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

Post Graduate Institute of Medical Education and Research, Chandigarh100 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

100

Conditions

Pleural Effusion Pleurisy Empyema

Interventions

CefazolinDRUG

Cefazolin 2 gm administered in 100 mL normal saline (after skin sensitivity testing) 15-30 minutes before the start of the procedure. Clindamycin 900 mg to be administered if sensitivity detected to cefazolin.

salineOTHER

100 mL normal saline 15-30 minutes before the start of the procedure

Eligibility

Sex: ALLMin age: 12 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥12 years 2. Medical thoracoscopy being performed for a pleural effusion for any of the three indications: diagnosis, pleurodesis, or adhesiolysis Exclusion Criteria: 1. Age ≥80 years 2. Pao2/FIO2\< 300; 3. Hemodynamic instability 4. Myocardial infarction or unstable angina in the last 6 wk 5. Lack of pleural space due to adhesions 6. Uncorrected coagulopathy 7. Failure to provide informed consent 8. Patients already taking any antibiotic due to any reason

Locations (1)

PGIMER

Chandigarh, Chandigarh, India

Outcomes

Primary Outcomes

Efficacy as assessed by occurrence of wound infection or pleural space infection

(a) Occurrence of wound infection as indicated by development of a purulent discharge from the surgical site or (b) pleural space infection as indicated by development of purulence, fall in sugar levels or gram's stain or culture positivity in the pleural fluid drained by the chest tube on the side of the procedure.

Time frame: 2 months

Secondary Outcomes

Safety as assessed by adverse effects

Adverse effects arising as a result of the antibiotic administered

Time frame: 7 days

Data from ClinicalTrials.gov

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