Biofilm Infection in Adults and Children Burn Injury

NCT ID: NCT03248154

Last Updated: 2022-01-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2022-12-31

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).

Conditions

Thermal Burn; Wound

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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?

Group Type: NO_INTERVENTION

No interventions assigned to this group

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?

Group Type: EXPERIMENTAL

Procellera

Intervention Type: DEVICE

burn dressing

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?

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Procellera

burn dressing

Intervention Type: DEVICE

Eligibility Criteria

Inclusion 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 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

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nationwide Children's Hospital

OTHER

Sponsor Role: collaborator

Gayle Gordillo

OTHER

Sponsor Role: lead

Responsible Party

Gayle Gordillo

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gayle M Gordillo, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

University Hospital East

Columbus, Ohio, United States

Davis Heart and Lung Research Institute

Columbus, Ohio, United States

The Ohio State University/Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Martha Morehouse Medical Plaza 2050 Kenny Road

Columbus, Ohio, United States

Countries

United States

Other Identifiers

16-00244

Identifier Type: -

Identifier Source: org_study_id