Paiement G D, Renaud E, Dagenais G, Gosselin R A
San Francisco General Hospital, University of California.
J Orthop Trauma. 1994;8(1):64-6. doi: 10.1097/00005131-199402000-00014.
Antibioprophylaxis has been proven to be efficient for some orthopaedic procedures. However, its efficacy for clean limited procedures with metallic implants is not clear. One hundred twenty-two closed ankle fracture patients undergoing open reduction and internal fixation were randomized, double-blindly, to receive either cephalothin (1 g i.v. every 6 h x four doses) or a placebo starting before tourniquet application. Mean trauma-surgery delay was 30.2 h, and average tourniquet duration was 65.4 min. Four patients (three of 62 on placebo and one of 60 on cephalothin) developed a superficial wound infection. One of the patients in the placebo group was hospitalized and treated with i.v. antibiotics. However, there was no osteomyelitis or premature hardware removal. The difference between the two groups was not statistically significant (chi 2 test of appreciation p = 0.33, two-tailed probabilities). Therefore, cephalothin prophylaxis does not seem justified in this patient population. A larger series is needed to avoid a type II error.
抗生素预防已被证明对某些骨科手术有效。然而，其对使用金属植入物的清洁受限手术的疗效尚不清楚。122例接受切开复位内固定的闭合性踝关节骨折患者被随机双盲分组，在止血带应用前开始分别接受头孢噻吩（每6小时静脉注射1 g，共4剂）或安慰剂。平均创伤手术延迟时间为30.2小时，平均止血带使用时间为65.4分钟。4例患者（安慰剂组62例中的3例和头孢噻吩组60例中的1例）发生浅表伤口感染。安慰剂组的1例患者住院并接受静脉抗生素治疗。然而，没有发生骨髓炎或过早取出内固定物的情况。两组之间的差异无统计学意义（卡方检验p = 0.33，双侧概率）。因此，在该患者群体中，头孢噻吩预防似乎不合理。需要更大规模的系列研究以避免II类错误。
