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Trial record 16 of 150 for:    tetracycline

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

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ClinicalTrials.gov Identifier: NCT04039126
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Jibril Khalil, University College Hospital, Ibadan

Brief 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.


Condition or disease Intervention/treatment Phase
Malignant Pleural Effusion Drug: CHEMICAL PLEURODESIS WITH POVIDONE-IODINE-TETRACYCLINE COMBINATION Drug: CHEMICAL PLEURODESIS WITH POVIDONE-IODINE ALONE Phase 1

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


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: DOUBLE BLINDED, PARTIPANT ASIIGNED USING WINPEPI
Primary Purpose: Treatment
Official Title: Comparison of the Effectiveness of Povidone-Iodine Alone to Povidone-Iodine-Tetracycline Combination for Chemical Pleurodesis in Malignant Pleural Effusion
Actual Study Start Date : June 20, 2019
Estimated Primary Completion Date : December 19, 2019
Estimated Study Completion Date : June 19, 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: PLEURODESE




Primary Outcome Measures :
  1. Success of pleurodesis [ Time Frame: 1 AND 3 MONTH AFTER 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.


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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039126


Contacts
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Contact: Jibril Khalil, MMBS +2348036602929 jibril.khalil@gmail.com
Contact: MUDASSIRU SALAMI, MRCS +2348023904206 drmudathirsalami@yahoo.com

Locations
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Nigeria
University College Hospital, Recruiting
Ibadan, Oyo, Nigeria, 200212
Contact: Jibril Khalil, MBBS    +2348036602929    jibril.khalil@gmail.com   
Sponsors and Collaborators
University College Hospital, Ibadan
Investigators
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Study Chair: catherine Falade, Prof. institute for advanced medical research and training, UI, IBADAN

Publications:
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Responsible Party: Dr. Jibril Khalil, Dr, University College Hospital, Ibadan
ClinicalTrials.gov Identifier: NCT04039126     History of Changes
Other Study ID Numbers: UI/EC/19/0177
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: proforma of the study, with theinformation gathered during the study.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: as the study is being conducted
Access Criteria: via email

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Jibril Khalil, University College Hospital, Ibadan:
MALIGNANT PLEURAL EFFUSSION
Additional relevant MeSH terms:
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Tetracycline
Pleural Effusion, Malignant
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Iodine
Cadexomer iodine
Povidone-Iodine
Povidone
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Plasma Substitutes
Blood Substitutes
Anti-Bacterial Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action