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A Comparative Study of the Safety and Efficacy of Face Talc Slurry and Iodopovidone for Pleurodesis

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ClinicalTrials.gov Identifier: NCT00430664
Recruitment Status : Unknown
Verified February 2007 by Postgraduate Institute of Medical Education and Research.
Recruitment status was:  Recruiting
First Posted : February 2, 2007
Last Update Posted : February 2, 2007
Sponsor:
Information provided by:
Postgraduate Institute of Medical Education and Research

Study Description
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Brief Summary:
Pleurodesis is a technique used to fuse the two layers of the lining over the lung. This is done to get rid of collections of fluid or air in this space. A common reason would be cancer of the underlying lung or elsewhere causing fluid to collect in the pleural space. In this situation it is a palliative procedure to free the patient from symptoms like breathlessness.

Condition or disease Intervention/treatment Phase
Malignant Pleural Effusions Recurrent Pleural Effusions Primary Spontaneous Pneumothorax Secondary Spontaneous Pneumothorax Procedure: Pleurodesis with either talc or iodopovidone Not Applicable

Detailed Description:
Pleurodesis is a technique used to fuse the two layers of the pleura. This is done to prevent reaccumulation of collections of fluid or air in this space. Common indications are malignant pleural effusions, recurrent pneumothorax and even benign effusions which are otherwise difficult to eradicate.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Study of the Safety and Efficacy of Face Talc Slurry and Iodopovidone for Pleurodesis
Study Start Date : January 2006
Study Completion Date : December 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Success
  2. Failure

Secondary Outcome Measures :
  1. Death
  2. Pain by VAS
  3. Time to Pleurodesis
  4. Others

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age over 12 years
  • Symptomatic recurrent pleural effusion
  • Pneumothorax needing pleurodesis

Exclusion Criteria:

  • Life expectancy <1 month
  • Unwilling to give consent
  • Empyema
  • ICTD drain output >150 ml/d
  • Presence of an airleak
Contacts and Locations
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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): NCT00430664


Locations
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India
PGIMER Recruiting
Chandigarh, India, 160 012
Contact: Abinash Paul, MD    91-9417745955    draspaul@yahoo.co.in   
Contact: Ritesh Agarwal, MD DM    91- 9815799226    ritesh@indiachest.org   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
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Principal Investigator: Dheeraj Gupta, MD, DM, FCCP Additional Professor, Dept of Pulmonary Medicine, PGIMER, Chandigarh, India
More Information
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ClinicalTrials.gov Identifier: NCT00430664     History of Changes
Other Study ID Numbers: 7134-PG-1Tg-05/5469-71
First Posted: February 2, 2007    Key Record Dates
Last Update Posted: February 2, 2007
Last Verified: February 2007
Keywords provided by Postgraduate Institute of Medical Education and Research:
pleurodesis
talc
iodopovidone
Additional relevant MeSH terms:
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Pleural Effusion, Malignant
Pleural Effusion
Pneumothorax
Pleural Diseases
Respiratory Tract Diseases
 Pleural Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms