Overview

Comparison of the Effectiveness of Povidone-Iodine Alone to Povidone-Iodine-Tetracycline Combination

Status:
Recruiting
Trial end date:
2021-03-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University College Hospital, Ibadan
Collaborator:
West African College of Surgeons
Treatments:
Cadexomer iodine
Iodine
Povidone
Povidone-Iodine
Tetracycline
Criteria
Inclusion Criteria:

- • 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 Criteria:

- • 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