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

NCT06221761 | Unknown

• 1 other identifier: 20231226
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Burn Infection

Keywords

burn; infection; antibiotic

Outcome Measures

Primary Outcomes (1)

• Negative rate of bacterial culture

  Number of cases with negative wound culture bacteria/total number of cases

  hour 72

Secondary Outcomes (1)

• 28 day mortality rate

  28 day after burn

Study Arms (2)

Non antibiotic group

EXPERIMENTAL

Not using antibiotics within 72 hours after burns

Drug: not using antibiotic

antibiotic group

ACTIVE COMPARATOR

Using antibiotics within 72 hours after burns

Drug: using antibiotic

Interventions

not using antibiotic DRUG

no antibiotic application

Non antibiotic group

using antibiotic DRUG

antibiotic application

antibiotic group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Related Publications (2)

• 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.

  PMID: 27542292 RESULT

• 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.

  PMID: 20156911 RESULT

MeSH Terms

Conditions

Burns; Infections

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Dou Yi

CONTACT

862164370045; douyi815@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants do not know which group they will be assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly divided into two groups, one using antibiotics and the other not using antibiotics

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 24, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: June 30, 2025
• Last Updated: January 24, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share