Antibiotic, Antibiotic Prescription, Fracture Femur, Fracture Tibia, Surgical Site Infection (SSI)
Conditions
Keywords
Antibiotic, Antimicrobial Stewardship, Orthopedics, Surgical Site Infection
Brief 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.
Interventions
Three postoperative doses of cefuroxime 750 mg; each dose eight hours apart
DRUGStandard Course Antibiotics
Nine postoperative doses of cefuroxime 750 mg; each dose eight hours apart
Sponsors
Kathmandu University School of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Wound Infection based on ASEPSIS score | From enrollment to the end of postoperative follow up at six week | The primary outcome is the rate of wound infection as categorized by the ASEPSIS scoring system. The ASEPSIS score is a validated tool that evaluates wound healing based on clinical criteria (Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and Stay as inpatient). Satisfactory Healing: Score 0-10 Disturbance in Healing: Score 11-20 Infection: Score \>20 The primary comparison will be the proportion of patients in each group reaching the "Wound Infection" category. |
Countries
Nepal
Outcome results
None listed