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Comparison of the Effectiveness of Povidone-Iodine Alone to Povidone-Iodine-Tetracycline Combination for Chemical Pleurodesis in Malignant Pleural Effusion
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: Prospective Randomized Controlled Clinical Trial. Background: Malignant pleural effusion (MPE) is commonly encountered in clinical practice among patients with malignancy. In addition to its association with major morbidities, it also poses a high risk of recurrence following drainage. Chemical pleurodesis is often required to achieve pleural adhesion and obliteration of the pleural space to prevent such recurrence. Several agents are in common use for chemical pleurodesis with mixed effectiveness.
Details
| Lead sponsor | University College Hospital, Ibadan |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 62 |
| Start date | 2019-06-20 |
| Completion | 2021-03-31 |
Conditions
- Malignant Pleural Effusion
Interventions
- CHEMICAL PLEURODESIS WITH POVIDONE-IODINE-TETRACYCLINE COMBINATION
- CHEMICAL PLEURODESIS WITH POVIDONE-IODINE ALONE
Primary outcomes
- Success of pleurodesis — 1 AND 3 MONTH AFTER PLEURODESIS
classified as either a Complete Pleurodesis or Failed Pleurodesis. Complete pleurodesis defined as absence of pleural fluid re-accumulation on a chest radiograph at 1 and 3 months post-chemical pleurodesis, while Failed pleurodesis defined as pleural fluid re-accumulation requiring additional tube thoracostomy drainage before or at 1- 3 month follow up.
Countries
Nigeria