Status:
UNKNOWN
Comparison of the Effectiveness of Povidone-Iodine Alone to Povidone-Iodine-Tetracycline Combination
Lead Sponsor:
University College Hospital, Ibadan
Collaborating Sponsors:
West African College of Surgeons
Conditions:
Malignant Pleural Effusion
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Title of study: Comparison of the Effectiveness of Povidone-Iodine alone to Povidone-Iodine--Tetracycline Combination for Chemical Pleurodesis in Malignant Pleural Effusion. Research design: Prospect...
Detailed Description
STRUCTURED SUMMARY Title of study: Comparison of the Effectiveness of Povidone-Iodine alone to Povidone-Iodine--Tetracycline Combination for Chemical Pleurodesis in Malignant Pleural Effusion. Resear...
Eligibility Criteria
Inclusion
- • All adult patients aged between18- 70 years presenting with pleural effusion in association with a malignant disease.
- Patients with documented malignant pleural effusion ( i.e positive pleural fluid for malignant cells on pleural fluid cytology and/or positive pleural biopsy for malignant tissue).
- Reaccumulation of an effusion after drainage or patients presenting with symptoms related to pleural fluid re-accumulation such as dyspnea, cough and chest pain.
- Patient with full lung re-expansion after thoracostomy tube insertion and drainage of effusion.
Exclusion
- • Patients with known hypersensitivity either to Povidone-iodine and/or Tetracycline
- Failure to achieve full lung re-expansion following drainage of the effusion within 48hrs
- Locoregional radiotherapy to the effusion side.
- Loculated pleural effusion
- Refusal to participate in the study
Key Trial Info
Start Date :
June 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2021
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04039126
Start Date
June 20 2019
End Date
March 31 2021
Last Update
November 5 2020
Active Locations (1)
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1
University College Hospital,
Ibadan, Oyo State, Nigeria, 200212