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经皮穿针闭合复位治疗儿童肱骨髁上骨折预防性应用抗生素对感染率的影响:一项前瞻性、双盲、随机对照临床试验。

Effect of Antibiotic Prophylaxis on Infection Rates in Pediatric Supracondylar Humerus Fractures Treated with Closed Reduction and Percutaneous Pinning: A Prospective Double-Blinded Randomized Controlled Trial.

机构信息

From the Department of Orthopaedic Surgery, University of Missouri, Columbia, MO.

出版信息

J Am Acad Orthop Surg. 2024 May 1;32(9):410-416. doi: 10.5435/JAAOS-D-23-00795. Epub 2024 Feb 28.

Abstract

BACKGROUND

Supracondylar humerus fractures (SCHFs) are the most common elbow fracture in the pediatric population. In the case of displaced fractures, closed reduction and percutaneous Kirschner wire pinning (CRPP) is commonly performed. Infection rates are between 0 and 7%; however, retrospective studies have shown no benefit of preoperative antibiotics. There continues to be notable variability in antibiotic usage based on surgeon preference and local institutional policy. We conducted a double-blinded, randomized controlled trial to evaluate whether antibiotic prophylaxis reduces the risk of infection in pediatric SCHF patients treated with CRPP.

METHODS

Pediatric patients with displaced SCHF who presented to a pediatric hospital were enrolled and randomized into two groups. Group I received one dose of prophylactic antibiotics (25 mg/kg cefazolin IV up to 1g or clindamycin 10 mg/kg up to 600 mg/kg IV in the case of cefazolin allergy). Group II received placebo (10-mL prefilled syringe of normal saline). All patients underwent CRPP and casting followed by pin removal 3 to 6 weeks after the initial procedure. The presence of pin-site infection, erythema, drainage, septic arthritis, and osteomyelitis was recorded.

RESULTS

One hundred sixty patients were enrolled in the study. Eighty-two patients were randomized to receive antibiotics, and 78 patients were randomized to placebo. No difference was seen in the rate of infection between the treatment groups (1.2% in the antibiotic group versus 1.3% in the placebo group; P = 1.00). Presence of purulent drainage (0.0% versus 1.3%; P = 0.49), septic arthritis (0.0% versus 0.0%; P = 1.00), and osteomyelitis (1.2% versus 0.0%; P = 1.00) was similar in both groups. No difference in the need for additional antibiotics (1.2% versus 1.3%; P = 1.00) or additional surgery (1.2% versus 0.0%; P = 1.00) was found between groups.

DISCUSSION

The use of antibiotic prophylaxis did not affect the risk of infection in pediatric patients who underwent CRPP for displaced SCHF.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov: NCT03261830.

LEVEL OF EVIDENCE

Therapeutic Level I.

摘要

背景

肱骨髁上骨折(SCHF)是儿童中最常见的肘部骨折。对于移位性骨折,通常采用闭合复位经皮克氏针固定(CRPP)。感染率在 0 至 7%之间;然而,回顾性研究表明术前使用抗生素没有益处。根据外科医生的偏好和当地机构政策,抗生素的使用仍存在显著差异。我们进行了一项双盲、随机对照试验,以评估 CRPP 治疗小儿 SCHF 患者时,抗生素预防是否降低感染风险。

方法

患有移位性 SCHF 的儿科患者就诊于一家儿童医院,他们被纳入并随机分为两组。I 组接受一剂预防性抗生素(25mg/kg 头孢唑林 IV 最大 1g 或头孢唑林过敏时 10mg/kg 克林霉素 IV 最大 600mg/kg)。II 组接受安慰剂(10 毫升预装生理盐水注射器)。所有患者均接受 CRPP 和石膏固定,然后在初始手术后 3 至 6 周取出克氏针。记录针道感染、红斑、引流、化脓性关节炎和骨髓炎的发生情况。

结果

本研究共纳入 160 例患者。82 例患者被随机分配接受抗生素治疗,78 例患者被随机分配接受安慰剂。治疗组之间的感染率无差异(抗生素组 1.2%,安慰剂组 1.3%;P=1.00)。脓性引流(0.0%与 1.3%;P=0.49)、化脓性关节炎(0.0%与 0.0%;P=1.00)和骨髓炎(1.2%与 0.0%;P=1.00)的发生率在两组之间相似。两组之间需要额外使用抗生素(1.2%与 1.3%;P=1.00)或进一步手术(1.2%与 0.0%;P=1.00)的差异无统计学意义。

讨论

对于接受 CRPP 治疗的移位性 SCHF 患儿,使用抗生素预防并未影响感染风险。

临床试验注册

ClinicalTrials.gov:NCT03261830。

证据水平

治疗性 I 级。

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