drugset / Trial / NCT04039126
Comparison of the Effectiveness of Povidone-Iodine Alone to Povidone-Iodine-Tetracycline Combination
Phase 1
Unknown
62 enrolled
University College Hospital, Ibadan
West African College of Surgeons · collab
RandomizedParallel-groupTriple-blindTreatment
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: 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.
Timeline
- Start
- 2019-06-20
- Primary completion
- 2020-12
- Completion
- 2021-03-31
Publications
- Background Psallidas I, Kalomenidis I, Porcel JM, Robinson BW, Stathopoulos GT. Malignant pleural effusion: from bench to bedside. Eur Respir Rev. 2016 Jun;25(140):189-98. doi: 10.1183/16000617.0019-2016.
- Background Antony VB, Loddenkemper R, Astoul P, Boutin C, Goldstraw P, Hott J, Rodriguez Panadero F, Sahn SA. Management of malignant pleural effusions. Eur Respir J. 2001 Aug;18(2):402-19. doi: 10.1183/09031936.01.00225601. No abstract available.
- Background Chernow B, Sahn SA. Carcinomatous involvement of the pleura: an analysis of 96 patients. Am J Med. 1977 Nov;63(5):695-702. doi: 10.1016/0002-9343(77)90154-1. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Povidone-Iodine | Other / unclassified | 10 % | Other |
| Subject | Povidone-Iodine | Other / unclassified | 20 ml | Other |
| Subject | Tetracycline | Unknown | 1 g | Other |