Biofilm Infection in Adults and Children Burn Injury

  • STATUS
    Recruiting
  • End date
    Dec 21, 2022
  • participants needed
    300
  • sponsor
    Gayle Gordillo
Updated on 21 January 2021
graft loss

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 at comparing children's resistance to biofilm infection at wound site than adults'. 300 subjects from 3 different age groups will be enrolled in 3 arms.

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 patients enrolled in the study and involves drawing whole blood for analyzing cytokine response. Subjects will have at day 0, 3, 7, 14, 21, 28 +/- 2 days (as applicable until graft surgery occurs).At each study visit the following will be collected: burn wound data [Lund-Brower Chart, TBSA burn size, date of onset, length, width, area, depth of burn injury (as applicable), Standard of Care (SoC) treatment for burn] will be recorded, SoC labs since the onset of the burn wounds will be recorded (CBC w/ diff and glucose as applicable), digital imaging of the burn injury(s), Laser Doppler Imaging (LDI) will also be perfomed. Biopsies will be collected depending on the size of injury (4 from 2cm burn size, to 10 from >8cm burn size). Blister fluid will be collected by draining the fluid with a needle and syringe.Subjects in arm 2 will receive their Standard of Care (SoC) dressing prescribed by their provider or will receive the study dressing, 4x4 Procellera that will be applied to a specific area of the burn injury.

2 weeks after the grafting surgery, subjects will return for study visits at day 14, 21, 28 post-grafting where the following activities will be completed - burn wound data and medication review, digital image of the burn injury(s), LDI imaging, HUSD imaging, trans-epidermal water loss (TEWL) measurement. Whole blood will be collected.

Each subjects' medical chart will be followed for 3 months post completion of the study to identify patient outcomes (i.e. wound closure data, infection status/type, treatment status, surgical outcomes/complications - graft loss, patient death as applicable).

Details
Condition Trauma, Thermal Burns, Thermal Burn, Wounds, wound, traumatic injury
Treatment Procellera
Clinical Study IdentifierNCT03248154
SponsorGayle Gordillo
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 2 yrs?
Gender: Male or Female
Do you have any of these conditions: Thermal Burn or Trauma?
Do you have any of these conditions: wound or Thermal Burns or traumatic injury or Thermal Burn or Wounds or Trauma?
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 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
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