Effect of Tetracycline Pleurodesis on Prevention of Primary Spontaneous Pneumothorax Recurrence

Isfahan University of Medical Sciences

Status: Completed

Conditions: Primary Spontaneous Pneumothorax

Treatments: Drug: Tetracycline Topical Ointment; Procedure: Chemical pleurodesis; Drug: Lidocaine 2% Injectable Solution; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03634605

395351

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

50 participants in 2 patient groups, including a placebo group

Case Group

Experimental group

Description:

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

Treatment:

Drug: Normal saline

Drug: Lidocaine 2% Injectable Solution

Procedure: Chemical pleurodesis

Drug: Tetracycline Topical Ointment

Control Group

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal saline

Drug: Lidocaine 2% Injectable Solution

Procedure: Chemical pleurodesis