One-stage Versus Two-stage Surgical Treatment of Infectious Bursitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 2
- 主要终点
- Overall Costs of the Combined Surgical and Medical Treatment
研究概览
简要总结
The study investigates prospectively the cost-savings related to a one-stage bursectomy (debridement, drainage and closure at the same time) versus two-stage bursectomy (debridement, left open and closure at a second time) of severe bursitis among hospitalized patients for surgical treatment of septic bursitis.
We suppose that the one-stage bursectomy reveals similar recurrence rates but is associated with a significant shortening of hospital stay, consumption of resources and increased patient satisfaction.
详细描述
Start as single center interventional study at Geneva University Hospitals Study open for additional centres (electronic CRF) Funding on 24.6.2011 (50,000 Swiss Francs). Further demand for funding ongoing.
Septic bursitis of knee and elbows, for which the patients are hospitalised (a substantial part of patient with failure of conservative treatment) Randomisation 1:1 (one-stage vs. two-stage).
Duration of concomitant postsurgical antibiotic therapy fixed to 7 days Exclusion of severely immuno-depressed patients.
Assessment of all costs of inpatient treatment and outpatient follow-up of included cases.
Interim analysis after ca. 100 cases planified.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 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
- •Age >18 years
- •Hospitalized for bursectomy for septic bursitis
排除标准
- •Bacteraemic diseases
- •Presence of another concomitant infection requiring antibiotics
- •Presence of osteosynthesis material beneath the bursitis
- •Septic bursitis outside of the elbow or the knee
- •Severe immune suppression (transplantation, HIV with Cluster of Differentiation cell count <200 cells/mm3, immune suppressive treatment with equivalence of more than 15 mg of prednisone daily ).
- •Recurrent septic bursitis episodes
结局指标
主要结局
Overall Costs of the Combined Surgical and Medical Treatment
时间窗: 2 months
The overall costs are of primary interest in the study protocol.
次要结局
- Number of Participants With Post-surgical Wound Dehiscence(2 months)
研究者
Ilker Uckay
PD Dr. med, MD, Attending
University Hospital, Geneva