Biofilm Infection in Adults and Children Burn Injury

Burn Biofilm Infection in Adults and Children

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.

Study Overview

• Status: Withdrawn
• Conditions: Wound; Thermal Burn
• Intervention / Treatment: Device: Procellera

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).

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Davis Heart and Lung Research Institute
    • Columbus, Ohio, United States, 43203
      • University Hospital East
    • Columbus, Ohio, United States, 43210
      • The Ohio State University/Ohio State University Wexner Medical Center
    • Columbus, Ohio, United States, 43221
      • Martha Morehouse Medical Plaza 2050 Kenny Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Immunocompetent with 2-14% TBSA; Immunocompetent with 2-14% TBSA thermal burn subjects. Does biofilm infection result in conversion of partial-thickness burn wounds to full-thickness?
Experimental: Immunocompromised with >=20% TBSA; Immunocompromised patients with large thermal burn >=20% TBSA. Higher bacterial burden with biofilm infection will result in higher rates of graft loss. Does application of a wireless electroceutical dressing (Procellera) lower biofilm burden compared to burn subjects receiving standard of care therapy?	Device: Procellera; burn dressing
No Intervention: Peripheral blood - all subjects; All subjects enrolled in arms 1 and 2. Do children have a more robust innate immune response to prevent biofilm infection?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of biofilm infection in burns	Tissue biopsies will be tested for presence of bacteria using SEM and culture.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessing graft loss as a result of biofilm infection	TEWL measurement (g/square meter/h) as an indicator of lost barrier function	4 weeks post grafting surgery
Burn depth measurement	Harmonic Ultrasound & Doppler (HUSD) imaging will provide tissue depth expressed in relevant unit	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examining children vs adults for biofilm resistance	TNF-a measurement through cytokine assay (pg/ml)	2 weeks post grafting surgery

Collaborators and Investigators

• Sponsor: Gayle Gordillo
• Collaborators: Nationwide Children's Hospital
• Investigators: Principal Investigator: Gayle M Gordillo, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2017
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 8, 2017
• First Submitted That Met QC Criteria: August 9, 2017
• First Posted (Actual): August 14, 2017

Study Record Updates

• Last Update Posted (Actual): January 4, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Biofilm; Procellera
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: 16-00244

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No