Fast-resorbable antibiotic-loaded hydrogel coating to reduce post-surgical infection after internal osteosynthesis: a multicenter randomized controlled trial

Abstract

BackgroundInfection is one of the main reasons for failure of orthopedic implants. Antibacterial coatings may prevent bacterial adhesion and biofilm formation, according to various preclinical studies. The aim of the present study is to report the first clinical trial on an antibiotic-loaded fast-resorbable hydrogel coating (Defensive Antibacterial Coating, DAC®) to prevent surgical site infection, in patients undergoing internal osteosynthesis for closed fractures.Materials and methodsIn this multicenter randomized controlled prospective study, a total of 256 patients in five European orthopedic centers who were scheduled to receive osteosynthesis for a closed fracture, were randomly assigned to receive antibiotic-loaded DAC or to a control group (without coating). Pre- and postoperative assessment of laboratory tests, wound healing, clinical scores and X-rays were performed at fixed time intervals.ResultsOverall, 253 patients were available with a mean follow-up of 18.1 ± 4.5 months (range 12–30). On average, wound healing, clinical scores, laboratory tests and radiographic findings did not show any significant difference between the two groups. Six surgical site infections (4.6%) were observed in the control group compared to none in the treated group (P < 0.03). No local or systemic side-effects related to the DAC hydrogel product were observed and no detectable interference with bone healing was noted.ConclusionsThe use of a fast-resorbable antibiotic-loaded hydrogel implant coating provides a reduced rate of post-surgical site infections after internal osteosynthesis for closed fractures, without any detectable adverse event or side-effects.Level of evidence2.

High percentage of microbial colonization of osteosynthesis material in clinically unremarkable patients

“…The finding of a high colonization rate in implants of noninfected patients is of importance when considering the common understanding that colonization is a trigger for infection. The results of our study may also give rise to protect implants from colonization by procedures like antibiotic-loaded coating (Schmidmaier et al, 2006) or intraoperative gel application (Malizos et al, 2017).…”

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

“…Other studies have shown the effectiveness of ALH against relapses or reinfections by applying the product during the reimplantation with an ongoing PJI [22,23]. Finally, a multicenter randomized clinical trial demonstrated its preventive efficacy by applying the ALH on the internal fixation implants used in the treatment of closed fractures [24]. When compared to the control population, there were no increased side effects reported in any of the studies done on hydrogel, including this one.…”

“…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].…”

Local Antibacterial Implant Protection in Orthopedics and Trauma: What’s New?

“…At a mean follow-up of 18.1 months (sd 4.5), six SSIs (4.6%) were observed in the control group compared with none in the treated group (p<0.02). No local or systemic side effects related to DAC hydrogel coating were observed, and no detectable interference with bone healing was reported [61]. More recently, DAC hydrogel-coated cementless was tested safe for onestage exchange for infected prosthesis (Fig.…”