NCT06661473进行中（未招募）不适用
An Interventional Study to Explore the Occurrence of Surgical Site Complications in High-risk Patients After Revision of Total Hip or Knee Joint Arthroplasty Receiving Closed Incision Negative Pressure Wound Therapy.
Molnlycke Health Care AB16 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2024年10月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 105
- 试验地点
- 16
- 主要终点
- Incidence of surgical site infections
研究概览
简要总结
Interventional study exploring surgical site complication occurrences in high-risk revision patients undergoing TKA or THA using NPWT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •Written informed consent
- •Patient ≥ 18 years
- •Elective unilateral revision THA or TKA.
- •High risk patients for surgical wound complications as deemed by investigators
- •Primary closure technique by suture or staples
- •Linear or curvilinear incisions ≤ 25 cm in length
- •The patient able to understand the study and is willing to consent to the clinical investigation
- •Patients able to understand how to operate with the negative pressure system at home
排除标准
- •The need for emergency surgery
- •Multiple Incision Approach at the time of surgery (alternative approach from primary surgery using 1 incision is permitted)
- •Patients requiring bilateral revision total hip or knee arthroplasty surgery
- •Active infections of the offending joint.
- •History of multiple infections in the offending joint
- •Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and superabsorbent powders (polyacrylates) (within the dressing)
- •Subjects with contraindications (as per the Avance Solo Instructions for use)
- •Pregnant, breastfeeding females, or females of childbearing potential not willing to use contraception for the duration of the investigation
- •Patients with presence of remote skin infection or active systemic infection at the time of revision surgery.
- •Patient with incisions > 25cm in length or type of incisions that cannot be sufficiently covered by Avance Solo Border dressing (i.e., the wound pad does not overlap the edges of the incision by at least 1.5 cm as per the IFU)
- •Use of surgical glue as part of incisional closure method
- •Patients who in the opinion of the investigator may not complete or comply with follow up treatment for any reason
- •Patients participating in ongoing clinical investigations, or during the past 30 days, that may impact the outcome of this investigation based on the judgement of the investigator.
- •Any clinically significant condition that, in the investigator's opinion, would significantly impair the subject's ability to comply with the study
结局指标
主要结局
Incidence of surgical site infections
时间窗: 90 days from revision surgery
次要结局
未报告次要终点
研究者
研究点 (16)
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