ClinicalTrials.gov
ClinicalTrials.gov Menu

Biofilm Infection in Adults and Children Burn Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03248154
Recruitment Status : Recruiting
First Posted : August 14, 2017
Last Update Posted : August 14, 2017
Sponsor:
Collaborator:
Nationwide Children's Hospital
Information provided by (Responsible Party):
Gayle Gordillo, Ohio State University

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.

Condition or disease Intervention/treatment Phase
Thermal Burn Wound Device: Procellera Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Burn Biofilm Infection in Adults and Children
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns

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?



Primary Outcome Measures :
  1. Detection of biofilm infection in burns [ Time Frame: 4 weeks ]
    Tissue biopsies will be tested for presence of bacteria using SEM and culture.


Secondary Outcome Measures :
  1. Assessing graft loss as a result of biofilm infection [ Time Frame: 4 weeks post grafting surgery ]
    TEWL measurement (g/square meter/h) as an indicator of lost barrier function

  2. Burn depth measurement [ Time Frame: 4 weeks ]
    Harmonic Ultrasound & Doppler (HUSD) imaging will provide tissue depth expressed in relevant unit


Other Outcome Measures:
  1. Examining children vs adults for biofilm resistance [ Time Frame: 2 weeks post grafting surgery ]
    TNF-a measurement through cytokine assay (pg/ml)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248154


Contacts
Contact: Melissa Driscoll, RN 614-293-0390 melissa.driscoll@osumc.edu
Contact: Gayle M Gordillo, MD 614-293-8566 gayle.gordillo@osumc.edu

Locations
United States, Ohio
University Hospital East Recruiting
Columbus, Ohio, United States, 43203
Contact: Melissa Driscoll, RN    614-293-0390    melissa.driscoll@osumc.edu   
Contact: Amy H LPN, LPN    614-366-2783    Amy.Hoover@osumc.edu   
Principal Investigator: Gayle M Gordillo, MD         
Davis Heart and Lung Research Institute Recruiting
Columbus, Ohio, United States, 43210
Contact: Sashwati Roy, Ph.D    614-247-7657    sashwati.roy@osumc.edu   
Contact: Melissa Driscoll, RN    614-293-0390    melissa.driscoll@osumc.edu   
Principal Investigator: Gayle M Gordillo, MD         
The Ohio State University/Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Melissa Driscoll, RN    614-293-0390    melissa.driscoll@osumc.edu   
Principal Investigator: Gayle M Gordillo, MD         
Martha Morehouse Medical Plaza 2050 Kenny Road Recruiting
Columbus, Ohio, United States, 43221
Contact: Melissa Driscoll, RN    614-293-0390    melissa.driscoll@osumc.edu   
Principal Investigator: Gayle M Gordillo, MD         
Sponsors and Collaborators
Gayle Gordillo
Nationwide Children's Hospital
Investigators
Principal Investigator: Gayle M Gordillo, MD gayle.gordillo@osumc.edu

Responsible Party: Gayle Gordillo, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT03248154     History of Changes
Other Study ID Numbers: 16-00244
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: August 14, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Gayle Gordillo, Ohio State University:
Biofilm
Procellera

Additional relevant MeSH terms:
Burns
Wounds and Injuries