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 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.

Study Overview

• Status: Unknown
• Conditions: Malignant Pleural Effusion
• Intervention / Treatment: Drug: CHEMICAL PLEURODESIS WITH POVIDONE-IODINE-TETRACYCLINE COMBINATION; Drug: CHEMICAL PLEURODESIS WITH POVIDONE-IODINE ALONE

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Phase 1

Contacts and Locations

Study Locations

• Nigeria
  • Oyo
    • Ibadan, Oyo, Nigeria, 200212
      • Recruiting
      • University College Hospital,
      • Contact: Jibril Khalil, MBBS; Phone Number: +2348036602929; Email: jibril.khalil@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PATIENTS WITH MALIGNANT PLEURAL EFFUSION; PARTICIPANTS WITH MALIGNANT PLEURAL EFFUSIONS REQUIRING PLEURODESIS, COMBINATION OD POVIDONE IODOONE-TETRCYCLINE TO BE USED.	Drug: CHEMICAL PLEURODESIS WITH POVIDONE-IODINE-TETRACYCLINE COMBINATION; Pleurodesis is the obliteration of the pleural cavity by inducing adhesions of the visceral and parietal pleural layers, mostly used in patients with pleural effusions, pneumothorax (18). The use of pleurodesis to induce pleural symphysis between the pleural layers dates backs to the beginning of the 20th century by Benthune(19) and has continued to evolve with different Thoracic surgeons and researchers still looking for the ideal pleurodesis agent.; Other Names: PLEURODESIS; Drug: CHEMICAL PLEURODESIS WITH POVIDONE-IODINE ALONE; 20mls of 10% povidone-iodine (Wosan Solution Povidone-Iodine Usp 10%, Jawa International Limited) is mixed with 10mls of 1% xylocaine and 30mls of water for injection added to the mixture, making also a total volume of 60mls of the the single pleurodesis agents alone, which will be instilled into the pleural space via the closed thoracotomy tube.; Other Names: PLEURODESE
Active Comparator: PATEINT WITH MALIGANT PLEURAL EFFUSION REQUIRNG PLEURODESIS; TO USE POVIDONE IODINE ALONE IN THIS GROUP	Drug: CHEMICAL PLEURODESIS WITH POVIDONE-IODINE ALONE; 20mls of 10% povidone-iodine (Wosan Solution Povidone-Iodine Usp 10%, Jawa International Limited) is mixed with 10mls of 1% xylocaine and 30mls of water for injection added to the mixture, making also a total volume of 60mls of the the single pleurodesis agents alone, which will be instilled into the pleural space via the closed thoracotomy tube.; Other Names: PLEURODESE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of 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.	1 AND 3 MONTH AFTER PLEURODESIS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Effects from the chemical pleurodesis agent used	Adverse effects which are Post-procedure Pain, Hypotension, Fever and development of Empyema Thoracis following pleurodesis.	immediate post procedure( 30minutes and 1 hour)

Collaborators and Investigators

• Sponsor: University College Hospital, Ibadan
• Collaborators: West African College of Surgeons
• Investigators: Study Chair: catherine Falade, Prof., institute for advanced medical research and training, UI, IBADAN

Publications and helpful links

General Publications

• 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. Erratum In: Eur Respir Rev. 2016 Sep;25(141):360. Eur Respir Rev. 2016 Sep;25(141):360.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2019
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): March 31, 2021

Study Registration Dates

• First Submitted: July 27, 2019
• First Submitted That Met QC Criteria: July 27, 2019
• First Posted (Actual): July 31, 2019

Study Record Updates

• Last Update Posted (Actual): November 5, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: MALIGNANT PLEURAL EFFUSSION
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Pleural Effusion, Malignant; Pleural Effusion; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Enzyme Inhibitors; Trace Elements; Micronutrients; Anti-Bacterial Agents; Protein Synthesis Inhibitors; Plasma Substitutes; Blood Substitutes; Iodine; Cadexomer iodine; Povidone-Iodine; Povidone; Tetracycline
• Other Study ID Numbers: UI/EC/19/0177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: proforma of the study, with theinformation gathered during the study.
• IPD Sharing Time Frame: as the study is being conducted
• IPD Sharing Access Criteria: via email
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No