Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients
2 other identifiers
interventional
40
1 country
3
Brief Summary
The goal of this clinical trial is to learn if taking an antibiotic pill for 7 days after surgery reduces the risk of wound infection in adults with poorly controlled diabetes who have surgery to fix a broken bone in the leg, ankle, or foot. It will also learn about the safety of the extended antibiotic course. The main questions it aims to answer are: Does a 7-day antibiotic course after surgery lower the rate of wound infection within 90 days? What medical problems do participants have when taking the extended antibiotic course? Researchers will compare a 7-day course of an oral antibiotic (cefadroxil) to standard care (no additional antibiotics after surgery) to see if the extended course reduces infections. Participants will: Take an antibiotic pill or receive standard care for 7 days after surgery Receive a phone call from the study team about 1 week after surgery Visit the clinic at 3 weeks, 6 weeks, and 3 months after surgery for checkups
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2026
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2026
CompletedFirst Submitted
Initial submission to the registry
April 24, 2026
CompletedFirst Posted
Study publicly available on registry
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
May 1, 2026
April 1, 2026
1.8 years
April 24, 2026
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Surgical site infection
Superficial infection (a wound with erythema, warmth, or drainage that is treated with oral antibiotics or wound care) and deep infection (per fracture-related infection definition).
90 days
Secondary Outcomes (2)
Antibiotic-related adverse effects
90 days
Compliance with antibiotic regimen
1 week
Study Arms (2)
Control
NO INTERVENTIONStandard of care (no extended oral antibiotic prophylaxis)
Intervention
EXPERIMENTALExtended oral antibiotic therapy
Interventions
Cefadroxil 500 mg, twice a day for 7 days
Eligibility Criteria
You may qualify if:
- Low extremity fracture requiring surgical treatment
- Uncontrolled diabetes (HbA1c \> 7.0 or random glucose \> 200 mg/dL)
- Age 18 years or older
- Able to provide informed consent
- English or Spanish speaker
You may not qualify if:
- Known allergy to prescribed antibiotic and pre-determined alternatives
- Open fractures
- Current infection requiring antibiotic treatment
- Immunocompromised status (chemotherapy, immunosuppressant medications)
- End-stage renal disease that medication dosing cannot be adjusted for
- Pregnant or breast-feeding
- Unable to comply with follow-up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
USC
Los Angeles, California, 90033, United States
University Medical Center of El Paso
El Paso, Texas, 79905, United States
Texas Tech Health El Paso
El Paso, Texas, 79912, United States
Related Publications (4)
Lipson S, Pagani NR, Moverman MA, Puzzitiello RN, Menendez ME, Smith EL. The Cost-Effectiveness of Extended Oral Antibiotic Prophylaxis for Infection Prevention After Total Joint Arthroplasty in High-Risk Patients. J Arthroplasty. 2022 Oct;37(10):1961-1966. doi: 10.1016/j.arth.2022.04.025. Epub 2022 Apr 25.
PMID: 35472436BACKGROUNDDasari SP, Kanumuri SD, Yang J, Manner PA, Fernando ND, Hernandez NM. Extended Prophylactic Antibiotics for Primary and Aseptic Revision Total Joint Arthroplasty: A Meta-Analysis. J Arthroplasty. 2024 Sep;39(9S2):S476-S487. doi: 10.1016/j.arth.2024.01.014. Epub 2024 Jan 17.
PMID: 38237874BACKGROUNDInabathula A, Dilley JE, Ziemba-Davis M, Warth LC, Azzam KA, Ireland PH, Meneghini RM. Extended Oral Antibiotic Prophylaxis in High-Risk Patients Substantially Reduces Primary Total Hip and Knee Arthroplasty 90-Day Infection Rate. J Bone Joint Surg Am. 2018 Dec 19;100(24):2103-2109. doi: 10.2106/JBJS.17.01485.
PMID: 30562290BACKGROUNDKheir MM, Dilley JE, Ziemba-Davis M, Meneghini RM. The AAHKS Clinical Research Award: Extended Oral Antibiotics Prevent Periprosthetic Joint Infection in High-Risk Cases: 3855 Patients With 1-Year Follow-Up. J Arthroplasty. 2021 Jul;36(7S):S18-S25. doi: 10.1016/j.arth.2021.01.051. Epub 2021 Jan 23.
PMID: 33589279BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 24, 2026
First Posted
May 1, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share