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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Postgraduate Institute of Medical Education and Research.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT00430664
First received: February 1, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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 Intervention
Malignant Pleural Effusions
Recurrent Pleural Effusions
Primary Spontaneous Pneumothorax
Secondary Spontaneous Pneumothorax
Procedure: Pleurodesis with either talc or iodopovidone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparative Study of the Safety and Efficacy of Face Talc Slurry and Iodopovidone for Pleurodesis

Resource links provided by NLM:


Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Success
  • Failure

Secondary Outcome Measures:
  • Death
  • Pain by VAS
  • Time to Pleurodesis
  • Others

Estimated Enrollment: 100
Study Start Date: January 2006
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430664

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

No publications provided

ClinicalTrials.gov Identifier: NCT00430664     History of Changes
Other Study ID Numbers: 7134-PG-1Tg-05/5469-71
Study First Received: February 1, 2007
Last Updated: February 1, 2007
Health Authority: India: Institute Ethics Comittee, PGIMER Chandigarh

Keywords provided by Postgraduate Institute of Medical Education and Research:
pleurodesis
talc
iodopovidone

Additional relevant MeSH terms:
Pleural Effusion
Pleural Effusion, Malignant
Pneumothorax
Neoplasms
Neoplasms by Site
Pleural Diseases
Pleural Neoplasms
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 22, 2014