A Study on the Prophylactic Use of Antibiotics Within 72 Hours After Acute Burn Injury in Patients

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Burn Infection

Treatments: Drug: not using antibiotic; Drug: using antibiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT06221761

20231226

Details and patient eligibility

About

The goal of this clinical trial is to compare in acute burn patients.

The main question it aims to answer are:

• what is the impact of early prophylactic use of antibiotics on prognosis Participants will be randomly divided into an antibiotic group and a non antibiotic group.

Researchers will compare the two groups to see the 72 hour wound bacterial culture negative rate.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed and dated informed consent form
• Promise to comply with research procedures and cooperate with the implementation of full process research
• Age 18 and above
• Emergency hospitalization of patients in the burn department, within 24 hours after injury
• No immunodeficiency disease, no history of using immunosuppressive drugs, no antibiotics being used or infectious diseases at the time of admission
• If a woman is in the reproductive period, she should not be pregnant

Exclusion criteria

• Unable to obtain informed consent from subjects, family members, or authorized agents
• At the time of admission, antibiotics were being administered
• During pregnancy
• Presence of infectious diseases before admission
• Existence of immunodeficiency diseases or use of immunosuppressive drugs
• The subjects are currently undergoing other clinical studies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

Non antibiotic group

Experimental group

Description:

Not using antibiotics within 72 hours after burns

Treatment:

Drug: not using antibiotic

antibiotic group

Active Comparator group

Description:

Using antibiotics within 72 hours after burns

Treatment:

Drug: using antibiotic