Extended Oral Antibiotic Prophylaxis in Diabetic Fracture Patients

Официальное название

Extended Oral Antibiotic Prophylaxis in Diabetic Patients With Lower Extremity Fracture: A Multicenter Pilot Randomized Controlled Trial

Обзор

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

Подробное описание

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.

Вмешательства

• Препарат Cefadroxil 500 mg Capsules
  Cefadroxil 500 mg, twice a day for 7 days
• Препарат Clindamycin
  Clindamycin 300 mg, three times a day for 7 days
• Препарат Bactrim DS
  Bactrim DS, twice a day for 7 days

Первичные конечные точки

• Surgical site infection [Срок оценки: 90 days]

Вторичные конечные точки (2)

• Antibiotic-related adverse effects [Срок оценки: 90 days]
• Compliance with antibiotic regimen [Срок оценки: 1 week]

Критерии участия

Критерии включения

• 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
• English or Spanish speaker

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 3 центра

• University of Southern California — Los Angeles
• University Medical Center of El Paso — El Paso
• Texas Tech Health El Paso — El Paso

Публикации

• 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 35472436
• Dasari 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(9 Suppl 2):S476-S487. doi: 10.1016/j.arth.2024.01.014. Epub 2024 Jan 17. PMID 38237874
• Inabathula 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 30562290
• Kheir 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 33589279

Идентификаторы

NCT: NCT07561541 · E26052 · 4983

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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