Clinical trial NCT03248154: Biofilm Infection in Adults and Children Burn Injury
Official title: Burn Biofilm Infection in Adults and Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Thermal Burn
Wound
Keywords: Biofilm
Procellera
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Nationwide Children's Hospital
First posted: 2017-08-14
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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 2cm² burn size, to 10 from \>8cm² 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).

Eligibility criteria: 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

Primary outcomes:
measure: Detection of biofilm infection in burns
timeFrame: 4 weeks
Secondary outcomes:
measure: Assessing graft loss as a result of biofilm infection
timeFrame: 4 weeks post grafting surgery
measure: Burn depth measurement
timeFrame: 4 weeks
Other outcomes:
measure: Examining children vs adults for biofilm resistance
timeFrame: 2 weeks post grafting surgery
Locations:
city: Columbus
country: United States
facility: University Hospital East
state: Ohio
city: Columbus
country: United States
facility: Davis Heart and Lung Research Institute
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University/Ohio State University Wexner Medical Center
state: Ohio
city: Columbus
country: United States
facility: Martha Morehouse Medical Plaza 2050 Kenny Road
state: Ohio
Study officials:
affiliation: Indiana University
name: Gayle M Gordillo, MD
role: PRINCIPAL_INVESTIGATOR
References: