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

Burn Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06221761
• Other study ID #: 20231226
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: December 2023
• Source: Ruijin Hospital
• Contact: Dou Yi
• Phone: 862164370045
• Email: douyi815[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: June 30, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burn Infection
• Burns

Intervention

Drug:
• not using antibiotic
no antibiotic application
• using antibiotic
antibiotic application

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

References & Publications (2)

Avni T, Levcovich A, Ad-El DD, Leibovici L, Paul M. Prophylactic antibiotics for burns patients: systematic review and meta-analysis. BMJ. 2010 Feb 15;340:c241. doi: 10.1136/bmj.c241. — View Citation

ISBI Practice Guidelines Committee; Steering Subcommittee; Advisory Subcommittee. ISBI Practice Guidelines for Burn Care. Burns. 2016 Aug;42(5):953-1021. doi: 10.1016/j.burns.2016.05.013. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative rate of bacterial culture	Number of cases with negative wound culture bacteria/total number of cases	hour 72
Secondary	28 day mortality rate	28 day mortality rate	28 day after burn