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

February 1, 2007 updated by: Postgraduate Institute of Medical Education and Research
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Success
Failure

Secondary Outcome Measures

Outcome Measure
Death
Pain by VAS
Time to Pleurodesis
Others

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Postgraduate Institute of Medical Education and Research

Investigators

  • Principal Investigator: Dheeraj Gupta, MD, DM, FCCP, Additional Professor, Dept of Pulmonary Medicine, PGIMER, Chandigarh, India

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Study Completion

December 1, 2007

Study Registration Dates

First Submitted

February 1, 2007

First Submitted That Met QC Criteria

February 1, 2007

First Posted (Estimate)

February 2, 2007

Study Record Updates

Last Update Posted (Estimate)

February 2, 2007

Last Update Submitted That Met QC Criteria

February 1, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7134-PG-1Tg-05/5469-71

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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