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

January 14, 2024 updated by: Ruijin Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non antibiotic group
Not using antibiotics within 72 hours after burns
Drug: not using antibiotic
no antibiotic application
Active Comparator: antibiotic group
Using antibiotics within 72 hours after burns
Drug: using antibiotic
antibiotic application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative rate of bacterial culture
Time Frame: hour 72
Number of cases with negative wound culture bacteria/total number of cases
hour 72

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
28 day mortality rate
Time Frame: 28 day after burn
28 day mortality rate
28 day after burn

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

December 26, 2023

First Submitted That Met QC Criteria

January 14, 2024

First Posted (Actual)

January 24, 2024

Study Record Updates

Last Update Posted (Actual)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 14, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20231226

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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