Randomized Controlled Trial of Antibiotics in the Management of Children With Community-Acquired Skin and Soft Tissue Abscess Undergoing Incision and Drainage
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Clinical Resolution of Skin Abscess at Routine Follow-up Visit 10-14 Days Post Operation.
研究概览
简要总结
The purpose of this study is to better understand why children develop methicillin-resistant Staphylococcus aureus (MRSA) skin infections that require surgical drainage and whether antibiotics are helpful after the infection is drained in the operating room.
详细描述
The emergence of community acquired methicillin-resistant Staphylococcus aureus (MRSA) as a pervasive cause of skin and soft tissue infections has increased the number of children requiring incision and drainage (I&D) procedures and heightened concerns about the optimal treatment strategy. Data on patients with methicillin-sensitive Staphylococcus aureus (MSSA) abscesses, as well as emerging data on children with minor MRSA skin and soft tissue abscesses suggest that I&D alone is sufficient therapy. However, given concerns about the pathogenicity of MRSA infections, many patients who require hospital admission and I&D in the operating room receive postoperative antibiotics. The primary objective of this randomized controlled trial is to compare the effect of 5 days versus 1 day of postoperative antibiotics on the rate of treatment failure following I&D of abscesses in children in the era of pervasive MRSA infection. Secondary outcomes to be measured include incidence of additional skin and soft tissue infections in other body sites and incidence of these infections in family members and household contacts. Prospective data will be collected from wound cultures, as well as from nasal, rectal and skin cultures sent at the time of initial I&D to assess for MRSA carrier status. Finally, survey data will be used to assess epidemiologic risk factors.
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
- 1 Month 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children between 1 month and 17 years of age who undergo Incision and Drainage of a skin and soft tissue abscess by a member of the Children's Memorial Hospital pediatric surgery faculty.
排除标准
- •Children who developed their infection while hospitalized or within 2 weeks of unrelated hospital discharge will be excluded.
- •Children with surgical site infections will be excluded.
- •Children with inherent or acquired immunodeficiency, including but not limited to transplant patients and patients on chemotherapy or systemic corticosteroids will be excluded.
- •Patients admitted to the Infectious Disease service may be excluded at the discretion of the ID attending.
- •Patients who are found to have no discreet fluid collections at the time of attempted incision and drainage will be excluded.
- •Patients allergic or intolerant to both bactrim and clindamycin will be excluded.
- •Patients with cellulitis greater than 5 cm beyond the lateral margin of the abscess (as determined by intraoperative measurements) will be excluded.
研究组 & 干预措施
5 days postoperative antibiotic
Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).
干预措施: Oral Clindamycin (Drug)
1 day postoperative antibiotic
Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).
干预措施: Oral Clindamycin (Drug)
结局指标
主要结局
Clinical Resolution of Skin Abscess at Routine Follow-up Visit 10-14 Days Post Operation.
时间窗: At office visit 10-14 days post operation
次要结局
- Additional Skin and Soft Tissue Infections in Patient(Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op)
- Additional Skin or Soft Tissue Infections in Household Contacts(Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op)
- Complication to Antibiotic Regime(Three timepoints: 10-14 days post operation, 3 months post op, and 9 months post op)
研究者
Katherine Barsness, MD
Attending Physician, Department of Surgery
Ann & Robert H Lurie Children's Hospital of Chicago