RecruitingPhase 2NCT06355115

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

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

Sponsor

University of Brawijaya

Enrollment

100 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

Pacemaker Complication

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.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria4

Adult patients, aged 18 to 100 years old, with indications for PPM (single or double chamber) installation.
The patient is scheduled to undergo PPM installation for the first time
The patient is willing to undergo routine follow-ups and visits
Patients who are medically stable and do not have any acute illnesses that could interfere with the study outcomes.

Exclusion Criteria14

Patients with fever before the Procedure
Skin disease
Patients on anticoagulants or receiving bridging heparin
Patients who used antibiotics 30 days before the PPM installation was carried out
Patients with end stage renal failure
Patients with uncontrolled Diabetes Mellitus
Patients with a history of infective endocarditis
Patients with a history of moderate to severe valvular heart disease
Patients with congenital heart disease
Patients with non-cardiac comorbid diseases whose life expectancy is < 1 year
Illness or physical disorder that causes the patient to be unable or limited to carry out physical activities
Patients with a history of autoimmune disease, and confirmed autoimmune disease
Patients on long-term steroid use
The patient refused follow-up