NCT03634605

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2016

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2016

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

1.5 years

First QC Date

August 13, 2018

Last Update Submit

August 18, 2018

Conditions

Primary Spontaneous Pneumothorax

Keywords

TetracyclinePleurodesis

Outcome Measures

Primary Outcomes (1)

  • Recurrence

    Evaluation of recurrence of primary spontaneous pneumothorax in 2 study groups

    12 months

Study Arms (2)

Case Group

EXPERIMENTAL

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 pleurodesisDrug: Tetracycline Topical OintmentDrug: Normal salineDrug: Lidocaine 2% Injectable Solution

Control Group

PLACEBO COMPARATOR

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 pleurodesisDrug: Normal salineDrug: Lidocaine 2% Injectable Solution

Interventions

Chemical pleurodesisPROCEDURE
Case GroupControl Group
Tetracycline Topical OintmentDRUG
Case Group
Normal salineDRUG
Case GroupControl Group
Lidocaine 2% Injectable SolutionDRUG
Case GroupControl Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • First episode of primary spontaneous pneumothorax
  • Do not have bullae in CT-scan
  • No history of chest trauma or thoracic surgery

You may not qualify if:

  • History of chest trauma or thoracic surgery and start/quiting of smoking during past year.
  • Not willing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isfahan Unviersity of medical Sciences

Isfahan, 8174673461, Iran

Location

MeSH Terms

Conditions

Pneumothorax

Interventions

Saline SolutionLidocaine

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 16, 2018

Study Start

May 5, 2015

Primary Completion

October 22, 2016

Study Completion

November 10, 2016

Last Updated

August 21, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)