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临床试验/NCT01194115
NCT01194115Unknown不适用

Use of 48 Hour Course of Antibiotics to Prevent Surgical Site Infection in Obese Patients Undergoing Cesarean Delivery

University of Cincinnati1 个研究点 分布在 1 个国家目标入组 475 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
475
试验地点
1
主要终点
Surgical site infection

研究概览

简要总结

The purpose of this study is to evaluate if preoperative antibiotics, followed by 48 hour course of broad spectrum antibiotics prevents wound infection complications in patients that are obese who undergo cesarean section. Standard antibiotic prophylaxis in all weight women undergoing cesarean section is cefazolin prior to skin incision. It is the hypothesis that a prolonged, 48 hour course of broad spectrum antibiotics that are suited to prevent growth of normal vaginal flora will decrease the rate of surgical site infection in obese patients that are at a greatly increased risk of postoperative infections complications.

详细描述

We propose the conduction of a prospective, randomized, double-blinded clinical trial to evaluate an alternative prophylactic regimen for the prevention of surgical site infection. This study is to be conducted by the Department of Obstetrics at University Hospital. The intervention being studied will be the continuation of cephalexin and metronidazole for 48 hours. The primary outcome measure will be the development of infectious morbidity, including wound infection and endometritis, in the postoperative period.

In order to most effectively and accurately analyze our primary and secondary research outcomes, the investigators will standardize our surgical operation techniques in all ways feasible. These recommendations will be in concordance with American College of Obstetrics and Gynecology recommendations, as those generally accepted in the medical literature. All patients will undergo surgery in the same small group of HEPA filtration and positive air pressure operating rooms. Appropriate limitations on number of surgeons and assistants scrubbed for surgery as well as general OR traffic will be enforced. Patients will undergo hair clipping of the incision site when appropriate. Chlorhexidine skin decontamination will be the standard surgical site preparation. An antimicrobial, adhesive drape will be used. Prior to skin incision, cefazolin will be administered.

All patients to be considered for recruitment to this study will be undergoing delivery at University Hospital. Patients with an elevated BMI > 30 kg/m2 who undergo cesarean section will be considered for randomization either prior to delivery or in the first 7 hours after delivery, to accommodate the need for the first dose of study medication or placebo 8 hours after surgery. Only patients who agree to inclusion after informed consent will be randomized per protocol.

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
13 Years 至 —(Child, Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • BMI > 30kg/m*2
  • Delivery via cesarean section
  • consent to participate
  • age 13 or older

排除标准

  • known immunodeficiency syndromes
  • non-English speaking
  • known allergy to cephalosporins or metronidazole

研究组 & 干预措施

Cephalexin and metronidazole

Experimental

500 mg cephalexin per oral every 8 hours for total of 6 doses; 500 mg metronidazole per oral every 8 hours for total of 6 doses

干预措施: cephalexin & metronidazole (Drug)

Placebo/standard of care

Placebo Comparator

Placebo pills per oral every 8 hours for total of 6 doses

干预措施: placebo (Drug)

结局指标

主要结局

Surgical site infection

时间窗: 6weeks post partum

次要结局

  • Febrile morbidity; Urinary tract infection; Endometritis(6 weeks post partum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rose Maxwell, Ph.D.

Director of Clinical Research

University of Cincinnati

研究点 (1)

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