Prospective, Randomized Clinical Study to Evaluate the Efficacy of 2 Surgical Skin Preparations in Reducing Wound Drainage Following Total Joint Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- The primary objective of this study is to determine the rate of wound drainage following total joint arthroplasty (TJA) until discharge in both treatment groups
研究概览
简要总结
Surgical skin complications can be costly and could contribute to extended in-patient stay following total joint replacement or even the need for re-admission. If efficacy in reducing the incidence of post-operative wound drainage and, in turn, surgical wound complications can be demonstrated, it may also reduce the length of hospital stay and the need for revision surgery or readmission. The aim of this research is to investigate the incidence of post-operative wound drainage following elective total joint arthroplasty using two surgical skin preparation protocols.
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
- Quadruple (Participant, Care Provider, Investigator, 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, postmenopausal or surgically sterilized female subjects between the ages of 18-80 years old.
- •Subjects deemed able to comply with study visit schedule and procedures.
- •Subjects undergoing elective total hip arthroplasty or elective total knee arthroplasty.
排除标准
- •Subjects undergoing revision, unicompartmental, bilateral total knee arthroplasty or bilateral total hip arthroplasty.
- •Subjects undergoing non-elective total joint procedures.
- •Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception.
- •Subjects with known allergies or previous skin reaction to iodine povacrylex
研究组 & 干预措施
Standard Surgical Skin Preparation with Duraprep
standard surgical skin prep
干预措施: Duraprep Surgical Solution (Drug)
结局指标
主要结局
The primary objective of this study is to determine the rate of wound drainage following total joint arthroplasty (TJA) until discharge in both treatment groups
时间窗: Up to one year following surgery
Starting on post operative day 1 (the first day following surgery), at the time of the surgical dressings are removed and changed, assessments will be made to determine level of post-operative wound drainage following TJA.
次要结局
- The secondary objectives will focus on wound assessment and signs and symptoms of infection from TJA until discharge.(until hospital discharge)
- Length of hospital stay(until hospital discharge)
- Need for readmission or reoperation for up to 6 weeks following TJA(6 weeks post-op)
- Incidence of surgical skin infection at the first post-operative visit (6 weeks following surgery)(6 weeks post-op)
- Incidence of skin blistering.(up to one year post-op)
- Scar cosmesis at the first post-operative visit.(up to 6 weeks post-op)
研究者
Tiffany Morrison, MS
Manager, Clinical Trials, Rothman Institute
Rothman Institute Orthopaedics