Does an Antibiotic-Loaded Hydrogel Coating Reduce Early Post-Surgical Infection After Joint Arthroplasty?

Abstract

Background: Infection remains among the main reasons for joint prosthesis failure. Preclinical reports have suggested that antibacterial coatings of implants may prevent bacterial adhesion and biofilm formation. This study presents the results of the first clinical trial on an antibiotic-loaded fast-resorbable hydrogel coating (Defensive Antibacterial Coating, DAC®) in patients undergoing hip or knee prosthesis.Methods: In this multicenter, randomized prospective study, a total of 380 patients, scheduled to undergo primary (n=270) or revision (n=110) total hip (N=298) or knee (N=82) joint replacement with a cementless or a hybrid implant, were randomly assigned, in six European orthopedic centers, to receive an implant either with the antibiotic-loaded DAC coating (treatment group) or without coating (control group). Pre- and postoperative assessment of clinical scores, wound healing, laboratory tests, and x-ray exams were performed at fixed time intervals.Results: Overall, 373 patients were available at a mean follow-up of 14.5 ± 5.5 months (range 6 to 24). On average, wound healing, laboratory and radiographic findings showed no significant difference between the two groups. Eleven early surgical site infections were observed in the control group and only one in the treatment group (6% vs. 0.6%; p=0.003). No local or systemic side effects related to the DAC hydrogel coating were observed, and no detectable interference with implant osteointegration was noted.Conclusions: The use of a fast-resorbable, antibiotic-loaded hydrogel implant coating can reduce the rate of early surgical site infections, without any detectable adverse events or side effects after hip or knee joint replacement with a cementless or hybrid implant.

Fast-resorbable antibiotic-loaded hydrogel coating to reduce postsurgical infection after internal osteosynthesis: A multicenter randomized controlled trial

“…Moreover, no changes in organ-specific serum markers or systemic unwanted effects were recorded. This finding is in line with previous data from in vivo and clinical studies [26,27,34]. The high biocompatibility of its basic constituents and the short time (\3 days) needed for complete hydrogel resorption [22,25] make the possible occurrence of longer term side-effects unlikely.…”

Hyaluronic-Based Antibacterial Hydrogel Coating for Implantable Biomaterials in Orthopedics and Trauma: From Basic Research to Clinical Applications

“…In a first trial, a total of 380 patients, scheduled to undergo primary (n = 270) or revision (n = 110) total hip (N = 298) or knee (N = 82) joint replacement with cementless or hybrid (partially cemented) implants were included [59,60]. The patients were randomly assigned, in six European orthopedic centers, to receive an implant either with the DAC ® coating, intraoperatively loaded with antibiotics (treatment group), or without the coating (control group).…”

Antibiotic-Loaded Hydrogel Coating to Reduce Early Postsurgical Infections in Aseptic Hip Revision Surgery: A Retrospective, Matched Case-Control Study

“…In particular, out of 52 revision prostheses treated without the hydrogel, they encountered 4 infections (13.4%), while the outcome in the treatment group subjects was 0 out of 54. However, it should be noted that, 48 (92.3%) patients in the control group and 51 (94.4%) in the treatment group were patients who underwent the second surgery of a TSE for periprosthetic infection [21].…”

“…The need to have a valid local antibiotic-prophylaxis in cementless prostheses has stimulated the research towards the development of alternative tools, such as ALH. Studies on the local application of hydrogel in prosthetic surgery seem to support the use of this type of coating [21][22][23][24].…”