Intranasal Povidone Iodine (PVI) to Prevent Staphylococcus Aureus Surgical Site Infections After Operative Procedures to Fix High-Energy Lower Extremity Fractures (POTENT Study)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
- 试验地点
- 6
- 主要终点
- Incidence of Complex (deep incisional or organ space) Staphylococcus aureus surgical site infection (SSI)
研究概览
简要总结
The purpose of this study is to see whether applying povidone iodine (PVI) to the noses of patients undergoing lower extremity (leg, ankle, or foot) orthopedic fixation procedures of high-energy lower extremity fractures (HELEF) will decrease the patients' risk of surgical site infections (SSI), particularly those caused by Staphylococcus aureus.
详细描述
These patients are at high risk of SSI but given the rapidity with which they need their operations, interventions that take time are difficult or impossible to use in this patient population. This study will involve identifying patients with HELEF and applying PVI to their nares within 60 minutes before their surgical incisions are made and again approximately 12 hours after the first dose. The investigators will abstract information from the patients' medical records about their demographics, underlying illnesses, injury severity, the surgical procedures, and SSI for the 6 months following their operations and the investigators will see them during their routinely scheduled visit at about 6 months to ask them whether they were treated for SSI by providers outside of our system. For patients who do not return for follow up, the investigators will try to contact them to determine if they had signs or symptoms of SSI or were treated for SSI outside of our system.
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
- •Age > 18 years of age.
- •Is undergoing one or more procedures to address the included fractures listed below for one or more (at least one) HELEF at high-risk for SSI:
- •Open tibia fractures
- •Open femur fractures
- •Open or closed tibial plateau fractures
- •Open or closed tibial pilon fractures
- •Open or closed calcaneus fractures
- •Open or closed talus fractures
- •Open or closed foot fractures of any bone EXCEPT the toes
- •Open fibula fractures
- •Open rotational ankle fractures (malleoli)
- •Open or closed leg fractures associated with compartment syndrome
- •Examples of included procedures:
- •Excisional debridement of open fracture, femur and/or tibia
- •Intramedullary nail, tibia (open injury)
- •Intramedullary nail, femur (open injury)
- •Open reduction Pilon/Plafond fracture
- •Open reduction tibial plateau fracture
- •Open reduction calcaneal fracture
- •Open reduction Lisfranc/metatarsal associated with crush injury
- •Open reduction talus
- •External fixation, lower extremity tibia or femur associated with open fracture or compartment syndrome
- •Fasciotomy, lower extremity for compartment syndrome related to femur, tibia, or foot fracture
- •Lower extremity amputation related to HELEF
排除标准
- •Documented or verbalized sensitivity or allergy to iodine or iodine-based contrast.
- •Known pregnancy in women.
- •Active bacterial infection at the HELEF site.
- •Incarcerated persons.
- •Persons who cannot follow up at the participating site (e.g., people who are homeless at the time of the injury or people with intellectual challenges who lack the social support for follow up visits).
- •Patients with facial fractures or other conditions that preclude nasal swabbing.
- •Patients who do not speak English or Spanish.
研究组 & 干预措施
Nasal Povidone-Iodine Decolonization Intervention
Intranasal povidone-iodine (PDI Profend) will be applied to the patients' noses 60 minutes before surgery to repair HELEF and approximately 12 hours after the first application. If the patient will have additional HELEF repair in the 6 month followup period, intranasal PVI will be applied in a similar manner for each procedure.
干预措施: povidone-iodine topical ointment (Drug)
Concurrent Control
Standard of Care. This will be usual care at each participating site for subjects enrolled in the Baseline period.
结局指标
主要结局
Incidence of Complex (deep incisional or organ space) Staphylococcus aureus surgical site infection (SSI)
时间窗: within 180 days of the initial surgical procedure for HELEF repair
Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN) definitions for SSI found in the "Surgical Site Infection Event (SSI)" guide at https://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf
次要结局
- Incidence of all Staphylococcus aureus SSI(within 180 days of the initial surgical procedure for HELEF repair)
- Incidence of all Complex SSI(within 180 days of the initial surgical procedure for HELEF repair)
- Incidence of all gram-negative Complex SSI(within 180 days of the initial surgical procedure for HELEF repair)
- Incidence of cellulitis involving the surgical site(within 180 days of the initial surgical procedure for HELEF repair)
- Clavien-Dindo assessment of postoperative complications scores(within 180 days of the initial surgical procedure for HELEF repair)
研究者
Loreen Herwaldt
Professor
University of Iowa