Biofilm Infection in Adults and Children Burn Injury

Not Applicable

Withdrawn

• Conditions: Wound; Thermal Burn

• Registration Number: NCT03248154
• Lead Sponsor: Gayle Gordillo

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).

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-02-08
• Study First Submitted QC: 2017-08-09
• Study First Posted: 2017-08-14
• Status Verified: 2021-12
• Primary Completion: 2021-12
• Last Update Submitted: 2021-12-13
• Last Update Posted: 2022-01-04
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Detection of biofilm infection in burns	4 weeks	Tissue biopsies will be tested for presence of bacteria using SEM and culture.

Secondary Outcome Measures

Name	Time	Method
Assessing graft loss as a result of biofilm infection	4 weeks post grafting surgery	TEWL measurement (g/square meter/h) as an indicator of lost barrier function
Burn depth measurement	4 weeks	Harmonic Ultrasound \& Doppler (HUSD) imaging will provide tissue depth expressed in relevant unit

Trial Locations

Locations (4)

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