Antibacterial hydrogel implant coating may be safe for wrist, ankle osteosynthesis

The use of an antibacterial hydrogel coating on implants used to treat closed wrist or ankle fractures may effectively reduce infection rates and offer similar results compared to uncoated implants.

The defensive antibacterial coating (DAC) hydrogel product (Novagenit; Trento, Italy) studied effectively reduced infection rates in patients receiving the implants after their procedures, Nicola Logoluso, MD, told Orthopaedics Today Europe.

The study is among the best papers selected to be presented at this month’s EFORT Congress in Prague.

Nicola Logoluso, MD
Nicola Logoluso

“Clinical application of the DAC hydrogel coating ranges from cementless joint prostheses to internal osteosynthesis. Our data show that, on average, wound healing, clinical scores, laboratory tests and radiographic findings did not show any significant difference between DAC-treated vs. control, while two patients in the control group developed a surgical site infection within 90 days from surgery compared to none in the treated group,” Logoluso said.

DAC may reduce infection

The prospective, randomized controlled study included 70 patients who underwent internal osteosynthesis for closed wrist or ankle fractures. Patients were randomized to either a surgical group receiving a DAC implant or a group that received a typical uncoated implant. Patients underwent preoperative and postoperative assessments of laboratory tests, SF-12 clinical scores and wound healing scores. In addition, radiographs were taken throughout the study so those outcomes could also be compared.

Sara Scarponi, MD
Sara Scarponi

At 6 months mean follow-up, there was no clinically significant difference between the groups for laboratory tests or the SF-12 and wound healing scores. There were no surgical site infections for patients with the DAC-coated implant, but two patients in the control group developed infections, according to Logoluso.

Additional testing needed

Sara Scarponi, MD, another investigator, told Orthopaedics Today Europe additional studies are needed to confirm the efficacy of the coating in a clinical setting to see if it effectively prevents implant-related infection. This concept was previously successfully tested in animal models.

“Although these are preliminary data, this study shows a novel, fast-resorbable antibacterial hydrogel coating can be safely used in patients undergoing internal osteosynthesis for closed fractures and cementless joint prosthesis without local or systemic side effects and no radiological signs of interference with bone healing,” Scarponi said. – by Robert Linnehan

Disclosures: Logoluso and Scarponi report the project was funded by a grant from the European Community, “Implant Disposable Antibacterial Coating (I.D.A.C.): A Novel Approach to Implant-Related Infections,” 7th Framework Programme on Research Technological Development and Demonstration, grant no. 277988.

The use of an antibacterial hydrogel coating on implants used to treat closed wrist or ankle fractures may effectively reduce infection rates and offer similar results compared to uncoated implants.

The defensive antibacterial coating (DAC) hydrogel product (Novagenit; Trento, Italy) studied effectively reduced infection rates in patients receiving the implants after their procedures, Nicola Logoluso, MD, told Orthopaedics Today Europe.

The study is among the best papers selected to be presented at this month’s EFORT Congress in Prague.

Nicola Logoluso, MD
Nicola Logoluso

“Clinical application of the DAC hydrogel coating ranges from cementless joint prostheses to internal osteosynthesis. Our data show that, on average, wound healing, clinical scores, laboratory tests and radiographic findings did not show any significant difference between DAC-treated vs. control, while two patients in the control group developed a surgical site infection within 90 days from surgery compared to none in the treated group,” Logoluso said.

DAC may reduce infection

The prospective, randomized controlled study included 70 patients who underwent internal osteosynthesis for closed wrist or ankle fractures. Patients were randomized to either a surgical group receiving a DAC implant or a group that received a typical uncoated implant. Patients underwent preoperative and postoperative assessments of laboratory tests, SF-12 clinical scores and wound healing scores. In addition, radiographs were taken throughout the study so those outcomes could also be compared.

Sara Scarponi, MD
Sara Scarponi

At 6 months mean follow-up, there was no clinically significant difference between the groups for laboratory tests or the SF-12 and wound healing scores. There were no surgical site infections for patients with the DAC-coated implant, but two patients in the control group developed infections, according to Logoluso.

Additional testing needed

Sara Scarponi, MD, another investigator, told Orthopaedics Today Europe additional studies are needed to confirm the efficacy of the coating in a clinical setting to see if it effectively prevents implant-related infection. This concept was previously successfully tested in animal models.

“Although these are preliminary data, this study shows a novel, fast-resorbable antibacterial hydrogel coating can be safely used in patients undergoing internal osteosynthesis for closed fractures and cementless joint prosthesis without local or systemic side effects and no radiological signs of interference with bone healing,” Scarponi said. – by Robert Linnehan

Disclosures: Logoluso and Scarponi report the project was funded by a grant from the European Community, “Implant Disposable Antibacterial Coating (I.D.A.C.): A Novel Approach to Implant-Related Infections,” 7th Framework Programme on Research Technological Development and Demonstration, grant no. 277988.