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

Not Applicable

Not yet recruiting

• Conditions: Burn Infection
• Interventions: Drug: using antibiotic; Drug: not using antibiotic

• Registration Number: NCT06221761
• Lead Sponsor: Ruijin Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-26
• Study First Submitted QC: 2024-01-14
• Last Update Submitted: 2024-01-14
• Study First Posted: 2024-01-24
• Last Update Posted: 2024-01-24
• Study Start: 2024-03-01
• Primary Completion: 2025-03-01
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
antibiotic group	using antibiotic	Using antibiotics within 72 hours after burns
Non antibiotic group	not using antibiotic	Not using antibiotics within 72 hours after burns

Primary Outcome Measures

Name	Time	Method
Negative rate of bacterial culture	hour 72	Number of cases with negative wound culture bacteria/total number of cases

Secondary Outcome Measures

Name	Time	Method
28 day mortality rate	28 day after burn	28 day mortality rate