A Phase 4 interventional study of Cefazolin and Cephalexin in Fractures, Open and Infections, sponsored by St. Louis University. Enrolling by invitation at 1 site in United States. Open to participants aged 0 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-10-20.
Sponsored by St. Louis University · Phase 4, Interventional, and Prevention
This research will involve a prospective study on infection rates after grade 1 or 2 open fractures in the skeletally immature pediatric population. There will be 3 arms: one dose intravenous cefazolin, 24 hours intravenous cefazolin, and 24 hours intravenous cefazolin plus 5 days of oral cephalexin.
Pediatric patients presenting with open fractures will be screened for eligibility at the time of presentation. Informed consent form discussion will take place within 8 hours of the patient's presentation, or before their second dose of antibiotics would be due (if randomized to group 2 or 3).
Upon arrival to the ED with an open fracture (grade I or II), the patient is assessed and care is initiated based on patient presentation. Patients are given an IV for medication administration and receive the first dose of antibiotics (cefazolin) as soon as possible. This is standard of care.
Treatment of the fracture includes irrigation with saline (at least 1 liter depending on wound size). The fracture then needs to be stabilized and wound closed. Patients are taken to the trauma room typically within 8 hours of presentation for sedation and closed reduction of the fracture. These practices are standard of care.
If the patient and guardian consent to the study, the patient will be randomized to one of three study arms:
A) one dose of IV cefazolin B) 24 hours IV cefazolin (3 doses Q8hrs) C) 24 hours IV cefazolin (3 doses Q8hrs) plus 5 days oral cephalexin.
Patients in group A will have no further antibiotic administration, assuming they received their first (and only) dose as soon as possible upon arrival. Patients in groups B and C will need to receive their second doses of IV cefazolin 8 hours after administration of the first dose. This is why we plan to consent the patients/guardians within 8 hours of presentation.
Aside from antibiotic administration, all other treatment will be standard of care. Patients will undergo closed reduction and any other medical management deemed necessary. Prior to discharge, participants will be educated on how to identify symptoms of infection. It is standard of care to discuss this during discharge education.
Frequency of follow up will be determined by standard of care treatment plan for age and fracture type. This is at the discretion of the physician. Typical follow up is at 1 week then 1 or 2 week intervals for up to 8-12 weeks. Study team members will check the patient's medical record for indication of infection or adverse events at each follow-up visit. If no follow up is reported after three months, study staff will conduct a phone interview to collect this data.
53 studies on the registry are indexed under Fractures, Open; 14 are open to participants now.
This study's planned enrollment of 800 is above the median of 90 across 40 interventional studies indexed under Fractures, Open.
Browse Fractures, Open studies →St. Louis University is the lead sponsor of 156 studies on the registry; 17 are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in group A will receive one dose of IV cefazolin and will have no further antibiotic administration.
Drug: Cefazolin
Patients in group B will receive a dose of IV cefazolin every 8 hours for 24 hours (a total of 3 doses).
Drug: Cefazolin
Patients in group C will receive a dose of IV cefazolin every 8 hours for 24 hours (a total of 3 doses). Additionally, they will be instructed to take 5 days of oral cephalexin.
Drug: Cefazolin · Drug: Cephalexin
Intravenous dose(s).
Five days oral.
Number of participants with an infection at the fracture site.
Participants will be monitored for infection at follow-up appointments and/or through follow-up phone contact.
Time frame: Up to 3 months following injury.
Drug adverse events
Any adverse side effects resulting from antibiotics administered.
Time frame: Up to 3 months following injury.
Started Sep 2023 (actual). Primary completion is estimated for Sep 2033, 120 months after the start.
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Studies of the drug tested here: Cephalexin