Effect of Tetracycline Pleurodesis on Prevention of Primary Spontaneous Pneumothorax Recurrence

Sponsor

Isfahan University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT03634605

Collaborator

(none)

Enrollment

Location

Arms

18.2

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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	N/A

Study Design

Study Type:

Interventional

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 :

Oct 22, 2016

Actual Study Completion Date :

Nov 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

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

Recurrence [12 months]
Evaluation of recurrence of primary spontaneous pneumothorax in 2 study groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	Isfahan Unviersity of medical Sciences	Isfahan		Iran, Islamic Republic of	8174673461

Sponsors and Collaborators

Isfahan University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Leila Dehghani, Assistant professor, Isfahan University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT03634605

Other Study ID Numbers:

395351

First Posted:

Aug 16, 2018

Last Update Posted:

Aug 21, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Leila Dehghani, Assistant professor, Isfahan University of Medical Sciences

Tetracycline

Pleurodesis

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 21, 2018