Extended Oral Antibiotic Prophylaxis in Diabetic Patients With Lower Extremity Fracture: A Multicenter Pilot Randomized Controlled Trial
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Texas Tech University Health Sciences Center, El Paso
- Enrollment
- 40
- Locations
- 3
- Primary Endpoint
- Surgical site infection
Overview
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
Detailed Description
The purpose of this research study is to investigate whether a 7-day course of an oral, prophylactic antibiotic following surgical fixation of a lower extremity fracture effectively decreases the risk of surgical site infection in patients with poorly controlled diabetes. Patients with an uncontrolled hemoglobin A1c greater than 7.0 or a random blood glucose greater than 200 mg/dL undergoing operative fixation of a closed fracture of the distal femur, patella, tibial plateau, tibial shaft, pilon, ankle, talus, calcaneus, or other operative foot fracture are considered high-risk for surgical site infection and are the target population for this study.
Study participants will be randomized to either a 7-day course of an oral prophylactic antibiotic following surgery (cefadroxil 500 mg twice daily, or an alternative regimen based on allergy status or methicillin-resistant Staphylococcus aureus colonization) or standard care with no additional antibiotics beyond the standard perioperative intravenous antibiotic dosing. All other standard perioperative fracture care will remain the same for both groups. Outcomes assessed will include superficial and deep surgical site infection occurring within 90 days of surgery, antibiotic-related adverse effects, and patient compliance with the extended antibiotic regimen.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Intervention
Extended oral antibiotic therapy
Intervention: Bactrim DS (Drug)
Control
Standard of care (no extended oral antibiotic prophylaxis)
Intervention
Extended oral antibiotic therapy
Intervention: Cefadroxil 500 mg Capsules (Drug)
Intervention
Extended oral antibiotic therapy
Intervention: Clindamycin (Drug)
Outcomes
Primary Outcomes
Surgical site infection
Time Frame: 90 days
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).
Secondary Outcomes
- Antibiotic-related adverse effects(90 days)
- Compliance with antibiotic regimen(1 week)
Investigators
Taylor M. Yong
Assistant Professor
Texas Tech University Health Sciences Center, El Paso