Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery

Официальное название

Intra-wound Vancomycin Powder for Prevention of Surgical Site Infection Following Spinal Surgery - a Randomized Controlled Superiority Trial

Обзор

Cefazolin is given routinely pre and intraoperatively for patients undergoing spinal surgery to reduce the rate of infection. Intra-wound admission of Vancomycin powder has been suggested to reduce wound infection rates. Therefore, this study aims to compare the rate of wound-related complications between patients receiving standard treatment compared to patients receiving an addition of topical Vancomycin and to identify the optimal Vancomycin dosage. All groups will receive the recommended regimen of routine IV antibiotic prophylaxis.

Вмешательства

• Препарат Vancomycin
  Powdered vancomycin will be locally administered once during surgery. The vancomycin will be placed in the surgical bed at several layers: around the hardware and before muscle apposition and above the fascia. This is done before the closure of the muscular fascia and skin by the neurosurgeon. The vancomycin will not be mixed in the bone graft.

Первичные конечные точки

• Incidence of deep spinal infections [Срок оценки: One year]

Вторичные конечные точки (9)

• Incidence of superficial spinal infections [Срок оценки: One year]
• Individual components of the composite primary outcomes [Срок оценки: One year]
• Rate of Surgical site infection revisions [Срок оценки: 30 days]
• Number of adverse events [Срок оценки: Up to one week post-surgery]
• Length of hospitalization [Срок оценки: From operation date to discharge (up to 4 weeks) or date of death]
• Rate of mortality [Срок оценки: One year]
• Rate of post-operative seroma [Срок оценки: 30 days]
• Concentration of creatinine (mg/dl), glucose (mg/dl) and albumin (g/dl) [Срок оценки: Pre-operation, Post-operation Day 3, Post-operation Day 7, Post-operation Day 30]
• Serum vancomycin levels [Срок оценки: 6 and 12 hours post op and then one test a day until vancomycin levels reach zero]

Критерии участия

Критерии включения

• Patients undergoing posterior spinal fusion operation at the neurosurgery department at the Rabin Medical Center
• Ability to understand and sign written informed consent by the patient or legal guardian

Критерии исключения

• Preoperative ongoing infectious disease present as judged by the primary surgeon (based on lab results and clinical assessment)
• Receiving ongoing treatment of antibiotics for other infections
• Sensitivity or allergy to vancomycin or cefazolin
• Previous spine surgery at the index level within the last 90 days
• Postoperative radiotherapy of the surgical site required (e.g. for tumor)
• Renal insufficiency with stage 4 chronic kidney disease (CKD) with a glomerular filtration rate (GFR) of 15-30 ml/min or worse
• Undergoing spinal decompression only
• Trauma patients
• Pregnancy

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

Тройное слепое

Основная цель

Профилактика

Центры проведения

Израиль · 1 центр

• Rabin Medical Center — Petah Tikva

Идентификаторы

NCT: NCT05959603 · RMC 0103-20

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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