Health TrialsbyHealthPanel

Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients

ConditionsFracture Lower LegDiabetesFracture Fixation, Internal
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorTexas Tech University Health Sciences Center, El Paso

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Low extremity fracture requiring surgical treatment

Uncontrolled diabetes (Hemoglobin A1c > 7.0 or random glucose > 200 mg/dL)

Age 18 years or older

Able to provide informed consent

Disqualifiers

Known allergy to prescribed antibiotic and pre-determined alternatives

Open fractures

Current infection requiring antibiotic treatment

Immunocompromised status (chemotherapy, immunosuppressant medications)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cefadroxil 500 mg Capsules

    Drug

    Cefadroxil 500 mg, twice a day for 7 days

  • Clindamycin

    Drug

    Clindamycin 300 mg, three times a day for 7 days

  • Bactrim DS

    Drug

    Bactrim DS, twice a day for 7 days

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: No extended oral antibiotic prophylaxisNo intervention 0 interventions
Group B: Extended oral antibiotic prophylaxisExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Surgical site infection

Incidence of 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).

Time frame
90 days

Secondary outcomes

1

Antibiotic-related adverse effects

Incidence of antibiotic-related adverse effects

Time frame
90 days
2

Compliance with antibiotic regimen

Number of patients completing prescribed antibiotic regimen or not

Time frame
1 week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Texas Tech University Health Sciences Center, El Paso

Lead sponsor

University of Southern California

Collaborator

Source ClinicalTrials.gov
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