Prospective Evaluation of Type IV Hypersensitivity Reactions After Prineo Dressing Application in Partial and Total Joint Arthroplasty Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 303
- 试验地点
- 2
- 主要终点
- Rate of contact allergic dermatitis or adverse skin reaction at 2-3 weeks post surgery
研究概览
简要总结
Wound complications can be devastating following total joint arthroplasty, resulting in an increased practice burden in the form of more frequent follow ups, increased clinic visits potential for wound dehiscence, superficial infection and deep infection with possible return to the operating room and revision surgery. Several dressing options are currently on the market designed to minimize wound complications in addition to traditional dressings, including negative pressure dressing, antimicrobial dressing, occlusive dressings, and/or skin adhesives. Prineo dressing (2-octyl cyanoacrylate adhesive (Dermabond) and n-butyl-2-cyanoacrylate adhesive) has increased in popularity as a dressing option used by joint arthroplasty surgeons. There is a well-documented adverse allergic response with these dressings resulting in peri-incisional erythema, urticaria, and/or an eczematous skin reaction. Recently, Mayman et al reported a rate of 1-1.5%, suggesting a possible rising incidence of ACD attributable to increased utilization of the specific dressing and sensitization.
To our knowledge, no prospective trial has compared the rates of adverse allergic reactions in Prineo naive patients to patients who have undergone previous total joint arthroplasty (TJA) and received Prineo dressings in the past. The study team will utilize a prospective controlled study design to assess the rate of adverse allergic reactions in patients naive to Prineo versus those with previous exposure. The study team will assess rates of allergic reactions at one week post-op and at their first post-op clinic visit, 2 to 3 weeks post-op, tracking rates of allergic reactions as well as severity, the use of post-operative antibiotics, work up for prosthetic joint infection, return to the operating room, surgical site infection, confirmed prosthetic joint infection and stiffness requiring manipulation under anesthesia.
详细描述
Level I: Prospective Cohort Study
Patients will be recruited into the study after completing a standard questionnaire for pre-operative enrollment. After meeting inclusion criteria and passing the screening process, the patient will be enrolled into the study. Variables of interest related to sociodemographic status, operative details and postoperative outcomes will be taken from the electronic medical records associated with Midwest Orthopedics at Rush and Rush University Medical Center will be performed. This review will comprise patients of multiple providers at Midwest Orthopedics at Rush, including Dr. Vasili Karas, Dr. Richard Berger and Dr. Brett Levine. Relevant variables that will be collected include:
Inclusion Criteria:
- Patients older than 18 years that underwent primary total hip arthroplasty (THA)
- Patients older than 18 years that underwent primary total or unicompartmental knee arthroplasty (TKA/UKA)
Exclusion Criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Patients older than 18 years that underwent primary total joint arthroplasty (total hip, total knee, partial knee)
排除标准
- •Revision surgery
- •Prior history of allergic contact dermatitis
研究组 & 干预措施
Prineo naive group
All subject's receive the same dressing, this group is comprised of patients consented to the study and will receive the Prineo dressing but have not had previous joint replacement surgery. Therefore, we consider them Prineo-naive.
干预措施: Prineo dressing (Device)
Prineo-exposed group
All subject's receive the Prineo dressing, this group is comprised of patients who have undergone previous joint replacement surgery (hip or knee) and have had a prineo dressing. This also includes patients who have had prior exposure to glue/mesh dressing either as a patient or healthcare worker.
干预措施: Prineo dressing (Device)
结局指标
主要结局
Rate of contact allergic dermatitis or adverse skin reaction at 2-3 weeks post surgery
时间窗: 2-3 weeks following surgery
Using a classification of skin reactions from mild, moderate to severe
Rate of contact allergic dermatitis or adverse skin reaction at 1 week post surgery
时间窗: 7 days post surgery
Using a classification of skin reactions from mild, moderate to severe
Number of Participants With Contact Allergic Dermatitis or Adverse Skin Reaction at 1 Week Post Surgery
时间窗: 7 days post surgery
Using a classification of skin reactions from mild, moderate to severe- Rate of contact allergic dermatitis or adverse skin reaction at 1 week post surgery
Rate of Contact Allergic Dermatitis or Adverse Skin 2-3 Weeks Following Surgery
时间窗: Rate of contact allergic dermatitis or adverse skin 2-3 weeks following surgery
Using a classification of skin reactions from mild, moderate to severe
次要结局
- Wound complications (if applicable)(2-3 weeks after surgery)
- Number of Participants With Post Operative Complications(90 days post surgery)
研究者
Vasili Karas
Assistant Professor, Orthopaedic Surgery Adult Reconstruction and Replacement
Rush University Medical Center