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Effect of Tetracycline Pleurodesis on Prevention of Primary Spontaneous Pneumothorax Recurrence

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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

Tracking Information
First Submitted Date  ICMJE August 13, 2018
First Posted Date  ICMJE August 16, 2018
Last Update Posted Date August 21, 2018
Actual Study Start Date  ICMJE May 5, 2015
Actual Primary Completion Date October 22, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2018)
Recurrence [ Time Frame: 12 months ]
Evaluation of recurrence of primary spontaneous pneumothorax in 2 study groups
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03634605 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Tetracycline Pleurodesis on Prevention of Primary Spontaneous Pneumothorax Recurrence
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE Primary Spontaneous Pneumothorax
Intervention  ICMJE
  • Procedure: Chemical pleurodesis
  • Drug: Tetracycline Topical Ointment
  • Drug: Normal saline
  • Drug: Lidocaine 2% Injectable Solution
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2018)
50
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 10, 2016
Actual Primary Completion Date October 22, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03634605
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Leila Dehghani, Isfahan University of Medical Sciences
Study Sponsor  ICMJE Isfahan University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Isfahan University of Medical Sciences
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP