Standard Versus Short Course Prophylactic Antibiotic in Femur and Tibia Shaft Fractures Managed With Intramedullary Interlocking Nail

NCT07554079 | Completed

• 1 other identifier: 43/24
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Fracture Femur; Antibiotic; Antibiotic Prescription; Surgical Site Infection (SSI); Fracture Tibia

Keywords

Antibiotic; Antimicrobial Stewardship; Orthopedics; Surgical Site Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard Course Antibiotics

ACTIVE COMPARATOR

Nine postoperative doses of cefuroxime 750 mg; each dose every eight hours for three days

Drug: Standard Course Antibiotics

Short Course Antibiotics

EXPERIMENTAL

Drug: Short Course Antibiotics

Interventions

Short Course Antibiotics DRUG

Three postoperative doses of cefuroxime 750 mg; each dose eight hours apart

Short Course Antibiotics

Standard Course Antibiotics DRUG

Nine postoperative doses of cefuroxime 750 mg; each dose eight hours apart

Standard Course Antibiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kathmandu University School of Medical Sciences: lead

Study Sites (1)

Dhulikhel Hospital, Kathmandu University Hospital

Dhulikhel, Bagmati, Nepal

Location

Related Publications (3)

• 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.

  PMID: 40416276 BACKGROUND

• 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.

  PMID: 30166239 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.

  PMID: 34723233 BACKGROUND

MeSH Terms

Conditions

Femoral Fractures; Tibial Fractures; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: February 15, 2024
• Primary Completion: November 8, 2025
• Study Completion: November 8, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

NE (1)