Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Tetracycline Pleurodesis on Prevention of Primary Spontaneous Pneumothorax Recurrence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03634605
Recruitment Status : Completed
First Posted : August 16, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Leila Dehghani, Isfahan University of Medical Sciences

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

Layout table for study information
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


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



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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03634605


Locations
Layout table for location information
Iran, Islamic Republic of
Isfahan Unviersity of medical Sciences
Isfahan, Iran, Islamic Republic of, 8174673461
Sponsors and Collaborators
Isfahan University of Medical Sciences

Layout table for additonal 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    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Pneumothorax
Recurrence
Disease Attributes
Pathologic Processes
Pleural Diseases
Respiratory Tract Diseases
Tetracycline
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