Suprafascial Vancomycin Powder for Prevention of Surgical Site Infections After Instrumented Posterior Spinal Fusion
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 450
- 试验地点
- 13
- 主要终点
- Rate of superficial and deep SSIs (according to CDC criteria)
研究概览
简要总结
Surgical site infections (SSI) after spine surgery may occur in up to 12% of cases and can lead to increased morbidity, and healthcare costs In this randomized controlled trial the investigators aim to prospectively investigate the efficacy and safety of suprafascial intrawound vancomycin powder in reducing the rate of SSIs after instrumented spinal fusion surgery. Secondary aims of the study are the incidence of vancomycin-related complications, vancomycin-resistant bacterial infections in the treatment arm as well as the rate of revision surgeries due to SSIs.
详细描述
Background:
Surgical site infections (SSI) after spine surgery may occur in up to 12% of cases and can lead to increased morbidity, and healthcare costs. Numerous retrospective studies suggest the use of intrawound (subfascial) vancomycin powder in spine surgery to be protective against SSIs. Adverse events, such as seroma formation or neurotoxicity may be associated with the subfascial use of vancomycin powder in high doses in direct proximity to exposed neural structures. Only one retrospective study investigated the use of suprafascial vancomycin powder. The use of intrawound vancomycin powder is controversial and there is a paucity of well-designed prospective trials evaluating its efficacy and safety in spine surgery.
Objective:
The main objective of this Trial is to evaluate the efficacy and safety of suprafascially applied vancomycin powder in open instrumented spine surgery to prevent surgical site infections and inform a future phase-III trial.
Methods:
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
- Single (Participant)
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
- •Patients ≥ 18 years of age requiring open instrumented dorsal spinal fusion of at least 1 level (involving two adjacent vertebras and one intervertebral disc)
- •Signed informed consent
排除标准
- •Preoperative ongoing infectious disease present as judged by primary surgeon (based on lab results and clinical assessment);
- •Previous spine surgery at index level within last 90 days;
- •Known allergy to vancomycin;
- •Percutaneous or transmuscular instrumentation (minimally-invasive surgery) only without lumbar interbody fusion;
- •Postoperative radiotherapy of surgical site required (e.g. for tumor)
- •Preexisting cochlea damage OR known history of hearing loss NOT clearly associated with age-related hearing impairment (presbycusis);
- •Renal insufficiency with stage 4 chronic kidney disease (CKD) with a glomerular filtration rate (GFR) of 15-30 ml/min or worse;
- •Pregnancy or breastfeeding women;
- •Participation in other ongoing clinical trials;
- •Patients lacking capacity to consent;
研究组 & 干预措施
Control Arm
The control group receiving only a standard preoperative antimicrobial prophylaxis administered intravenously.
Treatment Arm
The powdered vancomycin will be placed subcutaneously over the closed muscle fascia (suprafascially) at the end of the surgery during wound closure.
干预措施: Vancomycin (Drug)
结局指标
主要结局
Rate of superficial and deep SSIs (according to CDC criteria)
时间窗: within 90 days following index surgery
次要结局
- Rate of vancomycin-resistant bacterial infections in the treatment group(within 90 days following index surgery)
- Cost of treatment for cost analysis between both treatment arms(1 year after index surgery)
- numeric rating scale (NRS) to assess pain intensity self-reported by the patient (Score 0-10 with 0 representing no pain, and 10 maximum pain intensity) at Visits 3, 4, 5 and 6 for neck or back pain depending on surgical level (cervical or lumbosacral)(day 4, day 5, day 42, day 90)
- Rate of bony fusion at the level of index surgery as assessed by CT(1 year after index surgery)
- Rate of revision surgery due to SSIs(within 90 days following index surgery)
- Rate of wound seromas(within 90 days following index surgery)
- Quality of life (EuroQoL 5D-5L), Mobility, Self-Care, Usual Activities, Pain/Discomfort, Anxiety/ Depression (rating from no problems to extreme problems) and health status self rating by patient (Score 0-100, 0 the worst health and 100 the best health)(day 42 and day 90)
- Rate of vancomycin-related adverse events both locally and systemically(within 90 days following index surgery)
- Rate of wound healing disorders without SSI within(within 90 days following index surgery)
- numeric rating scale (NRS) to assess pain intensity self-reported by the patient (Score 0-10 with 0 representing no pain, and 10 maximum pain intensity) at Visits 3, 4, 5 and 6 for leg or arm pain (cervical or lumbosacral)(day 4, day 5, day 42, day 90)
- Length of hospital stay(within 90 days following index surgery)