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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Course Antibiotics | Active Comparator | Nine postoperative doses of cefuroxime 750 mg; each dose every eight hours for three days |
|
| Short Course Antibiotics | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short Course Antibiotics | Drug | Three postoperative doses of cefuroxime 750 mg; each dose eight hours apart |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Wound Infection based on ASEPSIS score | 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. | From enrollment to the end of postoperative follow up at six week |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dhulikhel Hospital, Kathmandu University Hospital | Dhulikhel | Bagmati | Nepal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40416276 | Background | Rodrigues FL, Ferrari ALM, Faria FF, Pinto RLE, Lopes MF, Santos MEA, Varela EC, Lopes Filho MJ, Cecyn MN, De Oliveira NHC. Epidemiology and Outcomes of Intramedullary Nailing for Tibial Diaphyseal Fractures: A Retrospective Multicenter Cohort Study. Cureus. 2025 Apr 24;17(4):e82894. doi: 10.7759/cureus.82894. eCollection 2025 Apr. | |
| 30166239 |
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| Standard Course Antibiotics | Drug | Nine postoperative doses of cefuroxime 750 mg; each dose eight hours apart |
|
| Saleeb H, Tosounidis T, Papakostidis C, Giannoudis PV. Incidence of deep infection, union and malunion for open diaphyseal femoral shaft fractures treated with IM nailing: A systematic review. Surgeon. 2019 Oct;17(5):257-269. doi: 10.1016/j.surge.2018.08.003. Epub 2018 Aug 27. |
| 34723233 | Background | GBD 2019 Fracture Collaborators. Global, regional, and national burden of bone fractures in 204 countries and territories, 1990-2019: a systematic analysis from the Global Burden of Disease Study 2019. Lancet Healthy Longev. 2021 Sep;2(9):e580-e592. doi: 10.1016/S2666-7568(21)00172-0. |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D013978 | Tibial Fractures |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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