Systematic Review of Antimicrobial Biomaterials for Medical Implants: Clinical Strategies for Reducing Device-Associated Infections

Abstract

<b>Background:</b> Device-associated infections remain major complications of medical implants, contributing to prolonged hospitalisation, revision surgery, morbidity, and increased healthcare burden. Biofilm formation provides the biological rationale for antimicrobial implant strategies, although clinical studies often assess downstream infection outcomes rather than direct biofilm measures.<br /> <b>Objectives:</b> This systematic review evaluated the clinical effectiveness, safety, and certainty of evidence for antimicrobial biomaterials and implant surface modification strategies in reducing device-associated infections, reinfection, microbial colonisation, and related complications among human implant recipients.<br /> <b>Methodology:</b> A systematic search of PubMed, ScienceDirect, and Dimensions was conducted for original human studies published between 2015 and 2025. Eligible studies included randomised trials and observational cohorts evaluating antimicrobial biomaterials against conventional, uncoated, or standard-care comparators. Data extraction covered implant type, antimicrobial coating, comparator, infection-related outcomes, adverse events, and follow-up duration. Quality appraisal was performed using RoB 2 and ROBINS-I, while certainty of evidence was assessed narratively. A structured narrative synthesis was conducted because of heterogeneity in implant types, interventions, indications, comparators, and outcome definitions.<br /> <b>Findings:</b> Twenty studies were included. DAC hydrogel coatings showed the most consistent association with reduced surgical site infection, periprosthetic joint infection, reinfection, and complications in selected orthopaedic settings. Silver- and iodine-coated implants showed promise in high-risk oncological reconstruction, while gentamicin-coated nails and calcium sulphate-based strategies appeared useful in trauma fixation and second-stage reimplantation. However, most studies were retrospective or non-randomised, several had serious risk of bias, and none directly quantified biofilm formation.<br /> <b>Conclusion:</b> Antimicrobial biomaterials may reduce infection risk in selected implant settings, especially orthopaedic applications, but broader conclusions require cautious interpretation and stronger prospective evidence.