Safe Access: Randomized Trial to Compare Removal Techniques for the One-Rod Subdermal Contraceptive Implant: RemovAid Device Versus Standard Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- RemovAid AS
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Number of women who have post-removal complications -
研究概览
简要总结
This randomized trial will compare different approaches to removing a subdermal contraceptive implant from the upper arm of 225 women in Uganda. The experimental approach is a hand-held device (RemovAid) that incises the skin and grasps the implant for extraction. Safety and efficacy endpoints will be compared to the traditional removal approach (scalpel, forceps, tweezers).
详细描述
The trial assigns participants to one of three arms: RemovAid+lidocaine patch (n=75), RemovAid+lidocaine injection (n=75) or traditional approach+lidocaine injection(n=75). Complication rates in the different arms will be compared. Efficacy (successful implant removal) will be the secondary comparisons. Finally, pain during removal and duration of removal procedure will be compared. Participants will return to the clinic within 4 weeks of the removal procedure to record the healing process and final interventions (if any).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •seeking voluntary removal of a one-rod subdermal implant
- •willing to sign an informed consent document
- •willing to be randomized to the new device vs. standard technique
- •willing to follow-up at the study clinic for any subsequent removal-related complications
- •willing to have any follow-up complications recorded and shared
- •has an implant that is completely and easily palpable
- •has an implant that is easily pinched and lifted
- •no known allergies to skin preparation products or local anesthetics
排除标准
- •Implants that are not easily palpable
- •Previous failed implant removal
结局指标
主要结局
Number of women who have post-removal complications -
时间窗: 4 weeks
Complications will include unusual level of trauma to the skin (bruising/hematoma), excessive bleeding, use of sutures to repair skin after removal, inability to remove the implant, implant breakage or severing at time of removal, subsequent infection at the removal site, and other complications that may be noted by the investigator
Number of implants that are successfully removed
时间窗: 0-3 hours
The number of implants successfully removed i) without breaking the implant and without additional tools (scalpel, tweezers, or forceps), ii) without additional tools, iii) without the additional use of a scalpel.
次要结局
- Provider feedback on device on ways the product helped or hindered implant removal(0-3 hours)
- Participant pain level(0-3 hours)
- Provider feedback on device on whether RemovAid device helped with removal of implant(0-3 hours)
- Duration of removal procedure(0-3 hours)