Prospective Comparison of Wound Complications After Anterior Total Ankle Arthroplasty With and Without PICO Negative Pressure Incisional Dressing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Wound complications
研究概览
简要总结
To compare the rate of wound complications with the PICO dressing versus a standard nonstick gauze dressing in patients undergoing anterior total ankle arthroplasty.
详细描述
Participating subjects will be randomized to one of the study groups: Group 1 (Control group) or Group 2 (Treatment group). If randomized to Group 1- after surgery, the doctor will apply the standard non-stick gauze dressing to the wound. If randomized to Group 2- after surgery, the doctor will apply the PICO dressing to the wound.
The goal of the study is to measure the rate of wound complications based on wound assessment, patient-reported outcomes surveys, as well as peri- and post-operative data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient ≥18 years old
- •Subjects undergoing total ankle arthroplasty or uncomplicated revision total ankle arthroplasty
- •Subjects able to provide informed consent
- •Subjects who are able to understand and comply with study visit schedule and procedures
排除标准
- •History of previous deep infection or history of wound complication necessitating plastic surgery intervention
- •Allergy to products used in the study
- •Pregnant and breastfeeding women due to anesthesia risks
- •Subjects with a known history of poor compliance with medical treatment
- •Subjects who decline participation in this research study
- •Prisoners
结局指标
主要结局
Wound complications
时间窗: Approximately 12-weeks after surgery (or until 3-month postop visit is completed)
To determine presence or absence of wound complications at the follow-up visits.
次要结局
未报告次要终点
研究者
Walter C Hembree
MD
Medstar Health Research Institute