Effect of Tetracycline Pleurodesis on Prevention of Primary Spontaneous Pneumothorax Recurrence
Primary Purpose
Primary Spontaneous Pneumothorax
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Chemical pleurodesis
Tetracycline Topical Ointment
Normal saline
Lidocaine 2% Injectable Solution
Sponsored by
About this trial
This is an interventional prevention trial for Primary Spontaneous Pneumothorax focused on measuring Tetracycline, Pleurodesis
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
Sites / Locations
- Isfahan Unviersity of medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Case Group
Control Group
Arm Description
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
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
Outcomes
Primary Outcome Measures
Recurrence
Evaluation of recurrence of primary spontaneous pneumothorax in 2 study groups
Secondary Outcome Measures
Full Information
NCT ID
NCT03634605
First Posted
August 13, 2018
Last Updated
August 18, 2018
Sponsor
Isfahan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03634605
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 5, 2015 (Actual)
Primary Completion Date
October 22, 2016 (Actual)
Study Completion Date
November 10, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Spontaneous Pneumothorax
Keywords
Tetracycline, Pleurodesis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Case Group
Arm Type
Experimental
Arm Description
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
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Chemical pleurodesis
Intervention Type
Drug
Intervention Name(s)
Tetracycline Topical Ointment
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Type
Drug
Intervention Name(s)
Lidocaine 2% Injectable Solution
Primary Outcome Measure Information:
Title
Recurrence
Description
Evaluation of recurrence of primary spontaneous pneumothorax in 2 study groups
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Isfahan Unviersity of medical Sciences
City
Isfahan
ZIP/Postal Code
8174673461
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Tetracycline Pleurodesis on Prevention of Primary Spontaneous Pneumothorax Recurrence
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