Biofilm Infection in Adults and Children Burn Injury

Wound Clinical Trial

Official title:

Burn Biofilm Infection in Adults and Children

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03248154
• Other study ID #: 16-00244
• Status: Withdrawn
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 2022

Study information

• Verified date: December 2021
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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'. 300 subjects from 3 different age groups will be enrolled in 3 arms.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Thermal Burn
• Wound

Intervention

Device:
• Procellera
burn dressing

Locations

Country	Name	City	State
United States	Davis Heart and Lung Research Institute	Columbus	Ohio
United States	Martha Morehouse Medical Plaza 2050 Kenny Road	Columbus	Ohio
United States	The Ohio State University/Ohio State University Wexner Medical Center	Columbus	Ohio
United States	University Hospital East	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Gayle Gordillo	Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Examining children vs adults for biofilm resistance	TNF-a measurement through cytokine assay (pg/ml)	2 weeks post grafting surgery
Primary	Detection of biofilm infection in burns	Tissue biopsies will be tested for presence of bacteria using SEM and culture.	4 weeks
Secondary	Assessing graft loss as a result of biofilm infection	TEWL measurement (g/square meter/h) as an indicator of lost barrier function	4 weeks post grafting surgery
Secondary	Burn depth measurement	Harmonic Ultrasound & Doppler (HUSD) imaging will provide tissue depth expressed in relevant unit	4 weeks