A Multicenter, Surgeon-Matched Case-Control Study of Severe Surgical Site Infections (SSIs) Following Contaminated Or Dirty-infected Abdominal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 180
- 主要终点
- Percentage of Participants Who Showed Clinical Improvement of SSI
研究概览
简要总结
This is an observational study to evaluate the relative importance of the known risk factors for severe surgical site infections (SSIs) on the development of the more severe SSI cases, and to describe the demographic, clinical features, etiology and the management and outcome of patients suffering from severe SSIs in Spain.
详细描述
Case and Control study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Age of or above 18 years.
- •Admitted to a General Surgery Ward for elective or emergency abdominal surgery.
- •Contaminated or dirty-infected surgical procedures.
- •Only for cases, they will have to present symptoms and signs of a surgical site infection (SSI) (within 0-30 days) after abdominal surgery.
- •Only for controls, patients must be free of SSI after 30 days from surgery, regardless of whether they are still in the hospital or being observed as an outpatient in the external clinic.
排除标准
- •Age under 18 years.
- •American Society of Anesthesiologist (ASA) score of 5 or above.
- •Surgical implant in place.
- •Clean or clean-contaminated surgical procedures.
结局指标
主要结局
Percentage of Participants Who Showed Clinical Improvement of SSI
时间窗: Day 0 (day of surgery) up to 30 days post surgery
Clinical improvement of SSI was defined as healed (signs and symptoms of initial infection resolved) or improved (initial signs and symptoms significantly diminished without the appearance of new signs).
Percentage of Participants With Post-surgical Drainage
时间窗: Day 0 (day of surgery) up to 30 days post surgery
Percentage of Participants With Pre-surgical Morbidities
时间窗: Baseline (Pre-surgical)
Morbidities (risk factors) included: neoplasm, tobacco use, body mass index (weight in kilograms divided by height in meters squared \[BMI kg/m2\]) greater than (\>) 30, diabetes mellitus (DM), immunosuppression/ corticosteroids, anemia (hemoglobin \[Hb\] less than (\>) 9 grams per deciliter \[gr/dL\]) or malnutrition (hypoalbuminemia).
Percentage of Participants Who Received Pre-surgical Antibiotic Prophylaxis
时间窗: Baseline (Pre-surgical)
Percentage of Participants Who Underwent Emergency Surgery or Scheduled Surgery
时间窗: Day 0 (day of surgery)
Percentage of Participants With Classification of Risk of Surgical Infection of Clean-contaminated, Contaminated or Dirty
时间窗: Day 0 (day of surgery)
Surgical infection risk class: Clean-contaminated: controlled entry in normally colonized body cavities/no unusual contamination/minimum fluid discharge/minimal sterile technique violation/re-surgery on clean surgical incision within 7 days/negative surgical exploration through intact skin. Contaminated: no acute inflammation/purulent discharge/significant fluid/material violation of sterile technique/penetrating trauma less than 4 hours old/graft in chronic skin wounds. Dirty: pus-abscess drainage/ preoperatively colonized body cavity perforated/penetrating trauma more than 4 hours old.
Type of Surgeon
时间窗: Day 0 (day of surgery)
Surgical speciality of physician who performed surgery.
Percentage of Participants With Infection
时间窗: Day 0 (day of surgery) up to 30 days post surgery
Microorganism infection by bacterial type.
次要结局
- Percentage of Participants Whose National Nosocomial Infection Surveillance System (NNISS) Scores of Preoperative Risk of Infection Were Greater Than >0(Baseline (pre-surgical))
- ASEPSIS Classification in Participants With Serious SSI(Up to 30 days post surgery)
- Classification of SSI Infection(Day 0 (day of surgery) up to 30 days post surgery)
- Percentage of Participants Who Had Microbiologic Resolution of SSI (Sensitivity of Microorganisms to Antibiotics)(Day 0 (day of surgery) up to 30 days post surgery)
- Number of Participants With Antimicrobial Resistance(Day 0 (day of surgery) up to 30 days post surgery)