NCT03634605

Effect of Tetracycline Pleurodesis on Prevention of Primary Spontaneous Pneumothorax Recurrence

Completed NA Last updated 21 August 2018

What this trial tests

NA trial testing Chemical pleurodesis in Primary Spontaneous Pneumothorax in 50 participants. Completed in 10 November 2016.

Timeline

5 May 2015

Primary endpoint
22 October 2016

10 November 2016

Quick facts

Lead sponsor	Isfahan University of Medical Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	50
Start date	5 May 2015
Primary completion	22 October 2016
Estimated completion	10 November 2016
Sites	1 location across Iran

Drugs / interventions tested

• Chemical pleurodesis
• Tetracycline Topical Ointment — full drug profile →
• Normal saline
• Lidocaine 2% Injectable Solution — full drug profile →

Conditions studied

• Primary Spontaneous Pneumothorax — all drugs for Primary Spontaneous Pneumothorax →

Sponsor

Isfahan University of Medical Sciences

Who can join

Adults 18 to 45, any sex, with Primary Spontaneous Pneumothorax. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Assessment of Tetracycline Pleurodesis in Primary Spontaneous Pneumothorax.
   Mohajeri G, Kolahduzan M, Fakhrolmobasheri M, Talebzadeh H. · · 2025 · PMID 40958924 · DOI 10.4103/abr.abr_342_22