Sprague Sheila, Guyatt Paige, Bzovsky Sofia, Nguyen Uyen, Bhandari Mohit, Thabane Lehana, Petrisor Brad, Johal Herman S, Leonard Jordan, Dodds Shannon, Mossuto Franca, O'Toole Robert V, Howe Andrea, Demyanovich Haley K, Camara Megan, O'Hara Nathan N, Slobogean Gerard P
Division of Orthopedic Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada.
Pilot Feasibility Stud. 2021 Mar 1;7(1):61. doi: 10.1186/s40814-021-00800-8.
Preoperative antiseptic skin solutions are used prior to most surgical procedures; however, there is no definitive research comparing infection-related outcomes following use of the various solutions available to orthopedic trauma surgeons. The objective of this pilot study was to test the feasibility of a cluster randomized crossover trial that assesses the comparative effectiveness of a 10% povidone-iodine solution versus a 4% chlorhexidine gluconate solution for the management of open fractures.
Two orthopedic trauma centers participated in this pilot study. Each of these clinical sites was randomized to a starting solution (povidone-iodine solution or chlorhexidine gluconate) then subsequently crossed over to the other treatment after 2 months. During the 4-month enrollment phase, we assessed compliance, enrollment rates, participant follow-up, and accurate documentation of the primary clinical outcome. Feasibility outcomes included (1) the implementation of the interventions during a run-in period; (2) enrollment of participants during two 2-month enrollment phases; (3) application of the trial interventions as per the cluster randomization crossover scheme; (4) participant follow-up; and (5) accurate documentation of the primary outcome (surgical site infection). Feasibility outcomes were summarized using descriptive statistics reported as means (standard deviation) or medians (first quartile, third quartile) for continuous variables depending on their distribution and counts (percentage) for categorical variables. Corresponding 95% confidence intervals (CIs) were also reported.
All five of the criteria for feasibility were met. During the run-in phase, all 18 of the eligible patients identified at the two clinical sites received the correct cluster-assigned treatment. A total of 135 patients were enrolled across both sites during the 4-month recruitment phase, which equates to 92% (95% CI 85.9 to 96.4%) of eligible patients being enrolled. Compliance with the assigned treatment in the pilot study was 98% (95% CI 93.5 to 99.8%). Ninety-eight percent (95% CI 93.5 to 99.8%) of participants completed the 90-day post-surgery follow-up and the primary outcome (SSI) was accurately documented for 100% (95% CI 96.6 to 100.0%) of the participants.
These results confirm the feasibility of a definitive study comparing antiseptic solutions using a cluster randomized crossover trial design. Building upon the infrastructure established during the pilot phase, a definitive study has been successfully initiated.
ClincialTrials.gov , number NCT03385304 . Registered December 28, 2017.
大多数外科手术前都会使用术前抗菌皮肤溶液；然而，对于骨科创伤外科医生可获得的各种溶液使用后与感染相关的结果，尚无明确的研究进行比较。这项初步研究的目的是测试一项整群随机交叉试验的可行性，该试验评估10%聚维酮碘溶液与4%葡萄糖酸氯己定溶液在开放性骨折治疗中的相对有效性。
两个骨科创伤中心参与了这项初步研究。每个临床地点被随机分配一种起始溶液（聚维酮碘溶液或葡萄糖酸氯己定溶液），然后在2个月后交叉使用另一种治疗方法。在4个月的入组阶段，我们评估了依从性、入组率、参与者随访情况以及主要临床结果的准确记录。可行性结果包括：（1）在试运行期内实施干预措施；（2）在两个2个月的入组阶段招募参与者；（3）按照整群随机交叉方案应用试验干预措施；（4）参与者随访；（5）准确记录主要结果（手术部位感染）。可行性结果使用描述性统计进行总结，连续变量根据其分布情况报告为均值（标准差）或中位数（第一四分位数、第三四分位数），分类变量报告为计数（百分比）。还报告了相应的95%置信区间（CI）。
所有五项可行性标准均得到满足。在试运行阶段，两个临床地点确定的所有18名符合条件的患者均接受了正确分配的整群治疗。在4个月的招募阶段，两个地点共招募了135名患者，这相当于92%（95%CI 85.9%至96.4%）的符合条件患者被纳入研究。初步研究中对分配治疗的依从性为98%（95%CI 93.5%至99.8%）。98%（95%CI 93.5%至99.8%）的参与者完成了术后90天的随访，100%（95%CI 96.6%至100.0%）的参与者的主要结果（手术部位感染）得到了准确记录。
这些结果证实了使用整群随机交叉试验设计比较抗菌溶液的确定性研究的可行性。在初步阶段建立的基础设施基础上，一项确定性研究已成功启动。
ClinicalTrials.gov，编号NCT03385304。2017年12月28日注册。
