Surgical site infection following gastrointestinal surgery
Conditions
Interventions
Retrospective cohort (control group):No prophylactic use of anti-anaerobic agents
Prospective cohort (treatment arm):Prophylactic levornidazole disodium phosphate
Prospective Cohort (Control Group):No prophylactic use of anti-anaerobic agents
Retrospective cohort (treated group):Prophylactic nitroimidazole anti-anaerobic drugs
Sponsors
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Patients undergoing elective gastrointestinal surgery (involving gastrointestinal surgery such as stomach, duodenum, jejunum, ileum, colon, rectum); 18-75 years of age; prophylactic use of anti-anaerobic agents only (prospective cohort only); 2.Subjects volunteered and signed the informed consent form, and the process of signing the informed consent form complied with GCP requirements;
Exclusion criteria
Exclusion criteria: 1.Known or suspected hypersensitivity to nitroimidazoles; 2.Patients who have participated in other studies and received other investigational products within 3 months prior to screening; 3.Patients who are taking other drugs or have other diseases that may interfere with the evaluation of drug safety or efficacy; or patients who are at risk of serious drug interactions due to concomitant drugs (concomitant drugs such as warfarin and furosemide sodium, nafcillin sodium, omeprazole, vabizole, yanhuning for injection, azlocillin sodium, etc. that are incompatible with levornidazole); 4.Patients with cardiovascular, nervous system, endocrine system, hematopoietic system and other vital organs and systems serious primary diseases (such as heart failure, leukemia, uncontrolled diabetes, etc.); 5.Presence or suspicion of a psychiatric disorder with a predisposition to seizures; 6.Pregnant or lactating women, or women of childbearing potential with a positive pretest pregnancy test result; 7.Patients complicated with multiple organ failure; 8.Patients with severe liver and kidney dysfunction; 9.Life expectancy of less than 6-8 weeks; 10.Patients with autoimmune diseases, immunocompromised patients; 11.other patients who are not suitable for this clinical study according to the investigator 's opinion;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of surgical site infections, including surgical incision, deep organ, and lacunar infections, during hospitalization and 30 days after surgery.; | — |
Countries
China
Contacts
Public ContactQiang Li
Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Outcome results
None listed