T A G van Vugt1, J M B Walraven1, J A P Geurts1, J J C Arts1. 1. Department of Orthopaedic Surgery (T.A.G.v.V., J.A.P.G., and J.J.C.A.) and Faculty of Health Medicine and Life Sciences (J.M.B.W.), Maastricht University Medical Centre (MUMC+), Maastricht, the Netherlands.
Abstract
BACKGROUND: Chronic osteomyelitis is caused by bacterial infection of the bone and is a major problem in orthopaedic surgery. Treatment of chronic osteomyelitis requires surgical debridement accompanied by local and systemic administration of antibiotics. A widely established biodegradable local antibiotic carrier is antibiotic-loaded collagen sponges (fleeces). These sponges are commonly used in the treatment of chronic osteomyelitis, but a systematic review of their clinical efficacy and assessment of the quality of evidence have not been conducted, to our knowledge. METHODS: This systematic review, performed according to the PRISMA statement, examined the clinical efficacy of and quality of evidence regarding different antibiotic-loaded collagen sponges in the clinical treatment of chronic osteomyelitis. Clinical efficacy was defined as eradication of infection with bone and wound-healing. In addition, the in vivo pharmacokinetics of the various collagen sponges were evaluated. Quality was based on the Level of Evidence, methodological quality, and risks of bias. RESULTS: A total of 813 articles were screened, and 10 were included. Gentamicin-sulfate sponges and gentamicin-sulfate/gentamicin-crobefate sponges were studied. A total of 413 patients were treated, with a success rate of 91%. Reported complications were fistulas, prolonged wound drainage, and wound-healing problems. In vivo pharmacokinetic profiles showed an average local antibiotic concentration that was above the minimum inhibitory concentration for only 5 days. The general quality of the included studies was low to moderate, and there was a moderate to high risk of bias. CONCLUSIONS: The evidence quality and Level of Evidence of the included studies were low, and the risk of bias in these studies was high. This makes the evidence regarding these sponges inconclusive, and no clinical decision-making can be based on these studies. Utilization of antibiotic-loaded collagen sponges in the treatment of chronic osteomyelitis should only be carried out with caution; studies with high-level evidence are needed. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.
BACKGROUND:Chronic osteomyelitis is caused by bacterial infection of the bone and is a major problem in orthopaedic surgery. Treatment of chronic osteomyelitis requires surgical debridement accompanied by local and systemic administration of antibiotics. A widely established biodegradable local antibiotic carrier is antibiotic-loaded collagen sponges (fleeces). These sponges are commonly used in the treatment of chronic osteomyelitis, but a systematic review of their clinical efficacy and assessment of the quality of evidence have not been conducted, to our knowledge. METHODS: This systematic review, performed according to the PRISMA statement, examined the clinical efficacy of and quality of evidence regarding different antibiotic-loaded collagen sponges in the clinical treatment of chronic osteomyelitis. Clinical efficacy was defined as eradication of infection with bone and wound-healing. In addition, the in vivo pharmacokinetics of the various collagen sponges were evaluated. Quality was based on the Level of Evidence, methodological quality, and risks of bias. RESULTS: A total of 813 articles were screened, and 10 were included. Gentamicin-sulfate sponges and gentamicin-sulfate/gentamicin-crobefate sponges were studied. A total of 413 patients were treated, with a success rate of 91%. Reported complications were fistulas, prolonged wound drainage, and wound-healing problems. In vivo pharmacokinetic profiles showed an average local antibiotic concentration that was above the minimum inhibitory concentration for only 5 days. The general quality of the included studies was low to moderate, and there was a moderate to high risk of bias. CONCLUSIONS: The evidence quality and Level of Evidence of the included studies were low, and the risk of bias in these studies was high. This makes the evidence regarding these sponges inconclusive, and no clinical decision-making can be based on these studies. Utilization of antibiotic-loaded collagen sponges in the treatment of chronic osteomyelitis should only be carried out with caution; studies with high-level evidence are needed. LEVEL OF EVIDENCE: Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.