Wound Healing Outcomes With and Without the Alexis Wound Retractor in Direct Anterior Approach Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Number of Days to Identification of Delayed Wound Healing
研究概览
简要总结
To determine if there is a difference in wound healing and surgical site infection (SSI) rates using the Alexis wound retractor vs. not using it in longitudinal direct anterior approach total hip arthroplasty.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing primary unilateral longitudinal direct anterior approach total hip arthroplasty
- •Patients undergoing primary total hip arthroplasty
排除标准
- •Patients with history of prior open surgery on the affected hip
- •Patients with history of prior total hip arthroplasty on the contralateral hip
- •Patients with allergies or absolute contraindication to standardized drugs administered within the University of Miami protocol for total hip replacement
研究组 & 干预措施
Alexis Retractor
Subjects in this arm will undergo surgery using the Alexis wound retractor.
干预措施: Alexis wound retractor (Device)
Non-Alexis Retractor
Subjects in this arm will undergo surgery using a standard retractor that does not include the Alexis device.
干预措施: Standard wound retractor (Device)
结局指标
主要结局
Number of Days to Identification of Delayed Wound Healing
时间窗: Up to 14 days
Delayed wound healing is defined as the presence of one or more of the following clinical signs: drainage from wound, wound dehiscence, and superficial surgical site infection. Assessment is performed by clinical examination and documentation in the postoperative period. The outcome is measured in number of days from surgery to identification of delayed healing
Scar cosmesis as measured by Observer Scar Assessment Scale
时间窗: Up to 12 months
Using the Observer Scar Assessment Scale, which is a validated plastic surgery tool for evaluating scars from the observer perspective. Measured with a scale from 0 to 10, higher score indicates worse scar cosmesis.
Patient satisfaction with scaring as measured by Patient Scar Assessment Scale
时间窗: Up to 12 months
Using the Patient Scar Assessment Scale, which is a validated plastic surgery tool for evaluating scars from the patient's perspective. Measured with a scale from 0 to 10, higher score indicates less satisfaction.
次要结局
- Length of surgery(Up to 3 hours)
- Number of Participants Reporting Lateral Femoral Cutaneous Nerve (LFCN) Symptoms(Up to 6 months)
- Hip Disability and Osteoarthritis Outcome Score (HOOS) - Patient-Reported Outcome(Up to 12 months)
- Number of Intraoperative fractures(Up to 3 hours (duration of surgery))
- Number of Postoperative Complications(Up to 90 days)
研究者
Victor Hugo Hernandez
Professor of Orthopaedic Surgery
University of Miami