PRP in 2ry Spontaneous Pneumothorax

Platelet Rich Plasma in Secondary Spontaneous Pneumothorax

secondary spontaneous pneumothorax patients will be enrolled ,all of them will receive PRP with different doses and schedules

Study Overview

• Status: Unknown
• Conditions: Pneumothorax Spontaneous Secondary
• Intervention / Treatment: Biological: Platelet Rich Plasma

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Asharqia
    • Zagazig, Asharqia, Egypt, 44519
      • Recruiting
      • Zagazig University Faculty of medicine Chest Department
      • Contact: Ahmad Abbas, MD; Phone Number: 201155355369; Email: amabbaas@zu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• COPD patients developed spontanous pneumothorax and was managed with intercostal tube insertion

Exclusion Criteria:

• refusal of participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Platelet rich plasma group	Biological: Platelet Rich Plasma; Application of platelet rich plasma through the intercostal tube into the pleural space

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	within 10 days after application of platelet rich plasma
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	within 10 days after application of platelet rich plasma
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	one month after removal of intercostal tube
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	two months after removal of intercostal tube
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	three months after removal of intercostal tube
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	six months after removal of intercostal tube

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2018
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: January 27, 2019
• First Submitted That Met QC Criteria: February 1, 2019
• First Posted (Actual): February 5, 2019

Study Record Updates

• Last Update Posted (Actual): June 30, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Pleural Diseases; Neoplastic Processes; Pneumothorax; Neoplasm Metastasis
• Other Study ID Numbers: ZU-IRB#4931-4-11-2018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No