Marianne Westberg1, Frede Frihagen1, Ole-Christian Brun2, Wender Figved3, Bjarne Grøgaard1, Haldor Valland4, Helge Wangen5, Finnur Snorrason2. 1. Department of Orthopaedic Surgery, Oslo University Hospital. 2. Department of Orthopaedic Surgery, Oslo University Hospital Department of Orthopaedic Surgery, Drammen Hospital. 3. Department of Orthopaedic Surgery, Bærum Hospital, Drammen. 4. Department of Surgery, Diakonhjemmet Hospital, Oslo. 5. Department of Orthopaedic Surgery, Elverum Hospital, Brumunddal, Norway.
Abstract
BACKGROUND:Surgical site infection (SSI) is a feared complication in hip arthroplasty, especially following femoral neck fracture in the elderly, associated with substantially increased morbidity, mortality, and costs. Gentamicin-containing collagen sponges are widely used for prevention of SSIs, but their effectiveness in joint replacement surgery remains unclear. METHODS: We performed a multicenter, randomized trial between February 2011 and July 2013. Eligible patients with femoral neck fracture undergoing hemiarthroplasty were randomly assigned to receive either intravenous antimicrobial prophylaxis alone or with the addition of 2 gentamicin-containing collagen sponges into the hip joint perioperatively. The primary end point was SSI according to the Centers for Disease Control and Prevention criteria within 30 days after surgery. RESULTS:Seven hundred thirty-nine patients were randomly assigned, 684 of whom were included in the modified intention-to-treat analysis. There was no statistical significant difference in SSI between the gentamicin-collagen group (16 of 329 patients [4.9%]) and the control group (19 of 355 patients [5.4%]) (relative risk [RR], 0.91 [95% confidence interval, .48-1.79]; P = .77). No significant differences were observed between the groups in superficial SSI (2 of 329 [0.6%] vs 3 of 355 [0.8%]; P = .99) and deep SSI (14 of 329 [4.3%] vs 16 of 355 [4.5%]; P = .87). There were no significant differences between the groups regarding type of bacteria isolated. CONCLUSIONS: Locally administered gentamicin-collagen sponges did not reduce the incidence of SSI in elderly patients treated with a hemiarthroplasty because of femoral neck fracture. CLINICAL TRIALS REGISTRATION: NCT01287780.
RCT Entities:
BACKGROUND: Surgical site infection (SSI) is a feared complication in hip arthroplasty, especially following femoral neck fracture in the elderly, associated with substantially increased morbidity, mortality, and costs. Gentamicin-containing collagen sponges are widely used for prevention of SSIs, but their effectiveness in joint replacement surgery remains unclear. METHODS: We performed a multicenter, randomized trial between February 2011 and July 2013. Eligible patients with femoral neck fracture undergoing hemiarthroplasty were randomly assigned to receive either intravenous antimicrobial prophylaxis alone or with the addition of 2 gentamicin-containing collagen sponges into the hip joint perioperatively. The primary end point was SSI according to the Centers for Disease Control and Prevention criteria within 30 days after surgery. RESULTS: Seven hundred thirty-nine patients were randomly assigned, 684 of whom were included in the modified intention-to-treat analysis. There was no statistical significant difference in SSI between the gentamicin-collagen group (16 of 329 patients [4.9%]) and the control group (19 of 355 patients [5.4%]) (relative risk [RR], 0.91 [95% confidence interval, .48-1.79]; P = .77). No significant differences were observed between the groups in superficial SSI (2 of 329 [0.6%] vs 3 of 355 [0.8%]; P = .99) and deep SSI (14 of 329 [4.3%] vs 16 of 355 [4.5%]; P = .87). There were no significant differences between the groups regarding type of bacteria isolated. CONCLUSIONS: Locally administered gentamicin-collagen sponges did not reduce the incidence of SSI in elderly patients treated with a hemiarthroplasty because of femoral neck fracture. CLINICAL TRIALS REGISTRATION: NCT01287780.
Authors: Denver P Linklater; Vladimir A Baulin; Saulius Juodkazis; Russell J Crawford; Paul Stoodley; Elena P Ivanova Journal: Nat Rev Microbiol Date: 2020-08-17 Impact factor: 60.633