Back to resultsPRP in 2ry Spontaneous Pneumothorax
Primary Purpose
Pneumothorax Spontaneous Secondary
Status
Unknown status
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Platelet Rich Plasma
Sponsored by
About this trial
This is an interventional treatment trial for Pneumothorax Spontaneous Secondary
Eligibility Criteria
Inclusion Criteria:
- COPD patients developed spontanous pneumothorax and was managed with intercostal tube insertion
Exclusion Criteria:
- refusal of participation
Sites / Locations
- Zagazig University Faculty of medicine Chest DepartmentRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Platelet rich plasma group
Arm Description
Outcomes
Primary Outcome Measures
Air leak assessment by Cerfolio classification of the air leak by single observer
Continuous:Air leak is Present throughout the respiratory cycle Inspiratory : Present during the inspiration phase of the respiratory cycle. Expiratory: Present only during the expiratory phase of the respiratory cycle Forced expiration: Present only when the patient coughs or forces exhalation
physician assessment of complete lung inflation by absence of signs of pneumothorax in chest x ray done to the patient during hospital stay
no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung
no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung
no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung
no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung
no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03830645
Brief Title
PRP in 2ry Spontaneous Pneumothorax
Official Title
Platelet Rich Plasma in Secondary Spontaneous Pneumothorax
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
November 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
secondary spontaneous pneumothorax patients will be enrolled ,all of them will receive PRP with different doses and schedules
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumothorax Spontaneous Secondary
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Platelet rich plasma group
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Platelet Rich Plasma
Intervention Description
Application of platelet rich plasma through the intercostal tube into the pleural space
Primary Outcome Measure Information:
Title
Air leak assessment by Cerfolio classification of the air leak by single observer
Description
Continuous:Air leak is Present throughout the respiratory cycle Inspiratory : Present during the inspiration phase of the respiratory cycle. Expiratory: Present only during the expiratory phase of the respiratory cycle Forced expiration: Present only when the patient coughs or forces exhalation
Time Frame
within 10 days after application of platelet rich plasma
Title
physician assessment of complete lung inflation by absence of signs of pneumothorax in chest x ray done to the patient during hospital stay
Description
no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
Time Frame
within 10 days after application of platelet rich plasma
Title
recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung
Description
no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
Time Frame
one month after removal of intercostal tube
Title
recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung
Description
no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
Time Frame
two months after removal of intercostal tube
Title
recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung
Description
no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
Time Frame
three months after removal of intercostal tube
Title
recurrence of pneumothorax by physician interpretation of Chest x ray done to the patient in follow up visit i.e detecting jet balck translucency or border of collapsed lung
Description
no Chest x ray signs of pneumothorax i.e no jet balck translucency or border of collapsed lung) by physician interpretation
Time Frame
six months after removal of intercostal tube
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
COPD patients developed spontanous pneumothorax and was managed with intercostal tube insertion
Exclusion Criteria:
refusal of participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmad Abbas, MD
Phone
201155355369
Email
amabbaas@zu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammed Walaa, MD
Phone
201002089696
Facility Information:
Facility Name
Zagazig University Faculty of medicine Chest Department
City
Zagazig
State/Province
Asharqia
ZIP/Postal Code
44519
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmad Abbas, MD
Phone
201155355369
Email
amabbaas@zu.edu.eg
12. IPD Sharing Statement
Learn more about this trial
PRP in 2ry Spontaneous Pneumothorax
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