Standard Versus Short Course Prophylactic Antibiotic in Femur and Tibia Shaft Fractures Managed W… (NCT07554079) | Clinical Trial Compass
CompletedNot Applicable
Standard Versus Short Course Prophylactic Antibiotic in Femur and Tibia Shaft Fractures Managed With Intramedullary Interlocking Nail
Nepal56 participantsStarted 2024-02-15
Plain-language summary
Long-bone fractures, particularly of femur and tibia, are common following fall injury and road traffic accidents.1,2 The standard treatment is "intramedullary nailing," where a metal rod is inserted into the center of the bone to hold it in place.3,4 However, surgical site infection (SSI) and fracture related infection (FRI) remain significant complications of nailing that delay healing and increase healthcare costs.5,6
To prevent these infections, doctors give patients antibiotics around the time of surgery. However, there is ongoing debate about how long these antibiotics should be continued. In many regions, patients receive antibiotics for several days, but recent evidence suggests that a shorter course may be just as effective and could reduce the risk of antibiotic resistance and side effects.
Study Question The goal of this study is to determine if a one-day (short) course of antibiotics is as effective as a three-day (standard) course in preventing infections after bone-nailing surgery.
Hypotheses Null Hypothesis (H0): There is no significant difference in the incidence of infection or short-term clinical outcomes between the one-day (short-course) and three-day (standard-course) antibiotic protocols.
Alternative Hypothesis (H1): There is a significant difference in the incidence of infection or short-term clinical outcomes between the one-day (short-course) and three-day (standard-course) antibiotic protocols.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patients (≥18 years)
* Diaphyseal fractures of the femur (AO 32) or tibia (AO 42), including closed injuries and Gustilo-Anderson type I open fractures, who were scheduled for intramedullary interlocking nailing
Exclusion Criteria:
* Polytrauma
* Open fractures classified as Gustilo-Anderson type II or III
* Procedures other than intramedullary nailing
* Pregnancy
* Comorbidities known to affect infection risk, such as diabetes mellitus, immunocompromised states, chronic steroid use, active skin or chest infections, or other conditions requiring alternative antibiotic regimens
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared standard versus short-course antibiotics after intramedullary nail surgery for femur or tibia fractures — if I need this type of surgery, which antibiotic duration approach would you recommend for me, and why?
2The trial measured wound infection rates using something called the ASEPSIS score — can you explain what that scoring system looks for, and how you would monitor me for surgical site infection after my fracture repair?
3Since this trial is already completed, have the results been published yet, and if so, did one antibiotic regimen show a meaningful difference in infection rates that would influence my care?
4This study was categorized as Phase NA, meaning it wasn't testing a new drug but comparing existing antibiotic practices — does that mean both approaches in the study are already considered standard care, and which one is currently used at your hospital?
5Given that surgical site infection was the main concern being studied, what factors specific to my fracture — like whether it's open or closed, or my overall health — would most affect my infection risk and the antibiotic plan you'd choose for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Wound Infection based on ASEPSIS score
Timeframe: From enrollment to the end of postoperative follow up at six week
Trial details
NCT IDNCT07554079
SponsorKathmandu University School of Medical Sciences