Divisions of Infectious Diseases, Brigham and Women’s Hospital, Boston, Massachusetts, USA.
JAMA Surg. 2013 May;148(5):440-6. doi: 10.1001/jamasurg.2013.1372.
To determine whether extended postoperative antibacterial prophylaxis for patients undergoing elective thoracic surgery with tube thoracostomy reduces the risk of infectious complications compared with preoperative prophylaxis only.
Prospective, randomized, double-blind, placebo-controlled trial.
Brigham and Women's Hospital, an 800-bed tertiary care teaching hospital in Boston, Massachusetts.
A total of 251 adult patients undergoing elective thoracic surgery requiring tube thoracostomy between April 2008 and April 2011.
Patients received preoperative antibacterial prophylaxis with cefazolin sodium (or other drug if the patient was allergic to cefazolin). Postoperatively, patients were randomly assigned (at a 1:1 ratio) using a computer-generated randomization sequence to receive extended antibacterial prophylaxis (n = 125) or placebo (n = 126) for 48 hours or until all thoracostomy tubes were removed, whichever came first.
The combined occurrence of surgical site infection, empyema, pneumonia, and Clostridium difficile colitis by postoperative day 28.
A total of 245 patients were included in the modified intention-to-treat analysis (121 in the intervention group and 124 in the placebo group). Thirteen patients (10.7%) in the intervention group and 8 patients (6.5%) in the placebo group had a primary end point (risk difference, -4.3% [95% CI, -11.3% to 2.7%]; P = .26). Six patients (5.0%) in the intervention group and 5 patients (4.0%) in the placebo group developed surgical site infections (risk difference, -0.93% [95% CI, -6.1% to 4.3%]; P = .77). Seven patients (5.8%) in the intervention group and 3 patients (2.4%) in the placebo group developed pneumonia (risk difference, -3.4% [95% CI, -8.3% to 1.6%]; P = .21). One patient in the intervention group developed empyema. No patients experienced C difficile colitis.
Extended postoperative antibacterial prophylaxis for patients undergoing elective thoracic surgery requiring tube thoracostomy did not reduce the number of infectious complications compared with preoperative prophylaxis only.
clinicaltrials.gov Identifier: NCT00818766.
确定与仅术前预防相比，对接受胸腔管引流的择期开胸手术患者进行延长术后抗菌预防是否降低感染并发症的风险。
前瞻性、随机、双盲、安慰剂对照试验。
马萨诸塞州波士顿的布里格姆妇女医院，一家拥有 800 张床位的三级护理教学医院。
2008 年 4 月至 2011 年 4 月期间接受择期开胸手术且需要胸腔管引流的 251 例成年患者。
患者接受头孢唑林钠术前抗菌预防（如果患者对头孢唑林过敏，则使用其他药物）。术后，患者使用计算机生成的随机序列以 1:1 的比例随机分配（n = 125）接受延长抗菌预防（n = 126）48 小时或直至所有胸腔管被移除，以先到者为准。
术后第 28 天发生手术部位感染、脓胸、肺炎和艰难梭菌结肠炎的综合发生率。
共有 245 例患者纳入意向治疗的改良分析（干预组 121 例，安慰剂组 124 例）。干预组 13 例（10.7%）和安慰剂组 8 例（6.5%）患者出现主要终点（风险差异，-4.3%[95%CI，-11.3%至 2.7%]；P =.26）。干预组 6 例（5.0%）和安慰剂组 5 例（4.0%）患者发生手术部位感染（风险差异，-0.93%[95%CI，-6.1%至 4.3%]；P =.77）。干预组 7 例（5.8%）和安慰剂组 3 例（2.4%）患者发生肺炎（风险差异，-3.4%[95%CI，-8.3%至 1.6%]；P =.21）。干预组 1 例患者发生脓胸。没有患者发生艰难梭菌结肠炎。
与仅术前预防相比，对接受胸腔管引流的择期开胸手术患者进行延长术后抗菌预防并不能降低感染并发症的数量。
clinicaltrials.gov 标识符：NCT00818766。
