Intraoperative wound irrigation to prevent surgical site infection afterlaparotomy

Technische Universität München Fakultät für Medizin0 个研究点目标入组 680 人开始时间: 2017年4月26日最近更新: 2022年1月17日

适应症

试验速览

暂无简介。

•Clean-contaminated, contaminated or dirty surgery according to Centre for Disease Control (CDC) classification;
•Abdominal surgery by midline or transverse laparotomy; elective and emergency procedures;
•Age = 18 years;
•American Society of Anesthesiologists (ASA) score = 3;
•Ability to understand the nature and extent of the trial and to give written informed consent;
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 300
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 240

•Pregnancy or breast feeding;
•Known hypersensitivity/allergy to PHX;
•Inability to understand/give informed consent;
•Critical medical condition of emergency patients, precluding informed consent or sufficient time to reflect on the decision to participate in the trial
•Inability to attend follow-up visits;
•Clean procedures according to the CDC classification or surgery without opening of the abdominal cavity;
•Laparoscopic surgery;
•Revision-surgery (previous abdominal surgery within the last 30 days);
•Planned re-laparotomy within 30 days;
•Severe immunosuppression;
•Concurrent abdominal wall infections;
•Pre-operative antibiotic therapy (within 5 days prior to surgery) except for emergencies due to septic peritonitis
•Participation in another clinical trial that interferes with the primary or secondary outcomes of this trial

发起方

Technische Universität München Fakultät für Medizin