Retrospective, Multi-centric Study Comparing the Incidence of Surgical Site Infections in Patients Receiving Open Appendectomy With Double-ring Wound-edge Protectors Versus Laparoscopic Appendectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 671
- 试验地点
- 1
- 主要终点
- Superficial surgical site infection (sSSI)
研究概览
简要总结
This study aims to evaluate the utility of double-ring wound-edge protectors to prevent the development of superficial surgical site infections after open appendectomy.
详细描述
This is a multi-centric retrospective study comparing patients of similar characteristics with diagnosis of acute appendicitis that have been treated either by open appendectomy using a double-ring wound-edge protector or by laparoscopic appendectomy between January 2011 and December 2016 at Hospital Recoletas Campo Grande de Valladolid and Hospital Comarcal de Medina del Campo.
The main objective of the study is to compare the incidence of superficial surgical site infection in both groups.
All patients included in the study must meet inclusion criteria and all data will be collected anonymously in order to comply with local law on personal data protection (Organic Law 15/1999 from 13 December about personal data protection).
The authors of the study expect results of the study to be comparable with those in current literature regarding surgical site infections, hospital stay and procedure safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 15 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of at least 15 years old.
- •Clinical diagnosis of acute appendicitis.
- •Treated by: Open appendectomy + double-ring wound-edge protector or Laparoscopic appendectomy.
- •Note: with the aim of avoiding selection bias, all patients presenting risk factors for surgical site infections (eg obesity, diabetes, malnourishment, immunosupression, etc.) will be included in the present study.
排除标准
- •Patients who did not receive prophylactic antibiotic.
- •Source of abdominal pathology other than the caecal appendix.
- •Follow-up period less than 30 days.
结局指标
主要结局
Superficial surgical site infection (sSSI)
时间窗: 30 days after surgery
To compare the incidence of sSSI in both groups (OA+2RWEP versus LA) during postoperative period to determine wether 2RWEP are useful in reducing sSSI after open appendectomy.
次要结局
- Organ-space surgical site infection (oeSSI)(30 days)
- Hospital stay(30 days)
研究者
Johnn Henry Herrera Kok
Dr. Johnn Henry Herrera Kok
Hospital Medina del Campo