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RECRUITING
NCT06355115
PHASE2

Prophylactic Antibiotics Duration Towards Healing and Risk of Infection in Permanent Pacemaker (PPM) Installation

Sponsor: University of Brawijaya

View on ClinicalTrials.gov

Summary

The insertion of a permanent pacemaker (PPM) is frequently a life-saving procedure. However, the implantation process could sometimes lead to a rare but serious infection. Therefore, administering prophylactic antibiotics to prevent infections before they occur, is a useful strategy to lower the risk of such infections. Nonetheless, the optimal duration of prophylactic antibiotics for PPM remains uncertain. Individual study results are ambiguous and debatable due to the fact that each center has its own policy governing the regimen for prophylactic antibiotic use. Accordingly, the goal of this clinical trial is to assess and compare the effectiveness of two types of widely used prophylactic antibiotic durations in relation to the risk of infections following PPM implantations. The main questions it aims to answer are: 1. What is the efficacy of different durations of prophylactic antibiotics (single dosage vs 3-day dosage) in preventing infective complications following PPM implantations? 2. What factors may influence the optimum use of prophylactic antibiotics for individual patients undergoing PPM implantation to minimize the risk of infective complications? Researchers will compare a single dosage vs a 3-day dosage of prophylactic antibiotics following the PPM implantation procedure to see the risk of device-related infections. Participants will: * Be given a single-dose or 3-days dose of antibiotic regarding the PPM installations. * Visit the clinic for follow-ups and tests.

Official title: Comparison Effect Between a Single Dose Prophylaxis Antibiotics Given One Day and Three Days Towards Healing and Risk of Infection in Permanent Pacemaker (PPM) Installation: a Preliminary Study

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-09-01

Completion Date

2024-09-01

Last Updated

2024-04-09

Healthy Volunteers

No

Interventions

DRUG

Cefazolin 1000 MG Injection

Cefazolin 1000 mg given intravenously

Locations (1)

RSUD Dr. Saiful Anwar

Malang, East Java, Indonesia