Fracture FemurNCT07554079
Standard Versus Short Course Prophylactic Antibiotic in Femur and Tibia Shaft Fractures Managed With Intramedullary Interlocking Nail
A study testing Short Course Antibiotics and Standard Course Antibiotics in people with Fracture Femur and Fracture Tibia, run by Kathmandu University School of Medical Sciences at 1 site in Nepal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture Femur, Fracture Tibia, Surgical Site Infection (SSI)
- What is being tested?
- Short Course Antibiotics and Standard Course Antibiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteNepal
- Study dates
- 15 Feb 2024to 8 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Nepal1 site
Dhulikhel Hospital, Kathmandu University Hospital
Dhulikhel, Bagmati
About this study
Official title: Standard Versus Short Course Prophylactic Antibiotic in Femur and Tibia Shaft Fractures Managed With Intramedullary Interlocking Nail: A Prospective Randomized Comparative Study Using the ASEPSIS Score
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.
Read more
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, Fracture Tibia, Surgical Site Infection (SSI), Antibiotic, Antibiotic Prescription
- Being tested
- Short Course Antibiotics, Standard Course Antibiotics
- Keywords
- Antibiotic, Antimicrobial Stewardship, Orthopedics, Surgical Site Infection
- Medical subject headings
- Femoral Fractures, Tibial Fractures, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short Course AntibioticsDrug
Three postoperative doses of cefuroxime 750 mg; each dose eight hours apart
Standard Course AntibioticsDrug
Nine postoperative doses of cefuroxime 750 mg; each dose eight hours apart
| Study group | Role | What they receive |
|---|---|---|
| Standard Course Antibiotics | Active comparator | Nine postoperative doses of cefuroxime 750 mg; each dose every eight hours for three days Receives: Drug: Standard Course Antibiotics |
| Short Course Antibiotics | Experimental | Not described Receives: Drug: Short Course Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of postoperative follow up at six week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start15 Feb 2024
- Primary completion8 Nov 2025
- Study completion8 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fracture FemurStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathmandu University School of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rohit Shrestha, Kathmandu University School of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554079
- Sponsor's protocol ID
- 43/24
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40416276Saleeb 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.
PubMed 30166239GBD 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.
PubMed 34723233
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Versus Short Course Prophylactic Antibiotic in Femur and Tibia Shaft Fractures Managed With Intramedullary Interlocking Nail: A Prospective Randomized Comparative Study Using the ASEPSIS Score
- ClinicalTrials.gov ID
- NCT07554079
- Acronym / sponsor ID
- 43/24
- Conditions
- Fracture Femur, Fracture Tibia, Surgical Site Infection (SSI), Antibiotic, Antibiotic Prescription
- Keywords
- Antibiotic, Antimicrobial Stewardship, Orthopedics, Surgical Site Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Kathmandu University School of Medical SciencesUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 8 Nov 2025 (actual)
- Study completion
- 8 Nov 2025 (actual)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Course Antibiotics | Active comparator | Drug: Standard Course AntibioticsNine postoperative doses of cefuroxime 750 mg; each dose every eight hours for three days |
| Short Course Antibiotics | Experimental | Drug: Short Course Antibiotics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short Course AntibioticsThree postoperative doses of cefuroxime 750 mg; each dose eight hours apart | Drug | Short Course Antibiotics |
| Standard Course AntibioticsNine postoperative doses of cefuroxime 750 mg; each dose eight hours apart | Drug | Standard Course Antibiotics |
Primary outcome
Incidence of Wound Infection based on ASEPSIS score
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 40416276Rodrigues 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.
- Background: PubMed 30166239Saleeb 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.
- Background: PubMed 34723233GBD 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short Course Antibiotics and Standard Course Antibiotics in people with Fracture Femur and Fracture Tibia, run by Kathmandu University School of Medical Sciences at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Wound Infection based on ASEPSIS score (time frame: From enrollment to the end of postoperative follow up at six week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07554079, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.