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

University College Hospital, Ibadan

Status and phase: Unknown; Phase 1

Conditions: Malignant Pleural Effusion

Treatments: Drug: CHEMICAL PLEURODESIS WITH POVIDONE-IODINE-TETRACYCLINE COMBINATION; Drug: CHEMICAL PLEURODESIS WITH POVIDONE-IODINE ALONE

Study type: Interventional

Funder types: Other

Identifiers

NCT04039126

UI/EC/19/0177

Details and patient eligibility

About

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.

Full 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.

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

Enrollment: 62 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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62 participants in 2 patient groups

PATIENTS WITH MALIGNANT PLEURAL EFFUSION

Experimental group

Description:

PARTICIPANTS WITH MALIGNANT PLEURAL EFFUSIONS REQUIRING PLEURODESIS, COMBINATION OD POVIDONE IODOONE-TETRCYCLINE TO BE USED.

Treatment:

Drug: CHEMICAL PLEURODESIS WITH POVIDONE-IODINE ALONE

Drug: CHEMICAL PLEURODESIS WITH POVIDONE-IODINE-TETRACYCLINE COMBINATION

PATEINT WITH MALIGANT PLEURAL EFFUSION REQUIRNG PLEURODESIS

Active Comparator group

Description:

TO USE POVIDONE IODINE ALONE IN THIS GROUP

Treatment:

Drug: CHEMICAL PLEURODESIS WITH POVIDONE-IODINE ALONE