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

Phase 4

Completed

• Conditions: Pleural Effusion; Empyema; Pleurisy
• Interventions: Other: saline; Drug: Cefazolin

• Registration Number: NCT02446782
• Lead Sponsor: Post Graduate Institute of Medical Education and Research, Chandigarh

Brief 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.

Detailed 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 Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-05-09
• Study First Submitted QC: 2015-05-13
• Study First Posted: 2015-05-18
• Primary Completion: 2016-04
• Study Completion: 2016-06
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-16
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
saline	saline	100 mL normal saline will be administered intravenously over a period of 10 minutes between 15 and 30 minutes before the incision. An intradermal test dose with normal saline will be administered to this group.
Cefazolin	Cefazolin	A single dose of intravenous cefazolin 2 gms will be administered over 10 minutes, dissolved in 100 mL of normal saline between 15 and 30 minutes before the incision. This will be preceded by an intradermal test dose to check for hypersensitivity to the drug. If hypersensitivity is present, the patient will be administered a single dose of intravenous Clindamycin 900 mg.

Primary Outcome Measures

Name	Time	Method
Efficacy as assessed by occurrence of wound infection or pleural space infection	2 months	(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.

Secondary Outcome Measures

Name	Time	Method
Safety as assessed by adverse effects	7 days	Adverse effects arising as a result of the antibiotic administered

Trial Locations

Locations (1)

PGIMER; 🇮🇳 Chandigarh, India