Topical Antibiotic Irrigation (Gentamicin) in Prophylaxis of Midfacial Fracture Surgical Wounds
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Number of Participants With Surgical Site Infection (SSI)
研究概览
简要总结
The purpose of this study is to evaluate the use of topical antibiotic irrigation (gentamycin) and its ability to reduce surgical site infections in midfacial fracture surgery compared to sterile normal saline (NS).
Previously, this study evaluated a different antibiotic, bacitracin, but in April of 2020 the study was modified to use gentamycin rather than bacitracin, after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted removed bacitracin from its formulary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •patients who are planned for open reduction internal fixation of midfacial fractures as part of standard of care
- •patients who are admitted to Memorial Hermann hospital at Texas Medical Center
- •able to sign their own consent
排除标准
- •infected surgical sites
- •allergies to bacitracin
研究组 & 干预措施
topical irrigation with the antibiotic plus intravenous (IV) prophylactic antibiotic
Fractures will be topically irrigated with the topical antibiotic gentamicin (80mg diluted in 1L 0.9% normal saline) prior to closure.
[previously, this arm involve topical irrigation with bacitracin topical antibiotic (50,000 units), but in April of 2020 the study was modified to use gentamycin rather than bacitracin, after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted removed bacitracin from its formulary.]
干预措施: topical irrigation with gentamicin (80mg diluted in 1L 0.9% normal saline) (Drug)
topical irrigation with the antibiotic plus intravenous (IV) prophylactic antibiotic
Fractures will be topically irrigated with the topical antibiotic gentamicin (80mg diluted in 1L 0.9% normal saline) prior to closure.
[previously, this arm involve topical irrigation with bacitracin topical antibiotic (50,000 units), but in April of 2020 the study was modified to use gentamycin rather than bacitracin, after the FDA warning of the toxic side effects of bacitracin and because the hospital where the study was conducted removed bacitracin from its formulary.]
干预措施: intravenous (IV) prophylactic antibiotic (Drug)
topical irrigation with sterile normal saline (NS) plus intravenous (IV) prophylactic antibiotic
Fractures will be irrigated with sterile normal saline prior to closure. All groups with receive standard parenteral (IV) prophylactic antibiotic.
干预措施: topical irrigation with sterile normal saline (NS) (Drug)
topical irrigation with sterile normal saline (NS) plus intravenous (IV) prophylactic antibiotic
Fractures will be irrigated with sterile normal saline prior to closure. All groups with receive standard parenteral (IV) prophylactic antibiotic.
干预措施: intravenous (IV) prophylactic antibiotic (Drug)
结局指标
主要结局
Number of Participants With Surgical Site Infection (SSI)
时间窗: 8 weeks
Surgical site infections include evidence of infection: persistent swelling, fever, recurrent swelling, erythema, and purulent discharge.
次要结局
未报告次要终点
研究者
Nagi Demian
Professor
The University of Texas Health Science Center, Houston