Tetanus Prophylaxis
Conditions
Interventions
Experimental group:Receive standard debridement + secukinumab (according to the dosage instructions, typically 10mg, administered via deep intramuscular injection).
Control group:Receive standard debridement + human tetanus immunoglobulin (HTIG)
Sponsors
Army Medical Center of PLA
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years; 2.Patients presenting to the emergency department following trauma, with high-risk wounds defined by a Tetanus Immunity and Wound Classification Score of > 6; 3.Possession of a smartphone or landline telephone, with a willingness to comply with scheduled follow-ups (via telephone or WeChat); 4.Voluntary provision of signed written informed consent.
Exclusion criteria
Exclusion criteria: 1.Known history of severe hypersensitivity to biological products, human immunoglobulins, or monoclonal antibodies; 2.Patients with life-threatening wounds requiring immediate resuscitation, or those admitted to the ICU requiring deep sedation(rationale: deep sedation may mask or confound the clinical observation of early tetanus symptoms); 3.Documented history of complete tetanus immunization within the past 5 years (rationale: passive immunization is not indicated for this population; only an active vaccine booster is required); 4.Pregnant or lactating women; 5.Current participation in any other interventional clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of any adverse events (AEs) within 7 days after administration (non-inferiority indicator); | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient treatment satisfaction;Clinical protective effect;VAS pain scores immediately and 30 minutes after injection (superiority indicator);Treatment adherence in patients with high-risk wounds; | — |
Countries
China
Contacts
Public ContactLi Yang
Army Medical Center of PLA
Outcome results
None listed