Effect of Tetracycline Pleurodesis on Prevention of Primary Spontaneous Pneumothorax Recurrence

• ClinicalTrials.gov Identifier: NCT03634605
• Recruitment Status: Completed
• First Posted: August 16, 2018
• Last Update Posted: August 21, 2018
• Sponsor: Isfahan University of Medical Sciences
• Information provided by (Responsible Party): Leila Dehghani, Isfahan University of Medical Sciences

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Primary Spontaneous Pneumothorax	Procedure: Chemical pleurodesis; Drug: Tetracycline Topical Ointment; Drug: Normal saline; Drug: Lidocaine 2% Injectable Solution	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Prevention
• Official Title: Assessment of Tetracycline Pleurodesis in Prevention of Primary Spontaneous Pneumothorax Recurrence in Patients With Normal CT-scan
• Actual Study Start Date: May 5, 2015
• Actual Primary Completion Date: October 22, 2016
• Actual Study Completion Date: November 10, 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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	Procedure: Chemical pleurodesis; Drug: Tetracycline Topical Ointment; Drug: Normal saline; Drug: Lidocaine 2% Injectable Solution
Placebo Comparator: 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	Procedure: Chemical pleurodesis; Drug: Normal saline; Drug: Lidocaine 2% Injectable Solution

Outcome Measures

Primary Outcome Measures :

1. Recurrence [ Time Frame: 12 months ]
   Evaluation of recurrence of primary spontaneous pneumothorax in 2 study groups

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Iran, Islamic Republic of

Isfahan Unviersity of medical Sciences

Isfahan, Iran, Islamic Republic of, 8174673461

Sponsors and Collaborators

Isfahan University of Medical Sciences

More Information

• Responsible Party: Leila Dehghani, Assistant professor, Isfahan University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT03634605 History of Changes
• Other Study ID Numbers: 395351
• First Posted: August 16, 2018
• Last Update Posted: August 21, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Leila Dehghani, Isfahan University of Medical Sciences:

Tetracycline; Pleurodesis

Additional relevant MeSH terms:

Tetracycline; Pneumothorax; Recurrence; Disease Attributes; Pathologic Processes; Pleural Diseases; Respiratory Tract Diseases; Lidocaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Anti-Bacterial Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors