为何使用同样的冲洗液：β-内酰胺类与生理盐水在小儿脊柱手术中污染率的比较
Why Irrigate for the Same Contamination Rate: Wound Contamination in Pediatric Spinal Surgery Using Betadine Versus Saline.
机构信息
Department of Orthopaedic Surgery, Boston Children's Hospital, Boston, MA.
Department of Orthopaedic Surgery, Children's Mercy Hospital and University of Missouri, Kansas City, MO.
出版信息
J Pediatr Orthop. 2020 Nov/Dec;40(10):e994-e998. doi: 10.1097/BPO.0000000000001620.
BACKGROUND
The risk of surgical site infection in pediatric posterior spine fusion (PSF) is up to 4.3% in idiopathic populations and 24% in patients with neuromuscular disease. Twenty-three percent of pediatric PSF tissue cultures are positive before closure, with a higher rate in neuromuscular patients. Our primary aim was to evaluate the feasibility of a complete randomized controlled trial to study the efficacy of surgical site irrigation with povidone-iodine (PVP-I) compared with sterile saline (SS) to reduce the bacterial contamination rate before closure in children undergoing PSF.
METHODS
One hundred seventy-five subjects undergoing PSF were enrolled in a multicenter, single-blind, pilot randomized controlled trial. We recruited patients at low-risk (LR) and high-risk (HR) for infection 3:1, respectively. Before closure, a wound culture was collected. Nonviable tissues were debrided and the wound was soaked with 0.35% PVP-I or SS for 3 minutes. The wound was then irrigated with 2 L of saline and a second sample was collected.
RESULTS
One hundred fifty-three subjects completed the protocol. Seventy-seven subjects were allocated to PVP-I (18 HR, 59 LR) and 76 to SS (19 HR, 57 LR). Cultures were positive in 18% (14/77) of PVP-I samples (2 HR, 12 LR) and in 17% (13/76) of SS samples (3 HR, 10 LR) preirrigation and in 16% (12/77) of PVP-I samples (5 HR, 7 LR) and in 18% (14/76) of SS samples (4 HR, 10 LR) postirrigation. Eight percent (3/37) HR subjects (1 PVP-I, 2 SS) experienced infection at 30 days postoperative. No LR subjects experienced infection.
CONCLUSIONS
Positive cultures were similar across treatment and risk groups. The bacterial contamination of wounds before closure remains high regardless of irrigation type. A complete randomized controlled trial would be challenging to adequately power given the similarity of tissue positivity across groups.
LEVEL OF EVIDENCE
Level II-pilot randomized controlled trial.
背景
在特发性人群中，儿童后路脊柱融合术（PSF）的手术部位感染风险高达 4.3%，而在神经肌肉疾病患者中则为 24%。23%的儿童 PSF 组织培养在关闭前呈阳性，神经肌肉疾病患者的阳性率更高。我们的主要目的是评估一项完全随机对照试验的可行性，以研究在接受 PSF 的儿童中，使用聚维酮碘（PVP-I）冲洗手术部位与使用无菌盐水（SS）冲洗相比，在关闭前降低细菌污染率的效果。
方法
175 名接受 PSF 的患者参与了一项多中心、单盲、初步随机对照试验。我们以 3:1 的比例分别招募感染低风险（LR）和高风险（HR）的患者。在关闭前，采集伤口培养物。去除无活力的组织，并将伤口浸泡在 0.35%PVP-I 或 SS 中 3 分钟。然后用 2 L 生理盐水冲洗伤口，并采集第二个样本。
结果
153 名患者完成了方案。77 名患者被分配到 PVP-I 组（18 名 HR，59 名 LR），76 名患者被分配到 SS 组（19 名 HR，57 名 LR）。预冲洗时，PVP-I 组 18%（14/77）的样本（2 名 HR，12 名 LR）和 SS 组 17%（13/76）的样本（3 名 HR，10 名 LR）为阳性，冲洗后 PVP-I 组 16%（12/77）的样本（5 名 HR，7 名 LR）和 SS 组 18%（14/76）的样本（4 名 HR，10 名 LR）为阳性。30 天后，8%（3/37）的 HR 患者（1 名 PVP-I，2 名 SS）发生感染。无 LR 患者发生感染。
结论
不同治疗组和风险组的培养阳性率相似。无论冲洗类型如何，关闭前伤口的细菌污染仍然很高。鉴于各组组织阳性率相似，完全随机对照试验可能难以充分发挥作用。
证据水平
二级-初步随机对照试验。
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