Effect of Tetracycline Pleurodesis on Prevention of Primary Spontaneous Pneumothorax Recurrence

Study Overview
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Brief Summary
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Primary spontaneous pneumothorax (PSP) defines as presence of air in chest cavity occurs most commonly in young, tall, and smoker men without underlying lung disease. 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.

Official Title
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Assessment of Tetracycline Pleurodesis in Prevention of Primary Spontaneous Pneumothorax Recurrence in Patients With Normal CT-scan

Conditions
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Primary Spontaneous Pneumothorax

Intervention / Treatment
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* Procedure: Chemical pleurodesis
* Drug: Tetracycline Topical Ointment
* Drug: Normal saline
* Drug: Lidocaine 2% Injectable Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First episode of primary spontaneous pneumothorax Do not have bullae in CT-scan No history of chest trauma or thoracic surgery Exclusion Criteria: History of chest trauma or thoracic surgery and start/quiting of smoking during past year. Not willing to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Case Group<br>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 | Procedure: Chemical pleurodesis<br> <br> Drug: Tetracycline Topical Ointment<br> <br> Drug: Normal saline<br> <br> Drug: Lidocaine 2% Injectable Solution<br> <br> |
| Placebo Comparator: Control Group<br>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 | Procedure: Chemical pleurodesis<br> <br> Drug: Normal saline<br> <br> Drug: Lidocaine 2% Injectable Solution<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | Evaluation of recurrence of primary spontaneous pneumothorax in 2 study groups | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tetracycline, Pleurodesis