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

Tracking Information

• First Submitted Date: August 13, 2018
• First Posted Date: August 16, 2018
• Last Update Posted Date: August 21, 2018
• Actual Study Start Date: May 5, 2015
• Actual Primary Completion Date: October 22, 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 15, 2018)

Recurrence [ Time Frame: 12 months ]

Evaluation of recurrence of primary spontaneous pneumothorax in 2 study groups

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03634605 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effect of Tetracycline Pleurodesis on Prevention of Primary Spontaneous Pneumothorax Recurrence
• Official Title: Assessment of Tetracycline Pleurodesis in Prevention of Primary Spontaneous Pneumothorax Recurrence in Patients With Normal CT-scan

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Prevention
• Condition: Primary Spontaneous Pneumothorax

Intervention

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

Study Arms

• 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
  Interventions:

  • 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
  Interventions:

  • Procedure: Chemical pleurodesis
  • Drug: Normal saline
  • Drug: Lidocaine 2% Injectable Solution

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 15, 2018): 50
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: November 10, 2016
• Actual Primary Completion Date: October 22, 2016 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Iran, Islamic Republic of

Administrative Information

• NCT Number: NCT03634605
• Other Study ID Numbers: 395351
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Leila Dehghani, Isfahan University of Medical Sciences
• Study Sponsor: Isfahan University of Medical Sciences
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Isfahan University of Medical Sciences
• Verification Date: August 2018