Prophylactic Muscle Flaps for the Prevention of Vascular Graft Infection After Groin Dissection
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Incidence of Graft Infection Requiring Re-operation
研究概览
简要总结
Previous studies have suggested that prophylactic muscle coverage in high-risk patients undergoing revascularization procedures through a groin incision have the potential to reduce rates of complications and re-operation. This is a prospective randomized control trial to test this hypothesis at the University of Wisconsin Hospitals and Clinics.
详细描述
The incidence of graft infections after groin dissection for lower limb revascularization is estimated to be between 2 and 20%. Infection requiring re-operation and muscle flap coverage for salvage is estimated to be between 11 and 13%. Retrospective studies have endeavored to create risk calculators to better predict patients at high risk of need for muscle flap salvage. Fischer et al. suggest that in high-risk patients, prophylactic muscle flaps can reduce complications from 70% to 10%, rates of infection from 70% to 3% and wound breakdown from 48% to 5%. Cost-savings of around $400,000 per year with the use of prophylactic muscle flaps are estimated. Unfortunately, the retrospective nature of the Fischer et al. study, lack of standardization of patients receiving prophylactic muscle flaps, and use of the same cohort for the risk calculator as for the outcomes analysis all reduce the generalizability and reproducibility of these results.
At the University of Wisconsin Hospitals and Clinics, muscle coverage is routinely used in cases of infection or lymph leak but is not systematically used in prophylactic settings. This is because it is generally left to surgeon preference-if they feel like a muscle flap is needed (for a variety of non-standardized anatomic/surgical or patient factors) then it is performed. Muscle coverage of vascular grafts in and of itself is not an experimental procedure and has been performed for decades.
The goal of this study is to determine whether prophylactic muscle flaps in high-risk patients can a) reduce the rates of infection requiring re-operation, and b) reduce the significant morbidity associated with other non-operative complications. This will be the first prospective, randomized control trial to address this issue.
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
- •Open lower extremity arterial revascularization
- •Groin incision
- •"High-risk" patients based on risk calculation
排除标准
- •Pregnant or breast-feeding
- •Any person with diagnosis of an active groin infection preoperatively
- •Incarcerated patients
- •Unstable patients going directly to the OR for whom the study consent process would delay care, and those who cannot give informed consent to participate in the research study will be excluded
- •If a surgeon feels that a patient should or should not receive a flap based on intra-operative or pre-operative characteristics, those patients will be excluded from the study
- •Prior to a scheduled groin intervention case a prior authorization will be sent to the participant's insurance company. If the groin flap is denied, which would be highly unusual, then the participant would be excluded from the study.
结局指标
主要结局
Incidence of Graft Infection Requiring Re-operation
时间窗: within 1 year
Infection of the vascular graft as determined by clinical diagnosis which requires re-operation for washout or other indicated procedures
次要结局
- Toronto Lower Extremity Salvage Score (TESS) at 12 months(12 months)
- Readmission rates(30- and 90-days)
- Incidence of Infection Not Requiring Re-operation(1 year)
- Incidence of Seroma(1 year)
- Incidence of Lymphocele(1 year)
- Toronto Lower Extremity Salvage Score (TESS) at 6 months(6 months)
- Number of clinic visits after index surgery(1 year)
- Death(1 year)
- Incidence of Wound Dehiscence(1year)
- Toronto Lower Extremity Salvage Score (TESS) at 3 months(3 months)
- Toronto Lower Extremity Salvage Score (TESS) at 9 months(9 months)
- Total cost of hospitalizations for index diagnosis(1 year)