Prevena™ Incision Management System Versus Dermabond in the Prevention of Groin Wound Infections in Patients Undergoing Vascular Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 3
- 主要终点
- Comparison of Healing of Groin Wounds Between Patients Treated With Prevena vs Dermabond
研究概览
简要总结
This study evaluates the clinical efficacy and cost effectiveness of Prevena Incision Management System versus Dermabond in preventing groin wound infections in patients who undergo vascular surgery requiring a groin wound. Half of the patients will receive Dermabond and the other half will receive the Prevena Incision Management System for their groin wounds.
详细描述
Dermabond and the Prevena Incision Management System are both FDA approved wound care products. Prevena is a negative pressure system which holds the wound together and removes exudate and debris from the site to prevent infection. Dermabond is a surgical glue which holds the wound together to prevents infection. Prevena is more expensive to apply. However, the hypothesis is that the Prevena System will decrease infection rates and therefore, decrease the ultimate cost of the health care needed after surgery.
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
- •In need of elective vascular procedure requiring ≥8 cm groin incision.
- •Able to provide consent
- •Able to care for wound or have support person to complete wound care
- •Willing to comply with follow-up
排除标准
- 未提供
研究组 & 干预措施
Dermabond
Dermabond for vascular surgical groin wounds
干预措施: Dermabond (Device)
Prevena
Prevena Incision Management System for vascular surgical groin wounds
干预措施: Prevena Incision Management System (Device)
结局指标
主要结局
Comparison of Healing of Groin Wounds Between Patients Treated With Prevena vs Dermabond
时间窗: 30 days
The primary effectiveness endpoint is 30 day healing of the randomized groin incision, with any wound infection or failure to heal. Szilagyi wound infection grade quantified on an ordinal scale will be used to assess the healing (None, Grade I: Infection contained to the dermis, Grade II: Infection extending into the subcutaneous tissue but the arterial graft is not involved, Grade III: Infection of the arterial graft or native vessel underlying the incision). Healing is assessed by complete sealing of the incision with no residual separation or drainage. All of the incisions were primarily closed, so a healed incision would have no gaps between the skin edges. This is a visual inspection. Szilagi is an assessment of the grade of wound infection for those that did not heal. It is well recognized and published, and noted as above for patients with vascular exposure.
次要结局
- Number of Visiting Nurses Home Visits and Physician Office Visits to Assess/Treat Wound Infection(30 days)
- Cost of Care(30 days)
研究者
Linda Harris
Professor
State University of New York at Buffalo