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

 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.

 Methodology: 62 consenting but blinded patients with clinical features of MPE who are
 undergoing pleural drainage and have fulfilled the criteria for chemical pleurodesis will be
 grouped by block balanced randomization into two equal groups- A and B. All the patients in
 Group A (Test) will have pleurodesis done with a solution combining 1 gram of sterile
 Tetracycline powder with 20mls of 10% Povidone-iodinemixed with 10mls of 1% xylocaine (for
 local intrapleural anesthesia) and 30mls of sterile water for injection instilled through the
 chest tube into the pleural space, while allpatients in Group B (Active control) will have
 20mls of 10% Povidone-iodine mixed with 10mls of 1% xylocaine and 30mls of sterile water for
 injection. Drainage and radiographic parameters will be collected prior to chest tube removal
 and during outpatient follow-up to assess the effectiveness of pleurodesis in each group.

 Objectives: To determine if combining tetracycline with 10% Povidone-iodine increases its
 effectiveness in pleurodesis for MPE.

 Principal Exposure:Chemical pleurodesis with 10% Povidone-Iodine or combination of 10%
 Povidone-iodine-Tetracycline (1 gram).

 Outcome variables: The primary outcome variable is the success of the pleurodesis in
 controlling MPE at 1month and 3 months follow-up. Success of pleurodesis classified as been
 Complete pleurosesis or Failed pleurodesis. The secondary outcome variables are:
 post-procedure complications of pain, hypotension,fever and occurrence of empyema thoracis,
 duration of thoracostomy tube retention post-pleurodesis, need for repeat of the procedure
 Keywords: Malignant Pleural Effusion, Chemical Pleurodesis, 10% Povidone-iodine,
 Tetracycline, Effectiveness
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