Status:

WITHDRAWN

Biofilm Infection in Adults and Children Burn Injury

Lead Sponsor:

Gayle Gordillo

Collaborating Sponsors:

Nationwide Children's Hospital

Conditions:

Thermal Burn

Wound

Eligibility:

All Genders

2+ years

Phase:

NA

Brief Summary

The objective of the study is to analyze the different implications (such as graft loss and conversion of indeterminate depth burns) of biofilm infections in burn patients. Additionally, it also aims ...

Detailed Description

Subjects will be recruited from three different age groups: 2-18 years old, 18-49 years old, and ≥ 50 years old. 150 patients will be enrolled in each age group for arms 1 and 2. Arm 3 consists of all...

Eligibility Criteria

Inclusion

  • Inclusion Criteria (Aim 3 is included in all criteria):
  • Aim 1 and 2:
  • Ages 2 yrs. and older
  • Aim 1:
  • Thermal burns with 2-14% total body surface area (TBSA) injury
  • Patients present within 3 days from the time of thermal burn injury
  • Diagnosed by burn surgeon as having deep partial thickness or indeterminate depth burn (defined as uncertainty between deep second degree or third degree burns)
  • Aim 2:
  • Thermal burns with ≥20% TBSA
  • Exclusion Criteria (Aim 3 is included in all criteria):
  • Aim 1 and 2:
  • Patients with chemical or electrical burns
  • Pregnant women
  • Patient/legal guardian/or next of kin unable to consent
  • Aim 1:
  • Immunosuppressed
  • Taking immune modifying medications
  • Patients requiring \>72 hrs. hospital stay
  • Harmonic Ultrasound \& Doppler Imaging (HUSD) will be used to exclude burn wounds with thrombosed vessels at initial presentation

Exclusion

    Key Trial Info

    Start Date :

    January 1 2017

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    December 1 2022

    Estimated Enrollment :

    Patients enrolled

    Trial Details

    Trial ID

    NCT03248154

    Start Date

    January 1 2017

    End Date

    December 1 2022

    Last Update

    January 4 2022

    Active Locations (4)

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    Page 1 of 1 (4 locations)

    1

    University Hospital East

    Columbus, Ohio, United States, 43203

    2

    Davis Heart and Lung Research Institute

    Columbus, Ohio, United States, 43210

    3

    The Ohio State University/Ohio State University Wexner Medical Center

    Columbus, Ohio, United States, 43210

    4

    Martha Morehouse Medical Plaza 2050 Kenny Road

    Columbus, Ohio, United States, 43221