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

NCT ID: NCT00430664

Last Updated: 2007-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Malignant Pleural Effusions Recurrent Pleural Effusions Primary Spontaneous Pneumothorax Secondary Spontaneous Pneumothorax

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Pleurodesis with either talc or iodopovidone

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Principal Investigators

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Dheeraj Gupta, MD, DM, FCCP

Role: PRINCIPAL_INVESTIGATOR

Additional Professor, Dept of Pulmonary Medicine, PGIMER, Chandigarh, India

Locations

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PGIMER

Chandigarh, , India

Site Status RECRUITING

Countries

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India

Facility Contacts

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Abinash Paul, MD

Role: primary

91-9417745955

Ritesh Agarwal, MD DM

Role: backup

91- 9815799226

Other Identifiers

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7134-PG-1Tg-05/5469-71

Identifier Type: -

Identifier Source: org_study_id

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