital, Taiwan

Layout table for additonal information Identifier: NCT00520221     History of Changes
Other Study ID Numbers: 200707015R
First Posted: August 23, 2007    Key Record Dates
Last Update Posted: August 23, 2007
Last Verified: January 2004
Keywords provided by National Taiwan University Hospital:
Primary spontaneous pneumothorax
First attack
Successful aspiration
Additional relevant MeSH terms:
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Pleural Diseases
Respiratory Tract Diseases
Anti-Bacterial Agents
Anti-Infective Agents