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 Withdrawn at 4 sites in United States.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
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.
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).
5,085 studies on the registry are indexed under Wounds and Injuries; 849 are open to participants now.
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Inclusion Criteria (Aim 3 is included in all criteria):
Aim 1 and 2:
Aim 1:
Aim 2:
Exclusion Criteria (Aim 3 is included in all criteria):
Aim 1 and 2:
Aim 1:
Immunocompetent with 2-14% TBSA thermal burn subjects. Does biofilm infection result in conversion of partial-thickness burn wounds to full-thickness?
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
All subjects enrolled in arms 1 and 2. Do children have a more robust innate immune response to prevent biofilm infection?
burn dressing
Detection of biofilm infection in burns
Tissue biopsies will be tested for presence of bacteria using SEM and culture.
Time frame: 4 weeks
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
Burn depth measurement
Harmonic Ultrasound \& Doppler (HUSD) imaging will provide tissue depth expressed in relevant unit
Time frame: 4 weeks
Examining children vs adults for biofilm resistance
TNF-a measurement through cytokine assay (pg/ml)
Time frame: 2 weeks post grafting surgery
Plan to share: No
No publications or documents are linked to this record.
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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Gayle Gordillo