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WithdrawnNCT03248154Updated Jan 4, 2022

Biofilm Infection in Adults and Children Burn Injury

An interventional study of Procellera in Thermal Burn and Wound, sponsored by Gayle Gordillo. Withdrawn at 4 sites in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2022-01-04.

Sponsored by Gayle Gordillo · Not applicable, Interventional, and Treatment

Why this study was withdrawn
did not receive funding
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
2 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Thermal Burn
  • Wound

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Keywords

  • Biofilm
  • Procellera
03

In context

Wounds and Injuries

5,085 studies on the registry are indexed under Wounds and Injuries; 849 are open to participants now.

Browse Wounds and Injuries studies →

Lead sponsor

Gayle Gordillo is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

  • 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?

Interventions

  • DeviceProcellera

    burn dressing

06

What researchers measure

Primary outcomes

  1. Detection of biofilm infection in burns

    Tissue biopsies will be tested for presence of bacteria using SEM and culture.

    Time frame: 4 weeks

Secondary outcomes

  1. Assessing graft loss as a result of biofilm infection

    TEWL measurement (g/square meter/h) as an indicator of lost barrier function

    Time frame: 4 weeks post grafting surgery

  2. Burn depth measurement

    Harmonic Ultrasound \& Doppler (HUSD) imaging will provide tissue depth expressed in relevant unit

    Time frame: 4 weeks

Other outcomes

  1. Examining children vs adults for biofilm resistance

    TNF-a measurement through cytokine assay (pg/ml)

    Time frame: 2 weeks post grafting surgery

07

Study locations

4 sites
  • University Hospital East
    Columbus, Ohio 43203, United States
  • Davis Heart and Lung Research Institute
    Columbus, Ohio 43210, United States
  • The Ohio State University/Ohio State University Wexner Medical Center
    Columbus, Ohio 43210, United States
  • Martha Morehouse Medical Plaza 2050 Kenny Road
    Columbus, Ohio 43221, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03248154
Lead sponsor
Gayle Gordillo
Responsible party
Gayle Gordillo (Associate Professor, Ohio State University) — Sponsor-investigator
First posted
Aug 14, 2017
Start date
Jan 2017 (estimated)
Primary completion
Dec 2021 (estimated)
Completion
Dec 2022 (estimated)
Last update
Jan 4, 2022

Study contacts

Gayle M Gordillo, MD
principal investigator · Indiana University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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