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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06221761
Enrollment
240
Registered
2024-01-24
Start date
2024-03-01
Completion date
2025-06-30
Last updated
2024-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn Infection

Keywords

burn, infection, antibiotic

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.

Interventions

DRUGnot using antibiotic

no antibiotic application

DRUGusing antibiotic

antibiotic application

Sponsors

Ruijin Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participants do not know which group they will be assigned to.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Negative rate of bacterial culturehour 72Number of cases with negative wound culture bacteria/total number of cases

Secondary

MeasureTime frameDescription
28 day mortality rate28 day after burn28 day mortality rate

Contacts

Primary ContactDou Yi
douyi815@hotmail.com862164370045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026