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Efficacy and Safety of Prophylactic Use of an Antibiotic for Medical Thoracoscopy — APT  

Pleural Effusion Clinical Trial

Official title:
A Study to Evaluate the Efficacy and Safety of a Single Dose of an Injectable Antibiotic for the Prophylaxis of Surgical Site and Pleural Space Infection After Medical Thoracoscopy

Clinical Trial Summary

This is a prospective study to assess the efficacy and safety of a single dose of cefazolin 2g IV for the prophylaxis of surgical site and pleural space infections in patients undergoing medical thoracoscopy.

Clinical Trial Description

This is a prospective randomized study to assess the efficacy and safety of a single dose of cefazolin 2g IV for the prophylaxis of surgical site and pleural space infections during medical thoracoscopy.

Consecutive patients who are planned to undergo a medical thoracoscopy (rigid or semirigid) will be enrolled in the study if they satisfy the inclusion and exclusion criteria. One hundred patients will be randomized in 1:1 ratio to receive either of the following: (a) A single dose of intravenous cefazolin 2 gms dissolved in 100 mL of normal saline administered over 10 minutes, between 15 and 30 minutes before the incision, OR (b) 100 mL normal saline administered intravenously over a period of 10 minutes between 15 and 30 minutes before the incision. Thoracoscopy will be performed in the bronchoscopy suite on a spontaneously breathing subject (fasting for 8 h) under conscious sedation (using midazolam, pentazocine, and tramadol) observing complete aseptic precautions. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02446782
Study type Interventional
Source Postgraduate Institute of Medical Education and Research
Contact
Status Completed
Phase Phase 4
Start date January 2015
Completion date June 2016
View Details
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