A Randomized, Controlled Trial of the Effectiveness of Perioperative Antibiotics for Reduction of Burn Wound Bacterial Concentration Following Grafting
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- burn wound bacterial concentration
研究概览
简要总结
The purpose of this study if to evaluate the effectiveness of prophylactic antibiotics given during surgery in reducing the concentration of bacteria in a burn wound after surgery.
详细描述
This is a single-blind, randomized, controlled study to assess the effectiveness and safety of prophylactic perioperative administration of antibiotics for the reduction of bacterial concentration in burn wounds. Subjects who meet enrollment criteria will be randomized in a 1:1 ratio to receive either perioperative prophylaxis with intravenous antibiotics or institutional standard of care, consisting of no antibiotic therapy. This with be a single center study.
Following randomization, patients will receive their assigned treatment (antibiotics or standard of care) after induction of anesthesia, no more than one hour prior to incision.
Patients weighing 120 kg or less will receive 2 grams of intravenous cefazolin, with those weighing > 120 kg receiving 3 grams intravenous cefazolin. Re-dosing will occur every 4 hours that the patient remains in the operating room.
For patients with a documented beta-lactam allergy, Clindamycin 900 mg will be given intravenously with re-dosing every 6 hours that the patient remains in the operating room. Patients with allergies to both agents will be excluded from the study.
Biological samples will be obtained at three primary time-points: intraoperatively, at the time of the initial postoperative dressing take-down (within six hours), and at the time of a single follow up visit (10-28 days postoperatively).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject age ≥ 18 years old at the time of consent
- •Burn wound sustained less than 48 hours prior to the time of presentation to MedStar Washington Hospital Center
- •Burn wounds solely due to a thermal mechanism
- •Total body surface area burned ≤ 10%
- •Anticipated to require a single grafting procedure
- •Able to provide informed consent to participate
排除标准
- •Positive pregnancy test in females of child bearing age
- •Antibiotic administration within 30 days prior to admission
- •Known / documented beta lactam allergy and clindamycin allergy
- •Presence of burn wound cellulitis or infection pre-operatively
- •Intraoperative discovery of infection
- •Incarceration
- •Presence of factors that may affect wound healing, per clinician judgment, such as chronic malnutrition and immunocompromised state
研究组 & 干预措施
Antibiotics
Patients randomized to the treatment arm of the study will have orders placed by a physician on the clinical team, with preparation and delivery of the antibiotics dose by the pharmacy following standard procedures. Antibiotic administration will occur after induction of anesthesia, with delivery by the Anesthesia staff no more than one hour prior to incision. Those with known allergy to beta-lactams will receive clindamycin instead of cefazolin.
干预措施: Cefazolin (Drug)
Antibiotics
Patients randomized to the treatment arm of the study will have orders placed by a physician on the clinical team, with preparation and delivery of the antibiotics dose by the pharmacy following standard procedures. Antibiotic administration will occur after induction of anesthesia, with delivery by the Anesthesia staff no more than one hour prior to incision. Those with known allergy to beta-lactams will receive clindamycin instead of cefazolin.
干预措施: Clindamycin (Drug)
结局指标
主要结局
burn wound bacterial concentration
时间窗: 1-3 days from surgery
The primary effectiveness endpoint is a statistically significant reduction in the burn wound bacterial concentration in wounds where patients received antibiotics. Samples (tissue swabs and punch biopsies) obtained intraoperatively following wound bed preparation will be compared to samples (tissue swabs and punch biopsies) obtained from the wound within six hours of initial postoperative dressing take-down.
次要结局
未报告次要终点