Volume Reduction for Open Fracture Irrigation: A Randomized Prospective Feasibility Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of Surgical Site Infection (SSI) following irrigation and debridement of open fractures.
研究概览
简要总结
The purpose of this study is to help doctors who treat open fractures understand how much fluid is required when cleaning out the wound. Participants will spend about 12 months in this study and will be asked to answer study questions about your recovery at your typical follow up clinic visits with your surgeon. After the surgeon has determined a participant's bone has healed, any remaining study visits can be conducted over the phone, email, and/or mail. Participants will not be asked to attend additional clinic visits as part of this study. Researchers will compare two different fluid volume protocols to determine if one results in better fracture and/or wound healing.
详细描述
This study compares the two irrigation protocols for Irrigation and Debridement (I&D) of open fractures. Open fractures are classified using the Gustilo-Anderson classification criteria, which divides these fractures into Types I, II, and III. The study protocols being compared differ in the volume of normal sterile saline used during the I&D procedure. Protocol A sets the volume of irrigation to be 1L normal sterile saline for Type I and Type II open fractures and 3L for Type III open fractures. Protocol B uses 3L normal saline for Type I open fractures, 6L for Type II, and 9L for Type III. Irrigation volumes for Protocol A are based on current practice by orthopedic trauma surgeons at Inova. Volumes in Protocol B are based on the FLOW trial study design.
Hypothesis
Decreased irrigation volumes (Protocol A) during surgical I&D will be non-inferior to high irrigation volumes (Protocol B) with respect to the development of surgical site infection.
Study Design: This is a bimonthly cluster randomized trial in which the study. When enrollment begins, the first two-month (60-day) period will be randomly assigned to either Protocol A or B. Thereafter, the study treatment in effect allocation will alternate every two months (60 days). Since investigators will need this information to conduct the study treatment they cannot be blinded to treatment assignments.
This study design is based on the PREP-IT and PREPARE trials, which were national, multicenter RCTs that compared post-surgical infection rates after using different skin sterilization solutions to prepare surgical sites of open and closed fractures.
Patients will receive the protocol in effect at the time they consent to participate in the study, prior to their I&D, unless otherwise clinically indicated by their study surgeon while in the operating room (OR). All open fracture patients will be screened for participation in the study during their initial evaluation and admission to the hospital, based on inclusion and exclusion criteria detailed in the study protocol. A member of the study team will discuss the study with patients meeting the appropriate criteria prior to their first I&D. These patients will either be consented/enrolled or will be screen failed due to lack of consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 or older
- •Patient diagnosed with a Type I, II, or III open fracture of the appendicular skeleton by a study surgeon
- •For the purposes of this study, an open fracture is a fracture associated with a soft tissue wound which may or may not be contiguous with the fracture.
- •Open fractures of the carpals, tarsals, metacarpals, metatarsal, and/or phalanges without the involvement of a long bone or the hindfoot will not be considered.
排除标准
- •Patient is unable to understand Informed Consent and/or HIPAA Authorization Form
- •Patient does not speak English
- •Patient is pregnant
- •Patient is unable or (in the judgment of research personnel) unlikely to attend follow-up visits.
- •Patient was previously enrolled in a study which has the same primary outcomes or may influence infection rate or bone healing
- •Patient declines to participate in study
研究组 & 干预措施
Irrigation Protocol A
Protocol A sets the volume of irrigation as 1 liter normal sterile saline (0.9% sodium chloride) for Type I and Type II open fractures and 3 liters for Type III open fractures. Open fracture type is determined by the study surgeon in the operating room (OR).
干预措施: 0.9% Sodium Chloride (Drug)
Irrigation Protocol B
Protocol B sets irrigation volumes as 3 liters normal sterile saline (0.9% sodium chloride) for Type I open fractures, 6 liters for Type II, and 9 liters for Type III. The fracture type is determined by the study surgeon in the operating room (OR).
干预措施: 0.9% Sodium Chloride (Drug)
结局指标
主要结局
Incidence of Surgical Site Infection (SSI) following irrigation and debridement of open fractures.
时间窗: 90 days after first irrigation and debridement conducted in the operating room
Surgical site infection within 90 days of I\&D, per CDC definition. The site of interest for this study is the wound created by the fracture mechanism and the debridement thereof. It does not refer to incisions required solely for fixation.
次要结局
未报告次要终点