Thermal BurnNCT03248154
Biofilm Infection in Adults and Children Burn Injury
A study testing Procellera in people with Thermal Burn and Wound, run by Gayle Gordillo at 4 sites in United States.
Trial 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'. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Thermal Burn, Wound
- What is being tested?
- Procellera
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2017to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University Hospital East
Columbus, Ohio, 43203
Davis Heart and Lung Research Institute
Columbus, Ohio, 43210
The Ohio State University/Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Martha Morehouse Medical Plaza 2050 Kenny Road
Columbus, Ohio, 43221
About this study
Official title: 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.
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).
- Conditions
- Thermal Burn, Wound
- Being tested
- Procellera
- Keywords
- Biofilm, Procellera
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProcelleraDevice
burn dressing
| Study group | Role | What they receive |
|---|---|---|
| Immunocompetent with 2-14% TBSA | No intervention | Immunocompetent with 2-14% TBSA thermal burn subjects. Does biofilm infection result in conversion of partial-thickness burn wounds to full-thickness? |
| Immunocompromised with >=20% TBSA | Experimental | 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? Receives: Device: Procellera |
| Peripheral blood - all subjects | No intervention | All subjects enrolled in arms 1 and 2. Do children have a more robust innate immune response to prevent biofilm infection? |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of biofilm infection in burns
Tissue biopsies will be tested for presence of bacteria using SEM and culture.
Measured: 4 weeks
Secondary outcomes (2)
Assessing graft loss as a result of biofilm infection
TEWL measurement (g/square meter/h) as an indicator of lost barrier function
Measured: 4 weeks post grafting surgery
Burn depth measurement
Harmonic Ultrasound \& Doppler (HUSD) imaging will provide tissue depth expressed in relevant unit
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study startJan 2017 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: did not receive funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thermal BurnStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gayle Gordillo
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Responsible party
- Sponsor-investigator, Gayle Gordillo, Ohio State University
- Investigators
- Gayle M Gordillo, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248154
- Sponsor's protocol ID
- 16-00244
- Status last verified
- Dec 2021
- First submitted
- 8 Feb 2017
- Last updated
- 4 Jan 2022
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burn Biofilm Infection in Adults and Children
- ClinicalTrials.gov ID
- NCT03248154
- Acronym / sponsor ID
- 16-00244
- Conditions
- Thermal Burn, Wound
- Keywords
- Biofilm, Procellera
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: did not receive funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Gayle GordilloUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Study start
- Jan 2017 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 14 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Immunocompetent with 2-14% TBSA | No intervention | –Immunocompetent with 2-14% TBSA thermal burn subjects. Does biofilm infection result in conversion of partial-thickness burn wounds to full-thickness? |
| Immunocompromised with >=20% TBSA | Experimental | Device: ProcelleraImmunocompromised 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? |
| Peripheral blood - all subjects | No intervention | –All subjects enrolled in arms 1 and 2. Do children have a more robust innate immune response to prevent biofilm infection? |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Ages 2 yrs. and older
- 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)
- Thermal burns with ≥20% TBSA
Key exclusion criteria (9 listed)
- Patients with chemical or electrical burns
- Pregnant women
- Patient/legal guardian/or next of kin unable to consent
- Immunosuppressed
- Taking immune modifying medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procelleraburn dressing | Device | Immunocompromised with >=20% TBSA |
Primary outcome
Detection of biofilm infection in burns
Time frame: 4 weeks
Tissue biopsies will be tested for presence of bacteria using SEM and culture.
2 secondary outcomes
Assessing graft loss as a result of biofilm infection
Time frame: 4 weeks post grafting surgery
Burn depth measurement
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gayle M Gordillo, MD principal investigator
Indiana University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procellera in people with Thermal Burn and Wound, run by Gayle Gordillo at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of biofilm infection in burns (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.