目的:用于移除单杆皮下避孕植入物的机械手持装置对植入物使用者安全吗?
结论:就安全性而言,该装置是不劣于植入物去除的标准技术。
背景:在熟练的提供者供不应求的情况下,易于使用的用于移除皮下避孕植入物的装置可能会有所帮助。在这项研究之前,世界上唯一的第一份手持报告,带有内置门牙的机械装置是瑞典的一项研究,使用该产品的早期版本。
方法:从2019年12月到2020年11月,我们进行了三臂,一项开放标签的非劣效性随机试验,涉及225名乌干达妇女,以评估新开发的植入物的安全性(主要结局)并测量植入物的去除功效(次要结局),手持设备,与标准去除技术相比。
方法:我们以1:1:1的比例:标准技术/利多卡因注射,将希望移除其单杆避孕植入物的参与者随机分组,新装置/利多卡因贴片或新装置/利多卡因注射。对于主要安全终点,我们检查了手术切除并发症,并根据严重程度进行分组.对于疗效的次要终点,我们定义了三个装置结果:在没有额外工具的情况下移除完整的植入物(主要),移除植入物,允许植入物破损,但没有工具(二级)和植入物移除允许植入物破损和非手术刀工具(三级)。我们评估了提供者对设备的反馈,并对所有比较使用卡方检验。
结果:我们招募了225名参与者,并随机分配(n=75)到每组。为了安全,任何治疗组均无主要并发症发生,而每个治疗组仅发生1次并发症(1%)。主要疗效为100%(标准技术),85%(新装置/利多卡因贴片)和73%(新装置/利多卡因注射)(P<0.0001)。次要疗效为100%(标准技术),92%(新装置/利多卡因贴片)和79%(新装置/利多卡因注射)(P<0.0001)。三级疗效为100%(标准技术),96%(新装置/利多卡因贴剂)和91%(新装置/利多卡因注射液)(P=0.017)。使用新设备不成功的移除不会阻碍随后使用标准备用工具进行植入物提取。在150个设备程序中的90%以上,供应商同意或强烈同意该产品是标准去除技术的可接受替代品。
结论:我们在擅长标准去除技术的乌干达护士手中测试了一种新的去除装置;我们对去除功效的估计可能不适用于可能是这项技术的主要受益者的低级提供者。
结论:该研究是在世界的一个地区进行的,该地区的新设备可用于扩大获得植入物移除服务的途径。新产品的预期受益者是植入物使用者,他们无法轻易找到熟练的提供者进行传统的依赖手术刀的移除和/或被手术刀程序吓倒的使用者,以及可以接受培训以帮助提供服务以满足不断增长的需求的较低级别的提供商。新设备是保险箱,可接受的替代方案;疗效高,但不能与标准技术相提并论。
背景:这项研究的资金由挪威的RemovAidAS提供,并获得了挪威研究委员会的资助(GLOBVAC编号228319),比尔和梅琳达·盖茨基金会(INV-007571)和SkatteFUNN。M.B.是RemovAidAS的创始人和前首席执行官,挪威。M.B.持有避孕棒去除剂专利(2012年1307156.8和2015年),拆除前测试(已归档)和在RemovAidAS中的股份。所有其余作者的机构都以合同的形式获得了付款,以帮助进行研究;这些合同的资金来自RemovAidAS。
背景:NCT04120337。
■2019年10月9日。
■2019年12月23日。
OBJECTIVE: Is a mechanical hand-held device for removing a single-rod subdermal contraceptive implant safe for implant users?
CONCLUSIONS: In terms of safety, the device is non-inferior to the standard technique for implant removal.
BACKGROUND: An easy-to-use device for removing a subdermal contraceptive implant may be helpful in settings where skilled providers are in short supply. Prior to this study, the only report on the world\'s first hand-held, mechanical device with build-in incisor was a Swedish study using earlier versions of the product.
METHODS: From December 2019 to November 2020, we conducted a three-arm, open-label non-inferiority randomized trial involving 225 Ugandan women to assess safety (primary outcome) and measure implant removal efficacy (secondary outcomes) of a newly developed, hand-held device, compared to the standard removal technique.
METHODS: We randomized participants desiring removal of their one-rod contraceptive implant in a 1:1:1 ratio: standard technique/lidocaine injection, new device/lidocaine patch or new device/lidocaine injection. For primary safety endpoints, we examined removal complications and grouped them according to severity. For secondary endpoints on efficacy, we defined three device outcomes: intact implant removed without additional tools (primary), implant removed allowing implant breakage, but without tools (secondary) and implant removed allowing implant breakage and non-scalpel tools (tertiary). We assessed provider feedback on the device and used chi-square tests for all comparisons.
RESULTS: We recruited 225 participants and randomly assigned (n = 75) to each group. For safety, no primary complications occurred in any treatment group, while only one secondary complication occurred in each treatment group (1%). Primary efficacy was 100% (standard technique), 85% (new device/lidocaine patch) and 73% (new device/lidocaine injection) (P < 0.0001). Secondary efficacy was 100% (standard technique), 92% (new device/lidocaine patch) and 79% (new device/lidocaine injection) (P < 0.0001). Tertiary efficacy was 100% (standard technique), 96% (new device/lidocaine patch) and 91% (new device/lidocaine injection) (P = 0.017). Unsuccessful removals with the new device did not hinder subsequent implant extractions with standard back-up tools. In over 90% of the 150 device procedures, providers agreed or strongly agreed that the product is an acceptable alternative to standard removal technique.
CONCLUSIONS: We tested a new removal device in the hands of Ugandan nurses who were adept at standard removal techniques; our estimates of removal efficacy may not apply to lower-level providers who arguably may be the prime beneficiaries of this technology.
CONCLUSIONS: The study was conducted in a region of the world where the new device could be used to expand access to implant removal services. Intended beneficiaries of the new product are implant users who cannot easily find skilled providers for traditional scalpel-dependent removals and/or users who are intimidated by scalpel procedures, and lower-level providers who can be trained to help deliver services to meet a growing demand. The new device is a safe, acceptable alternative; efficacy was high, but not on par with standard technique.
BACKGROUND: Funding for this study was provided by the RemovAid AS of Norway with grants from Research Council of Norway (GLOBVAC number 228319), Bill & Melinda Gates Foundation (grant INV-007571) and SkatteFUNN. M.B. is founder and former CEO of RemovAid AS, Norway. M.B. holds contraceptive rod remover patents (2012 1307156.8 and 2015), pre-removal test (filed) and shares in RemovAid AS. All of the remaining authors\' institutions received payments in the form of contracts to help conduct the study; the funds for these contracts emanated from RemovAid AS.
BACKGROUND: NCT04120337.
UNASSIGNED: 9 October 2019.
UNASSIGNED: 23 December 2019.