Loading clinical trials...
Loading clinical trials...
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
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.
The insertion of a permanent pacemaker (PPM) is a critical intervention often performed to manage various cardiac rhythm disorders, thereby enhancing patient survival and quality of life. However, the procedure carries a risk of introducing infections, which, although infrequent, can lead to severe complications. Prophylactic administration of antibiotics has been recognized as an effective measure to mitigate this risk by preventing the onset of infections prior to their occurrence. Despite the widespread acceptance of this practice, the optimal duration of antibiotic prophylaxis for PPM implantation remains a subject of debate. Variability in clinical protocols across different healthcare centers further complicates the establishment of a standardized approach. This clinical trial is designed to address this gap by evaluating and comparing the efficacy of two commonly employed prophylactic antibiotic regimens - a single dose versus a three-day course - in reducing the incidence of infectious complications following PPM implantations. The study aims to address the following research questions: 1. What is the comparative effectiveness of a single dose versus a three-day course of prophylactic antibiotics in preventing infectious complications after PPM implantation? 2. What patient-specific or procedural factors might influence the optimal choice and duration of prophylactic antibiotic therapy in the context of PPM implantation? To achieve these objectives, the trial will enroll patients scheduled for PPM implantation and randomly assign them to receive either a single dose or a three-day course of antibiotics. The choice of antibiotic will be based on our institutional guidelines, i.e. 1 gram of intravenous Cefazolin (first-generation cephalosporins), and by considering the patient's allergy history. The primary outcome will be the occurrence of device-related infections within a specified follow-up period, assessed through clinical examinations, laboratory tests, and imaging studies. Participants will be required to attend follow-up visits at designated intervals post-implantation for assessment of any signs of infection, wound healing, and device function. Adherence to the antibiotic regimen and any adverse reactions will also be monitored. By systematically comparing the outcomes of the two antibiotic regimens, this study aims to provide evidence-based guidance for the optimization of prophylactic antibiotic use in PPM implantations, thereby enhancing patient safety and treatment efficacy.
Age
18 - 100 years
Sex
ALL
Healthy Volunteers
No
RSUD Dr. Saiful Anwar
Malang, East Java, Indonesia
Start Date
September 1, 2023
Primary Completion Date
September 1, 2024
Completion Date
September 1, 2024
Last Updated
April 9, 2024
100
ESTIMATED participants
Cefazolin 1000 MG Injection
DRUG
Lead Sponsor
University of Brawijaya
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions