Pre-operative Alcohol Skin Solutions in Fractured Extremities
- Conditions
- Closed Lower Extremity FractureSurgical Site InfectionUnplanned Fracture-Related ReoperationOpen Appendicular FracturePelvic Fracture
- Interventions
- Drug: DuraPrepDrug: ChloraPrep
- Registration Number
- NCT03523962
- Lead Sponsor
- University of Maryland, Baltimore
- Brief Summary
The prevention of infection is an important goal influencing peri-operative care of extremity fracture patients. Standard practice in the operative management of extremity fractures includes sterile technique and pre-operative skin preparation with an antiseptic solution. The available solutions kill bacteria and decrease the quantity of native skin flora, thereby decreasing surgical site infection (SSI). While there is extensive guidance on specific procedures for prophylactic antibiotic use and standards for sterile technique, the evidence regarding the choice of antiseptic skin preparation solution is very limited for extremity fracture surgery.
- Detailed Description
More than one million Americans suffer an extremity fracture (broken bone in the arm, leg, or pelvis) that requires surgery each year. Approximately 5% (or 50,000) of surgical fracture patients develop a surgical site infection (SSI), which is twice the rate among most surgical patients and nearly five times the rate among patients undergoing elective orthopaedic surgeries (e.g. joint replacement). Patients who develop a SSI after their fracture fixation surgery experience a long and difficult treatment pathway. Researchers have identified that when a fracture patient experiences a SSI, they typically undergo at least two additional surgeries to control the infection, spend a median of 14 additional days in the hospital, and have significantly lower health related quality of life (HRQL). Similarly, results from the recently completed Fluid Lavage of Open Wounds (FLOW) trial confirmed that patients who had a SSI, or another complication, that required an additional surgery reported significantly lower physical and mental HRQL in the 12 months following their fracture compared to patients who did not experience a SSI. In the most severe cases, when a SSI cannot be controlled, a limb amputation becomes necessary.
Open fractures, closed lower extremity fractures, and pelvic fractures represent some of the most severe musculoskeletal injuries. Due to their high-energy mechanisms, these fractures are often accompanied by soft-tissue injuries that contribute to unacceptably poor outcomes. The FLOW trial of 2,447 open fracture patients reported a 13.2% incidence of open fracture-related reoperations; Closed fractures of the lower extremity are also at high risk of complications, particularly when compared to closed upper extremity fractures. For example, the rate of SSI in closed tibial plateau and plafond fractures range from 5.6 - 11.9%, although some cohort studies have reported infection rates as high as 25.0%. This is contrast with SSI rates of \<5% for common upper extremity fractures like humeral shaft, forearm, or distal radius fractures. This is further illustrated in a series of 214 deep orthopaedic fracture infections, in which 58% occurred in the tibia and ankle, and only 10% occurred anywhere in the upper extremity. Finally, pelvic fractures are associated with some of the most challenging SSIs to treat among closed fractures because of their propensity to gram negative organisms and limitations in reconstruction options post-infection. Ultimately, infectious complications in these fracture populations lead to prolonged morbidity, loss of function, and potential limb loss.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8485
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description First pre-op antiseptic skin solution DuraPrep The PREPARE trial will compare the most common alcohol-based pre-operative antiseptic skin solutions used during extremity fracture surgery. Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all eligible fracture surgeries for a two-month period. First pre-op antiseptic skin solution ChloraPrep The PREPARE trial will compare the most common alcohol-based pre-operative antiseptic skin solutions used during extremity fracture surgery. Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all eligible fracture surgeries for a two-month period. Crossover - Second pre-op antiseptic skin solution ChloraPrep Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all eligible fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase. Crossover - Second pre-op antiseptic skin solution DuraPrep Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all eligible fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase.
- Primary Outcome Measures
Name Time Method Number of Participants With a Superficial Incisional Surgical Site Infection (SSI) Within 30 days of the patient's last planned fracture management surgery Guided by the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network reporting criteria (2017):
Date of event for infection may occur from the date of fracture to 30 days after the definitive fracture management surgery; AND involves only skin and subcutaneous tissue of the incision; AND patient has at least one of the following:
1. purulent drainage from the superficial incision.
2. organisms identified from an aseptically obtained specimen from the superficial incision or subcutaneous tissue by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment
3. superficial incision that is deliberately opened by a surgeon, and culture or non-culture-based testing is not performed. AND patient has at least one of the following signs or symptoms: pain or tenderness; localized swelling; erythema; or heat.
4. diagnosis of a superficial incisional SSI by the surgeon.Number of Participants With a Deep Incisional Infection Within 90 days of the patient's last planned fracture management surgery Guided by CDC's National Healthcare Safety Network Surgical Site Infection reporting criteria (2017):
Deep Incisional Infection:
Occurs within 90 days post definitive fracture management; \& involves fascial/muscle layers; \& has at least one of the following:
1. deep incision purulent drainage
2. a deep incision that dehisces, or is opened by a surgeon, and organism is identified by microbiologic testing; or microbiologic testing is not performed \& has at least one of the following: fever (\> 38 °C); localized pain or tenderness
3. other evidence of deep incision infection on anatomical exam or imaging test
- Secondary Outcome Measures
Name Time Method Number of Participants With an Unplanned Fracture-Related Reoperation Within 12 months of the patient's last planned operation Common examples include any unplanned fracture-related surgery that is associated with an infection at the operative site or contiguous to it, a wound-healing problem, or a fracture delayed union or non-union.
Trial Locations
- Locations (27)
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
University of Maryland, R Adams Cowley Shock Trauma Center
🇺🇸Baltimore, Maryland, United States
University of California, Irvine
🇺🇸Irvine, California, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Case Western / MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Cedars Sinai
🇺🇸Los Angeles, California, United States
Regional Medical Center of San Jose
🇺🇸San Jose, California, United States
Louisiana State University
🇺🇸Baton Rouge, Louisiana, United States
University of Maryland Capital Region Health
🇺🇸Cheverly, Maryland, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Carolinas Medical Center, Atrium Health Musculoskeletal Institute
🇺🇸Charlotte, North Carolina, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Bryan Health
🇺🇸Lincoln, Nebraska, United States
Greenville Health System
🇺🇸Greenville, South Carolina, United States
Sanford Health
🇺🇸Sioux Falls, South Dakota, United States
Inova Health System Foundation / Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
Royal Columbia Hospital
🇨🇦New Westminster, British Columbia, Canada
McMaster University, Center for Evidence-Based Orthopaedics
🇨🇦Hamilton, Ontario, Canada
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Dartmouth-Hitchcock Medical Center
🇺🇸Hanover, New Hampshire, United States
Indiana University Health Methodist Hospital
🇺🇸Indianapolis, Indiana, United States
Duke University Hospital
🇺🇸Durham, North Carolina, United States
Wake Forest Baptist University Medical Center
🇺🇸Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
San Antonio Military Medical Center
🇺🇸San Antonio, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States