TRAUMA
Effect of Antibiotic Prophylaxis on Surgical Site Infections Following Removal of Orthopedic Implants Used for Treatment of Foot, Ankle, and Lower Leg Fractures: A Randomized Clinical Trial
This report has been verified
by one or more authors of the
original publication.
この研究はハイインパクトの可能性があります。
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最先端の自然言語処理を用いて開発されたOEハイインパクトモデルは、ジャーナルのインパクトファクターのみよりも、研究の将来の引用実績をより正確に予測します。
これにより、臨床的に意義のある研究をより早く認識することが可能になり、読者は将来の診療を形成する可能性が最も高い論文に集中することができます。
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2018;6(9):18 JAMA. 2017 Dec 26;318(24):2438-2445477 patients who had previously undergone internal fixation for a fracture of the foot, ankle, or lower leg were randomized to either prophylactic cefazolin or saline during routine implant removal. The primary outcome was the development of surgical site infection within 4 weeks of implant removal. Overall, no significant difference in the rate of surgical site infection was observed between the cefazolin group and the saline group.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
4/4
Randomization
4/4
Outcome Measurements
4/4
Inclusion / Exclusion
2/4
Therapy Description
4/5
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
While not always routine, removal of orthopaedic implants used for fracture healing is often undergone. Antibiotic prophylaxis is often used at the time of fracture fixation, but not at implant removal. It is this reason that some researchers speculate that surgical site infection rates during implant removal are higher than should be expected. Therefore, routine antibiotic prophylaxis may be an effective intervention to reduce surgical site infection rate after implant removal for a lower limb fracture.
主な研究課題は何ですか？
In the removal of an implant after internal fixation of a fracture below the knee, does a prophylactic dose of cefazolin 1000mg result in a significantly lower rate of surgical site infection when compared to intravenous saline?
重要な知見は？
- The incidence of SSI did not significantly differ between the cefazolin group (30/228; 13.2%) and the saline group (36/242; 14.9%) (p=0.60).
- The rate of superficial SSI was 29/228 in the cefazolin group and 29/242 in the saline group. The rate of deep SSI was 1/228 in the cefazolin group and 7/242 in the saline group.
最も覚えておくべきことは？
A preoperative, prophylactic dose of cefazolin did not significantly reduce the rate of surgical site infection compared to control saline in implant removal following fixation of a lower leg fracture.
それが私の患者ケアにどのように影響するか？
The results of this study suggest that routine intravenous antibiotic prophylaxis is not necessary among patients scheduled for removal of an implant for a previous lower leg fracture.
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