Effect of Tetracycline Pleurodesis on Prevention of Primary Spontaneous Pneumothorax Recurrence
NCT ID: NCT03634605
Last Updated: 2018-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2015-05-05
2016-11-10
Brief Summary
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Trends for PSP treatment tend toward more invasive procedures. Thoracotomy with pleurectomy and bullectomy is definitive treatment of PSP which significantly reduces recurrence probability. This procedure has been reported to cause high rate of morbidity and mortality. Thus video-assisted thoracoscopic surgery (VATS) has become the preferred method for treatment of PSP with recurrence rate of 5-10%. For persistent or recurrent cases, mechanical or chemical pleurodesis have been suggested.
Based on guidelines patients with large size of lesions in CT or with unstable condition should undergo surgical procedure for recurrence prevention but Patients with small lesion size and stable condition can be only observed. Conservative management of PSP is safe and effective, but as mentioned this method has high recurrence rate. On the other hand fear of recurrence can negatively affect patients' quality of life, so that some patients prefer surgical intervention to observation management. Also some studies recommend invasive treatments because of cost effectiveness of this methods.
As mentioned above, chemical pleurodesis is a usual method for treatment in patients with persistent or recurrent spontaneous pneumothorax. This method has been done using variety of chemical agents including tetracycline, minocycline, blood, and talc to irritate pleura. According to different studies tetracycline has the highest efficacy between irritant agents.
In current study, the investigators have aimed to assess tetracycline chemical pleurodesis through tube thoracostomy in prevention of spontaneous pneumothorax in symptom free patients with normal CT-scan following first episode of PSP.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Case Group
Chemical pleurodesis for the this group was done using 2 grams of tetracycline 3% ointment (Aerotex®, Sina Daru, Tehran, Iran), 5 milliliter of lidocaine 2% and 50 milliliter normal saline that was injected through embedded thoracostomy tube
Chemical pleurodesis
Tetracycline Topical Ointment
Normal saline
Lidocaine 2% Injectable Solution
Control Group
Chemical pleurodesis for this group was done using 5 milliliter of lidocaine 2% and 50 milliliter normal saline that was injected through embedded thoracostomy tube
Chemical pleurodesis
Normal saline
Lidocaine 2% Injectable Solution
Interventions
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Chemical pleurodesis
Tetracycline Topical Ointment
Normal saline
Lidocaine 2% Injectable Solution
Eligibility Criteria
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Inclusion Criteria
* Do not have bullae in CT-scan
* No history of chest trauma or thoracic surgery
Exclusion Criteria
* Not willing to participate in the study
18 Years
45 Years
ALL
No
Sponsors
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Isfahan University of Medical Sciences
OTHER
Responsible Party
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Leila Dehghani
Assistant professor
Locations
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Isfahan Unviersity of medical Sciences
Isfahan, , Iran
Countries
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Other Identifiers
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395351
Identifier Type: -
Identifier Source: org_study_id
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