Single-Center, Randomized Trial to Study the Efficacy of InteguSeal for Surgical Skin Preparation in Patients Undergoing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- The primary endpoint of the study will be to determine the incidence of postoperative wound drainage during hospital stay when adding Integuseal to the normal surgical skin preparation.
研究概览
简要总结
This study is being conducted to investigate the potential benefits of using a special type of fluid that can be applied to the skin (Integuseal) in addition to standard surgical skin preparation in patients undergoing total hip replacement (THA) or total knee replacement (TKA). Integuseal is supposed to lock down the skin bacteria and reduce skin infection and other problems. This study will investigate whether Integuseal is effective in reducing persistent wound drainage when used in addition to standard surgical skin preparation for total hip arthroplasty (THA) or total knee replacement (TKA).
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are able and willing to provide informed consent;
- •Male and non-pregnant, non-lactating, female subjects who are willing to practice effective means of contraception or postmenopausal/surgically sterilized female subjects, between the ages of 18-80 years old, of any ethnic origin.
- •Subjects deemed able to comply with study schedule visits, procedures and medications as specified by the protocol.
- •Subjects undergoing elective THA or TKA procedures.
- •Subjects in satisfactory health as determined by the investigator on the basis of medical history and physical examination.
排除标准
- •Subjects undergoing revision, hemiarthroplasty, or bilateral THA or TKA
- •Subjects undergoing non-elective THA or TKA procedures.
- •Pregnant or lactating females or females of childbearing potential not practicing an effective method of contraception.
- •Subjects with known allergies to iodine and/or chlorhexidine
研究组 & 干预措施
1
干预措施: Integuseal (Device)
2
Standard Surgical skin preparation
结局指标
主要结局
The primary endpoint of the study will be to determine the incidence of postoperative wound drainage during hospital stay when adding Integuseal to the normal surgical skin preparation.
时间窗: Total joint replacement to discharge from hospital
次要结局
- To evaluate the effect of using Integuseal on the length of hospital stay after THA or TKA.(Total joint replacement to discharge from hospital)
- To evaluate the effect of using Integuseal on the incidence of surgical site infection (SSI).(6 weeks)
- To evaluate the effect of using Integuseal on the incidence of revision or re-admission after undergoing THA or TKA(6 weeks)