The Evaluation of Postoperative Antibiotics in Non-Infected Mandible Fractures
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Evidence of infection as measured by presence of persistent swelling,
研究概览
简要总结
The purpose of the study is to evaluate if postoperative antibiotic use in patients with mandible trauma reduce the risk of postoperative infections and does the benefit differ based on severity, soft tissue loss, other concomitant injuries, and medical problems
详细描述
The purpose of this study is to evaluate the use of antibiotics postoperatively in non-infected mandible fractures compared to the lack of postoperative antibiotics in the same population.
The first outcome measure is infection. Evidence of infection includes persistent swelling, fever, recurrent swelling, erythema, and purulent discharge.
The second outcome measure is no infection. Absence of persistent swelling, fever, recurrent swelling, erythema, and purulent discharge.
Outcome measures will be assessed on follow-up visits: post op week 1, post op week 3, and post op week 6-8. Latest follow-up is up to 8 weeks. If the subject presents with any of the above mentioned symptoms during the 8 week post-op period, the subject will be considered positive for infection.
Prospective randomized trial: Control group will not receive any postoperative antibiotics other than what is accepted as preoperative prophylactic antibiotics as per current standards of care. Trial groups will receive a single post-operative dose administration of Unasyn 3g or Clindamycin 600mg (for penicillin allergies), then the patients in the trial group will be switched to oral Augmentin 875mg twice a day for 7 days (Amoxicillin and Clavulanic acid which is clinically interchangeable with Unasyn), or oral Clindamycin 150mg to 300mg four times a day for 7 days (for penicillin allergies). If the patient is discharged home prior to completing 7 days of oral antibiotic therapy, patient will receive prescription to finish the remaining doses of antibiotics for a total period of 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •All mandible fracture patients planned for Open Reduction and Internal Fixation (ORIF)
排除标准
- •Age - < 18 years
- •Pregnancy
- •Fracture Site - closed / non-dentate eg. Condylar neck, edentulous
- •Soft Tissue Injury - > Grade 4 (GSW)
- •Allergic to all study drugs
- •Medical Problems
- •Diabetes - Hb A1C > 10
- •Immunologic compromise
- •On Chemotherapy
- •Interval - Injury to Surgery - > 10days
- •Already receiving antibiotics for
- •Another wound eg. Open fracture prophylaxis
- •Documented / suspected infection
- •Inability to provide informed consent.
研究组 & 干预措施
Treatment
Trial groups will receive a single post-operative dose administration of Unasyn 3g or Clindamycin 600mg (for penicillin allergies), then the patients in the trial group will be switched to oral Augmentin 875mg twice a day for 7 days (Amoxicillin and Clavulanic acid which is clinically interchangeable with Unasyn), or oral Clindamycin 150mg to 300mg four times a day for 7 days (for penicillin allergies). If the patient is discharged home prior to completing 7 days of oral antibiotic therapy, patient will receive prescription to finish the remaining doses of antibiotics for a total period of 7 days.
干预措施: Antibiotic treatment (Unasyn or Cleocin) (Drug)
Treatment
Trial groups will receive a single post-operative dose administration of Unasyn 3g or Clindamycin 600mg (for penicillin allergies), then the patients in the trial group will be switched to oral Augmentin 875mg twice a day for 7 days (Amoxicillin and Clavulanic acid which is clinically interchangeable with Unasyn), or oral Clindamycin 150mg to 300mg four times a day for 7 days (for penicillin allergies). If the patient is discharged home prior to completing 7 days of oral antibiotic therapy, patient will receive prescription to finish the remaining doses of antibiotics for a total period of 7 days.
干预措施: Antibiotic treatment (Augmentin or Cleocin) (Drug)
Control
Control group will not receive any postoperative antibiotics other than what is accepted as preoperative prophylactic antibiotics as per current standards of care.
干预措施: Control Group (Other)
结局指标
主要结局
Evidence of infection as measured by presence of persistent swelling,
时间窗: post treatment week 6-8
Evidence of infection as measured by presence of fever
时间窗: post treatment week 6-8
Evidence of infection as measured by presence of purulent discharge
时间窗: post treatment week 6-8
Evidence of infection as measured by presence of erythema
时间窗: post treatment week 6-8
Evidence of infection as measured by presence of recurrent swelling
时间窗: post treatment week 6-8
次要结局
- No evidence of infection as measured by absence of fever(post treatment week 6-8)
- No evidence of infection as measured by absence of erythema(post treatment week 6-8)
- No evidence of infection as measured by absence of purulent discharge(post treatment week 6-8)
- No evidence of infection as measured by absence of persistent swelling(post treatment week 6-8)
- No evidence of infection as measured by absence of recurrent swelling(post treatment week 6-8)
研究者
Nagi Demian
Professor
The University of Texas Health Science Center, Houston