Comparison of Negative Pressure Wound Therapy Versus Conventional Dressings for the Prevention of Wound Complications Following Revision Total Hip Arthroplasty: A Prospective, Randomized, Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- Wound complications
研究概览
简要总结
Wound complications and surgical site infections following revision total joint arthroplasty result in significant morbidity and cost. To the investigators knowledge, no prospective, randomized controlled trials have examined the rate of wound complications, infection, and reoperation following revision total hip arthroplasty when treated with negative pressure wound therapy (NPWT) versus sterile dressings. The investigators hypothesize that the rate of wound complications, infections, and subsequent procedures in patients undergoing revision THA treatment will demonstrate a statistically and clinically relevant decrease when using NPWT versus sterile dressing.
详细描述
Wound complications and surgical site infections (SSI) following revision total joint arthroplasty result in significant morbidity and cost. Persistent incisional drainage following total joint arthroplasty (TJA) has been reported to occur in 1% to 3% of patients. Drainage persisting greater than 48 hours has been reported as a risk factor for the development of an acute periprosthetic joint infection (PJI), with each additional day of wound drainage increasing the infection risk by 29-42%. Consequently, continued wound drainage has been shown to potentially increase the economic burden through longer hospital stays and subsequent surgical procedures. To the investigators knowledge, no prospective, randomized controlled trials have examined the rate of wound complications, infection, and reoperation following revision total hip arthroplasty when treated with NPWT versus sterile dressings. The investigators hypothesize that the rate of wound complications, infections, and subsequent procedures in patients undergoing revision THA treatment will demonstrate a statistically and clinically relevant decrease when using NPWT versus sterile dressing. The investigators will utilize a prospective, randomized, controlled study design to assess the efficacy of negative pressure wound therapy (NPWT) on the rate of wound complications, surgical site infections (SSIs), and reoperations after revision total hip arthroplasty (THA). For 90 days after surgery, the wound complications, including wound dehiscence, prolonged drainage for >7 days postoperatively, hematoma formation, surgical site infection, or periprosthetic joint infection that requires postoperative interventions, and reoperation will be tracked.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 > 18 years of age undergoing a revision total hip arthroplasty procedure to include:
- •Conversion of a prior open hip surgery (i.e. open reduction internal fixation of a proximal femur fracture) to a total hip arthroplasty
- •Aseptic revision for a diagnosis of component loosening, osteolysis, or revision procedure for periprosthetic fracture that requires revision of a component of the THA prosthesis (excluded isolated open reduction internal fixation of the fracture or initial placement of a hemi- or total hip arthroplasty)
- •Septic revision surgery including irrigation and debridement of a postoperative infection or hematoma, one-stage exchange for acute postoperative infection, explantation and placement of an antibiotic cement spacer
- •Reimplantation of a THA following placement of an antibiotic-loaded cement spacer
- •The incision can be closed primarily without muscle flaps or skin grafting
- •Willingness to undergo randomization and return for all scheduled visits
排除标准
- •Patients requiring a muscle flap or skin grafting for wound closure
- •Pregnant or lactating female
- •Known sensitivity to the study product components (adhesives, etc.)
- •Allergy to silver
结局指标
主要结局
Wound complications
时间窗: 90 days
Wound complications within 90 days of a revision total hip arthroplasty include: wound dehiscence, prolonged drainage for \>7 days postoperatively, hematoma formation, surgical site infection, or periprosthetic joint infection that requires postoperative interventions (i.e. unplanned office visits, topical application of antibiotics or PO antibiotics, in-office wound debridement or removal of suture material, hematoma aspiration and drainage) or a return to the operating room/reoperation.
次要结局
- Reoperation(90 days)
- Cost comparison(90 days)