Evaluation of the Efficacy of Negative Pressure Wound Therapy on Incisional Wound Healing After a Total Ankle Arthroplasty: a Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Number of days from suture removal (i.e. day 21 after surgery) to achieve complete wound healing defined as: no visible exudate on protection dressing; and no blister; and no necrosis; and no wound dehiscence.
研究概览
简要总结
About 500 total ankle prostheses are implanted each year in France. Wound healing issues are the most common complications after Total Ankle Arthroplasty (TAA). In 2010, a French retrospective study observed a wound infection rate of 8% among 592 prostheses implanted. Wound infection rate can vary up to 28% from the data available in the literature. Delayed wound healing is a known risk factor of surgical site infection (SSI). Even if it remains a rare event, its consequences for the patient can be severe and lead to removal and/or replacement of the prosthesis, arthrodesis, or transtibial amputation.
Negative Pressure Wound Therapy (NPWT) is an adjuvant therapy for wound management and healing: it delivers a controlled negative pressure (sub-atmospheric) applied topically onto the wound from a vacuum pump. The wound is filled with wound filler and sealed with an airtight adhesive drape. It allows creating a moist wound environment, removing exudate, and reducing edema and risk of infection.
Incisional NPWT can accelerate wound healing regardless of the surgery performed, including orthopedics. A retrospective study compared the incidence of healing complications after TAA between the administration of the NPWT PICO™ (Smith&Nephew) and the standard of care of postoperative wounds in 74 patients. A significant reduction of wound healing issues (3% vs. 24%, respectively; p=0.004) and a non-significant reduction of SSI (3% vs. 8%, respectively) were observed.
To the investigator knowledge, no randomized study has been conducted to assess the efficacy of the NPWT PICO™ for postoperative wound healing after TAA: Investigators propose to set up this study to obtain a high level of evidence in this population and investigators assume that the use of the PICO™ system after TAA would reduce delayed wound healing compared to the standard of care with conventional dressings.
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
- 否
入选标准
- •Patient aged 18 years or older
- •Patient for whom a total ankle arthroplasty has been scheduled
- •Patient affiliated to a national health insurance scheme or similar
- •Patient who have signed an informed consent form for its participation in the study
排除标准
- •Patient with contraindication to use of the PICO™ device
- •Patient participating in another study including an exclusion period in progress
- •Patient participating in another interventional study that may interfere with this research
- •Adult patient protected by law, under guardianship or tutorship ;
- •Pregnant or breastfeeding women.
结局指标
主要结局
Number of days from suture removal (i.e. day 21 after surgery) to achieve complete wound healing defined as: no visible exudate on protection dressing; and no blister; and no necrosis; and no wound dehiscence.
时间窗: Up to 12 months after TAA
次要结局
- Rate of surgical revision for wound healing complications defined by: mechanical debridement; surgical debridement; flap surgery and skin graft.(Baseline to postoperative month 12.)
- Rate of surgical site infection (superficial, deep or of a surgical site other than the incision site).(postoperative day 30 to postoperative month 12.)
- Rate of wound healing complications: presence of exudate; blister; necrosis; wound dehiscence.(postoperative day 21, postoperative week 6, postoperative months 4 and 12.)
- Rate of technical failures of the PICO™ device, and type of failure: device failure, non-hermetic dressing, other.(baseline to postoperative day 7)
- Number and type of adverse effects related to the PICO™ device.(baseline to postoperative day 7)
- Incremental Cost-Effectiveness Ratio (ICER) between the two dressing strategies.(Up to 12 months after TAA.)