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

Primary Spontaneous Pneumothorax Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00430664
• Other study ID #: 7134-PG-1Tg-05/5469-71
• Status: Recruiting
• Phase: N/A
• First received: February 1, 2007
• Last updated: February 1, 2007
• Start date: January 2006
• Est. completion date: December 2007

Study information

• Verified date: February 2007
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institute Ethics Comittee, PGIMER Chandigarh
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Pleural Effusions
• Pleural Effusion
• Pleural Effusion, Malignant
• Pneumothorax
• Primary Spontaneous Pneumothorax
• Recurrent Pleural Effusions
• Secondary Spontaneous Pneumothorax

Intervention

Procedure:
• Pleurodesis with either talc or iodopovidone

Locations

Country	Name	City	State
India	PGIMER	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success
Primary	Failure
Secondary	Death
Secondary	Pain by VAS
Secondary	Time to Pleurodesis
Secondary	Others