MedTrace Logo

Efficacy, Safety and Re-occurrence of Pneumothorax and Hydro-pneumothorax With Talc and Pyodine Pleurodesis

NCT04130451 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2019-10-17

No results posted yet for this study

Summary

Abstract:

INTRODUCTION:

Pneumothorax and hydro-pneumothorax are the most common thoracic injuries and poses a risk of serious morbidity.To prevent the lung from collapsing in such condition, pleurodesis procedure is performed either with surgical pleurodesis,or chemical pleurodesis which adheres outside the lung to the inside chest cavity. The common chemicals that are used are bleomycin, tetracycline, minocycline, slurry of talc and povidoneiodine.

In developed countries, the most common chemical agent used is talc, tetracycline derivatives and bleomycin. However, its clinical results depend on the level of collapse of the lung on the affected side.Internationally, for spontaneous pneumothoraces, talc is the best chemical for pleurodesis procedure which is insufflation through thoracoscopy. However its safety is debateable especially in acute respiratory disease after its administrationwhich made it null and vide consequently. Secondly, in developing countries,medical grade talc availability and affordability remains a constraint. The other suitable chemical is Iodopovidone which is inexpensive and widely used as topical antiseptic in many countries. It also hasshown a safe and effective chemical agent for pleurodesis procedure.

OBJECTIVES:

To determine the efficacy, safety and reoccurrence rate of in pneumothorax and hydro-pneumothorax patients after procedure with talc and pyodine pleurodesis: A comparative study.

MATERIALS AND METHOD:

On the basis of inclusion criteria, the selected 104 patients will be grouped (talc and pyodine) through Non probability, purposive sampling method. In each group 52 willing participants will be included without considering the size of pneumothorax. Six readings of each individual participant will be taken (3 before procedure and 3 after procedure for each group) for pulse and respiratory rate, fever, and total counts of leukocyte. Pain will be assessed on analogue scale. The readings will be taken with 8 hours gap apart. Re-occurrence will be determined after 6 months period of the procedure along with complications if any. The results of both groups will be compared for Efficacy, Safety and Re-occurrence of Pneumothorax and Hydro-pneumothorax.

KEYWORDS:

Pyodine pleurodesis, Talc, hydro-pneumothorax, iodopovidone, pleural effusion, pneumothorax, malignant/prevention \& control; Pleurodesis/methods; Recurrence

Conditions

  • Secondary Pneumothorax

Interventions

DRUG

PYODINE AND TALC SLURRY

pyodine Povidone-iodine is a broad spectrum antiseptic for topical application in the treatment and prevention of wound infection. It may be used in first aid for minor cuts, grazes, burns, abrasions and blisters. TALC a white, grey, or pale green soft mineral with a greasy feel, occurring as translucent masses or laminae and consisting of hydrated magnesium silicate

Sponsors & Collaborators

  • Dow University of Health Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-25
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Pakistan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04130451 on ClinicalTrials.gov