Infection and inflammatory reaction due to other cardiac and vascular devices, implants and grafts
Conditions
Interventions
This is an experimental, double-blind, applied, exploratory research with a quantitative analytical approach and a prospective longitudinal design. The participants of this study will be adults, regar
Sponsors
Centro Universitário Católico Salesiano Auxilium
Centro Universitário Católico Salesiano Auxilium
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Adults aged 18 or over; both genders; treated at the Santa Casa de Misericórdia Public Hospital, in the city of Araçatuba; planning for insertion and/or replacement of a Cardiac Pacemaker
Exclusion criteria
Exclusion criteria: Non-consent to participate in the study; known allergy to Gentamicin; patients on Hemodialysis or Peritoneal Dialysis; history of previous heart transplantation; previous infection in implantable cardiac devices; previous infection with another prosthetic device; endovascular infection, including Endocarditis in the last 12 months; physical, clinical or laboratory signs or symptoms consistent with active infection; including but not limited to Pneumonia; urinary tract infection; cellulitis or bacteremia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gentamicin applied to the subcutaneous pacemaker site is expected to reduce site infection, which is defined by the presence of clinical signs of inflammation restricted to the pulse generator site (erythema, heat, fluctuation, wound dehiscence, tissue fragility, or purulent drainage) associated or not with signs of systemic infection (presence of fever measured at > 37.6 ºC, chills, and sweating) in the 90-day follow-up period | — |
Secondary
| Measure | Time frame |
|---|---|
| It has no secondary outcome | — |
Countries
Brazil
Contacts
Public ContactBruna Oliveira
Centro Universitário Católico Salesiano Auxilium
Outcome results
None listed