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Clinical study on safety and efficacy of nitroimidazoles used prophylactically in oral and maxillofacial surgery

Clinical study on safety and efficacy of nitroimidazoles used prophylactically in oral and maxillofacial surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052364
Enrollment
Unknown
Registered
2021-10-24
Start date
2021-10-20
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

oral and maxillofacial surgery

Interventions

group A :Ornidazole drug
group B :Metronidazole Sodium Chloride Injection
group C :Tinidazole Glucose Injection

Sponsors

The Third Affiliated Hospital of Air Force Medical University, PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged above 18 years old and below 65 years old; 2. Resection of oral cavity, tongue, neck tumor, etc. (through the oropharyngeal mucosa); 3. No pre-hospital infectious diseases, and no other anti-anaerobic drugs within two weeks before surgery; 4. No hematopoietic, digestive system, autoimmune system, cardiovascular system and other diseases; 5. No symptoms of infection in the whole body; 6. No surgical contraindications; 7. The surgical incision is Class II or Class III; 8. No history of drug allergy; 9. The operation time should not exceed 6 hours; 10. Patients voluntarily participated in this study, signed the informed consent, and were able to cooperate with clinical follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with severe trauma and mental illness; 2. Women who are pregnant or breastfeeding; 3. Those who fail to use up the drug as required; 4. Intellectual disability, mental disorder; 5. Women who are planning to become pregnant, pregnant or breastfeeding and cannot strictly contracept during the test; 6. Participated in other clinical trials within the past 1 month; 7. The investigator believes that it is not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
The incidence of infection in surgical incisions;

Countries

China

Contacts

Public ContactFeng Bin

The Third Affiliated Hospital of PLA Air Force Military Medical University

binfeng@fmmu.edu.cn+86 18092390815

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026