Rigi10™ Malleable Penile Prosthesis
Also Known As
Antibiotic-coated, antibiotic-eluting, antibiotic-loaded, local antibiotic delivery, antibiotic beads, antimicrobial impregnation.
Definition
Antibiotic impregnation refers to the process of incorporating or coating medical devices, materials, or localized drug delivery systems with antibiotics to prevent or treat infections, particularly at a surgical site or in relation to an implanted device. This technique aims to deliver high concentrations of antimicrobial agents directly to the target area, thereby minimizing systemic exposure and associated side effects while maximizing local efficacy against pathogenic microorganisms.¹² The mechanism often involves the sustained release of antibiotics from the impregnated material over a period, providing prolonged protection against bacterial colonization and biofilm formation. Examples include antibiotic-eluting bioenvelopes for cardiovascular implantable electronic devices (CIEDs) which release drugs like rifampin and minocycline from polymer discs,¹ or antibiotic-impregnated beads (e.g., made of polymethyl methacrylate or calcium sulfate) used in orthopedic and vascular surgery to combat surgical site infections.² The primary purpose is to reduce the incidence of device-related infections and surgical site infections, which can lead to significant morbidity, mortality, and healthcare costs.¹²
Clinical Context
Antibiotic impregnation is utilized in various clinical scenarios where the risk of infection is high, particularly in procedures involving the implantation of foreign materials or in complex surgical sites. For instance, in cardiovascular surgery, antibiotic-eluting envelopes are used with CIEDs to prevent pocket infections, which can occur in up to 4% of patients.¹ These envelopes release antibiotics locally to eradicate bacteria introduced during implantation, such as Staphylococcus aureus and S. epidermidis, thereby improving patient outcomes and reducing the need for device explantation.¹
In orthopedic and trauma surgery, antibiotic-impregnated beads are commonly employed for the treatment and prevention of osteomyelitis and prosthetic joint infections.² These beads deliver high concentrations of antibiotics directly to the bone or joint space, which is often poorly vascularized, making systemic antibiotic therapy less effective.² They are also used in complex wound management and in high-risk vascular surgery cases, such as for the treatment of graft infections or prevention of surgical site infections in patients with comorbidities like diabetes.² While evidence suggests positive outcomes in many cases, such as reported freedom from recurrence rates of 41%-87.5% for graft infections treated with antibiotic beads, the quality of evidence for some applications still requires more robust, high-level studies.² Patient selection criteria often include those at high risk for infection due to previous infections, comorbidities, complex or prolonged surgical procedures, or the presence of prosthetic materials. The surgical application involves placing the antibiotic-impregnated material (e.g., envelope, beads, cement) at the target site during the primary or revision surgery. Expected outcomes include a reduction in infection rates, improved wound healing, and preservation of implant function, though success rates can vary depending on the specific application, patient factors, and the type of antibiotic impregnation used.¹²