Iodinated Adhesive Drapes for Repeat Cardiac Implantable Device Implantation: A Randomized Clinical Trial.

Preventing contamination at this stage may significantly reduce the risk of infections.

在这个阶段预防污染可能会显著降低感染风险。

Background

To determine whether the application of an intraoperative adhesive iodine-impregnated drape would reduce the rate of end-of-procedure pocket-swab positivity and subsequent CIED infections.

确定应用术中粘附性含碘消毒布是否能降低手术结束时囊袋拭子阳性率及随后的心脏植入电子装置（CIED）感染率。

DESIGN, SETTING, AND PARTICIPANTS: This was a prospective, double-armed, single-blinded, randomized clinical trial, conducted from November 2020 to May 2024.

设计、环境和参与者：这是一项前瞻性、双臂、单盲、随机临床试验，从2020年11月开始至2024年5月进行。

Patients, the staff performing the swabs, and the microbiologists were blinded to group assignments.

患者、执行拭子操作的工作人员以及微生物学家均不了解分组情况。

This was a single-center study that included patients undergoing repeat procedures on the same device pocket.

这是一项单中心研究，包括在同一个设备袋上进行重复操作的患者。

These patients were randomized in a 1:1 ratio to either the iodine-impregnated drape group or the control group.

这些患者按照1:1的比例随机分配到碘浸渍布单组或对照组。

intervention

Application of an iodine-impregnated drape at the beginning of the procedure.

在手术开始时应用碘浸渍布单。

main_outcomes_and_measures

The primary end point was end-of-procedure pocket-swab culture positivity.

主要终点是手术结束时口袋拭子培养阳性。

Results

A total of 418 patients were randomized (210 to the drape group and 208 to the no-drape group).

共有418名患者被随机分配（210名患者进入覆盖组，208名患者进入无覆盖组）。

The final analysis included 189 patients in the drape group and 195 patients in the no-drape group, with both groups well balanced in demographics.

最终分析包括了189名覆盖组患者和195名无覆盖组患者，两组在人口统计学特征上均衡。

In the drape group, 143 participants were male (75.7%), and mean (SD) age was 73.9 (12.1) years; in the no-drape group, 140 were male (71.8%), and mean (SD) age was 73.2 (12.6) years.

在覆盖组中，143名参与者为男性（75.7%），平均年龄（标准差）为73.9（12.1）岁；在无覆盖组中，140名为男性（71.8%），平均年龄（标准差）为73.2（12.6）岁。

Pocket-swab culture positivity was found in 19 of 189 patients (10.1%) in the drape group compared with 40 of 195 patients (20.5%) in the no-drape group (relative risk reduction [RRR], 0.50; 95% CI, 0.24-0.75; P = .005).

在使用遮盖物组的189名患者中，有19名（10.1%）患者的囊袋拭子培养呈阳性，而在未使用遮盖物组的195名患者中，有40名（20.5%）患者的囊袋拭子培养呈阳性（相对风险降低[RRR]，0.50；95%置信区间，0.24-0.75；P = .005）。

Adjudicated CIED infections occurred in 4 of 195 patients (1.9%) in the no-drape group vs 0 of 189 in the drape group (P = .02).

在未使用遮盖物组的195名患者中，有4名（1.9%）患者发生了经裁定的CIED感染，而在使用遮盖物组的189名患者中，没有患者发生CIED感染（P = .02）。

CIED infections were observed in 2 of 59 patients (3.4%) with positive swabs and in 2 of 325 patients (0.6%) with negative swabs (odds ratio, 5.67; 95% CI, 0.78-41.04; P = .08).

在59名拭子阳性患者中观察到2例心脏植入电子设备（CIED）感染（3.4%），而在325名拭子阴性患者中观察到2例（0.6%）（比值比，5.67；95%置信区间，0.78-41.04；P = .08）。

conclusions_and_relevance

In this randomized clinical trial, the use of iodine-impregnated drapes during repeat CIED implantation resulted in reduction in swab culture positivity and 1-year CIED infection rates.

在这项随机临床试验中，使用含碘消毒布在重复心脏植入电子设备（CIED）植入过程中，导致拭子培养阳性率和1年CIED感染率的降低。

This is a simple and cost-effective intervention to reduce CIED pocket contamination and subsequent infections.

这是一种简单且成本效益高的干预措施，用于减少心脏植入电子设备（CIED）囊袋污染及其后续感染。

trial_registration

ClinicalTrials.gov Identifier: NCT04591366.

ClinicalTrials.gov注册号：NCT04591366。