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Trial record 12 of 215 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

Tracking Information
First Submitted Date  ICMJE July 27, 2019
First Posted Date  ICMJE July 31, 2019
Last Update Posted Date July 31, 2019
Actual Study Start Date  ICMJE June 20, 2019
Estimated Primary Completion Date December 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the Effectiveness of Povidone-Iodine Alone to Povidone-Iodine-Tetracycline Combination
Official Title  ICMJE Comparison of the Effectiveness of Povidone-Iodine Alone to Povidone-Iodine-Tetracycline Combination for Chemical Pleurodesis in Malignant Pleural Effusion
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description:
DOUBLE BLINDED, PARTIPANT ASIIGNED USING WINPEPI
Primary Purpose: Treatment
Condition  ICMJE Malignant Pleural Effusion
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: PATIENTS WITH MALIGNANT PLEURAL EFFUSION
    PARTICIPANTS WITH MALIGNANT PLEURAL EFFUSIONS REQUIRING PLEURODESIS, COMBINATION OD POVIDONE IODOONE-TETRCYCLINE TO BE USED.
    Interventions:
    • Drug: CHEMICAL PLEURODESIS WITH POVIDONE-IODINE-TETRACYCLINE COMBINATION
    • Drug: CHEMICAL PLEURODESIS WITH POVIDONE-IODINE ALONE
  • Active Comparator: PATEINT WITH MALIGANT PLEURAL EFFUSION REQUIRNG PLEURODESIS
    TO USE POVIDONE IODINE ALONE IN THIS GROUP
    Intervention: Drug: CHEMICAL PLEURODESIS WITH POVIDONE-IODINE ALONE
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 27, 2019)
62
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 19, 2020
Estimated Primary Completion Date December 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jibril Khalil, MMBS +2348036602929 jibril.khalil@gmail.com
Contact: MUDASSIRU SALAMI, MRCS +2348023904206 drmudathirsalami@yahoo.com
Listed Location Countries  ICMJE Nigeria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04039126
Other Study ID Numbers  ICMJE UI/EC/19/0177
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: proforma of the study, with theinformation gathered during the study.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: as the study is being conducted
Access Criteria: via email
Responsible Party Dr. Jibril Khalil, University College Hospital, Ibadan
Study Sponsor  ICMJE University College Hospital, Ibadan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: catherine Falade, Prof. institute for advanced medical research and training, UI, IBADAN
PRS Account University College Hospital, Ibadan
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP