NCT03274466已完成不适用
Post-market, Randomized, Open-Label, Multicenter, Study to Evaluate the Effectiveness of Closed Incision Negative Pressure Therapy Versus Standard of Care Dressings in Reducing Surgical Site Complications in Subjects With Revision of a Failed Total Knee Arthroplasty (PROMISES)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KCI USA, Inc
- 入组人数
- 294
- 试验地点
- 29
- 主要终点
- Number of Participants With Surgical Site Complications (SSC)
研究概览
简要总结
This study evaluates surgical site complications in subjects undergoing revision of a total knee arthroplasty when closed incision negative pressure therapy is used to manage the closed incision, as compared to a standard of care dressing.
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
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-operative Inclusion Criteria:
- •The subject:
- •is at least 22 years of age on the date of informed consent
- •is able to provide their own informed consent
- •requires a TKA revision defined as one of the following:
- •a one-stage aseptic revision procedure
- •a one-stage septic exchange procedure (requiring removal of all hardware) for acute postoperative infection
- •removal of cement spacer and re-implantation procedure
- •open reduction and internal fixation of peri-prosthetic fractures
- •has one or more of the following:
- •a body mass index (BMI) greater than 35 kg/m2
- •a requirement for the use of blood thinners other than acetylsalicylic acid (ASA) after surgery
- •history of or current peripheral vascular disease
- •the presence of lymphedema in the operative limb
- •insulin-dependent diabetes mellitus
- •current tobacco use or previous history of smoking and quitting within the past 30 days
- •a history of prior infection of the operative site
- •current use of immunomodulators or steroids
- •current or history of cancer or hematological malignancy (excluding localized skin cancer)
- •rheumatoid arthritis
- •current renal failure or dialysis
- •malnutrition as determined by the investigator
- •liver disease as determined by the investigator
- •status post solid organ transplant
- •is willing and able to return for all scheduled study visits
- •if female, has a negative urine or serum pregnancy test at screening and day of revision surgery. Women who have had surgical sterilization by a medically accepted method such as tubal ligation, hysterectomy, or oophorectomy or are post-menopausal, defined as not having menstruation for >= 12 months will be excluded from requiring this test.
- •Intra-operative Inclusion Criteria:
- •The subject:
- •continues to meet all pre-operative inclusion criteria
- •has undergone a TKA revision resulting in a closed surgical incision
- •Pre-operative
排除标准
- •The subject:
- •is pregnant or lactating
- •will undergo a bilateral TKA within the same operative visit
- •will undergo a bilateral TKA in which the first TKA surgery is on the knee selected for study
- •will undergo a staged bilateral TKA in which the TKA revision surgery for the knee under study occurs within 30 days of the first TKA procedure
- •was previously randomized in this protocol
- •has a systemic active infection at the time of revision not including chronic viral infections such as HIV or hepatitis
- •has a remote-site skin infection at the time of revision
- •was tattooed on the area of the incision within 30 days prior to randomization
- •has known sensitivity to the study product components (drape and/or dressing materials in direct contact with the closed incision or skin)
- •has known sensitivity to silver
- •is currently enrolled in another investigational trial that requires additional interventions
- •is planned to be enrolled in another investigational trial that requires additional interventions at any time during the study
- •has localized skin cancer around the incision site
- •Intra-operative Exclusion Criteria:
- •The subject:
- •is found to meet any of the pre-operative exclusion criteria
- •has a surgical incision that precludes placement of dressing
- •has a TKA revision resulting in a muscle flap
- •has a TKA revision resulting in the placement of a spacer
- •has an incision drainage and debridement procedure only
- •has a surgical incision closed with skin glue
结局指标
主要结局
Number of Participants With Surgical Site Complications (SSC)
时间窗: within 90 days after TKA revision
The subject incidence of Investigator-assessed surgical site complications (SSCs) within 90 days of TKA revision. SSCs include any of the following: * Superficial Surgical Site Infection (SSI) * Deep SSI * Full thickness skin dehiscence * Seroma or hematoma requiring drainage or surgery * Skin necrosis * Continued drainage at the time of dressing removal
次要结局
- Number of Participants With Deep Surgical Site Infection(90 days after TKA revision)
- Number of Participants With Surgical Site Infection (SSI) (Superficial or Deep)(90 days after TKA revision)
研究者
研究点 (29)
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