Improvement in Wound Healing With Negative Pressure Wound Therapy for Postoperative Total Hip Arthroplasty
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
North Carolina
-
Chapel Hill、North Carolina、美国、27599
- UNC Orthopaedics
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adult patients undergoing primary total hip arthroplasty.
Exclusion Criteria:
- age less than 18 y/o
- Total hip arthroplasty for fracture
- Revision or conversion total hip arthroplasty
- inability to personally consent to participation due to cognitive impairment, intoxication or sedation
- multiple surgical procedures
- Patients taking immune modulating medication(prednisone, methotrexate, anakinra, etc.)
- skin hypersensitivity to acrylic adhesive or silver.
- Inability to care for dressing due to physical or mental incapacitation
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:PREVENA Group
Patients will be treated with the PREVENA negative pressure device following total hip arthroplasty.
This dressing will be used for a period of seven days.
|
The device is a sealed negative pressure wound therapy tool.
The device will be placed on the skin during surgery and left in place until their followup at 7 days.
其他名称:
|
无干预:Standard group
Patients will be treated with the standard absorptive dressing following total hip arthroplasty.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Mean Wound Healing Scores by the ASEPSIS Criteria
大体时间:(Single point evaluation)-2 weeks post surgery visit
|
A method of evaluating wounds for infection risk that incorporates multiple wound healing factors such as erythema, drainage, and dehiscence is the ASEPSIS (Additional treatment, presence of Serous discharge, Erythema, Purulent exudate, Separation of the deep tissue, Isolation of bacteria, and duration of inpatient Stay) wound scoring system.
Originally developed and validated for cardiac surgery sternal wounds, ASEPSIS evaluates the wound for the severity of multiple factors linked with surgical site infection.
This includes dehiscence, exudate/discharge, and erythema.
The higher the score, the more likely a surgical site infection will be present.
This score will give us a more diverse picture of postoperative wound healing and the influence of Negative Pressure Wound Therapy.
Scores can range from 0 to 65, with most scores expected at the lower scale.
|
(Single point evaluation)-2 weeks post surgery visit
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Number of Participants With Infection
大体时间:(Single point evaluation)-6 weeks post surgery visit
|
The investigators will continue to monitor the patients for development of an acute postoperative infection. A deep infection refers to an infection below the superficial soft tissue and likely involving the prosthesis. This will be evaluated by the musculoskeletal infection society consensus on total joint infection. Criteria include:(Either one major criteria or four minor criteria) Major criteria Sinus track communicating with the prosthesis Two separate cultures from the joint positive for the same organism Minor criteria Elevated erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) Elevated synovial leukocyte count Elevated synovial neutrophil percentage Purulent drainage from the joint One positive fluid culture from the joint Histological analysis of tissue showing more than 5 neutrophils per high power field in 5 fields |
(Single point evaluation)-6 weeks post surgery visit
|
合作者和调查者
调查人员
- 首席研究员:Daniel J Del Gaizo, MD、UNC Orthopaedics
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
PREVENA的临床试验
-
St. James's Hospital, Ireland尚未招聘
-
University of SaskatchewanKinetic Concepts, Inc.; Saskatoon Health Region完全的
-
3MKCI Europe Holding B.V.终止
-
3M终止伤口和伤害 | 关节疾病 | 肌肉骨骼疾病 | 关节痛 | 手术伤口 | 膝关节炎 | 腿部水肿 | 双侧全膝关节置换术美国
-
University of Calgary3M完全的