Prospective Evaluation of Type IV Hypersensitivity Reactions After Aquacel 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
- 457
- 试验地点
- 1
- 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
The aim of this multi-surgeon, single institution study is to prospectively evaluate the incidence of allergic contact dermatitis (ACD) following application of AQUACEL Ag, a silver-containing hydrofiber dressing, in total hip and knee arthroplasty patients. Arthroplasty-naïve patients will be compared to prior total joint arthroplasty patients who received a Aquacel dressing postoperatively.
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.
Sample Size:
A power analysis to determine how many patients need to be enrolled was performed with a rate of ACD in the AQUACEL Ag naïve group and the AQAUCEL Ag-exposed group of 1% and 2%, respectively. A one-tailed z-test of proportions between the two groups with 80% power, a 5% level of significance, and 1:1 allocation ratio, requires a sample size of 314 (157 per group). To account for 20% attrition rate amongst both cohorts, we plan to enroll 400 patients (200 each group).
Demographic/Patient Specific Data Collected:
Age, Sex, Body Mass Index (BMI), Allergy History, Past Surgical History, Prior exposure to surgical dressing (Either occupational (i.e. healthcare worker) or as a patient), Number of prior arthroplasty surgeries with AQUACEL Ag dressing (i.e. 0, 1, 2, 3), Past adverse reaction to AQUACEL Ag dressing, Any Adverse Skin Reactions with any past adhesive exposure
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 hip arthroplasty (THA)
- •Patients older than 18 years that underwent primary total or unicompartmental knee arthroplasty (TKA/UKA)
排除标准
- •Revision surgery
- •Prior history of allergic contact dermatitis
- •Prior history of non-TJA or UKA surgery with AQUACEL Ag dressing post-op
- •Occupational exposure to surgical dressings
- •Documented history of silver allergy
研究组 & 干预措施
Prior Aquacel group
All subject's receive the Aquacel dressing, this group is comprised of patients who have undergone previous joint replacement surgery (hip or knee) and have had a Aquacel 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: Aquacel dressing (Device)
Arthroplasty-naïve Aquacel group
All subject's receive the same dressing, this group is comprised of patients consented to the study and will receive the Aquacel dressing but have not had previous joint replacement surgery. Therefore, we consider them the arthroplasty-naïve Aquacel group.
干预措施: Aquacel 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 2 Weeks Post Surgery
时间窗: 14 days post 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)
研究者
Vasili Karas
Assistant Professor, Orthopaedic Surgery Adult Reconstruction and Replacement
Rush University Medical Center