Biofilm Infection in Adults and Children Burn Injury

NCT03248154 | Withdrawn

• 1 other identifier: 16-00244
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

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.

Conditions

Thermal Burn; Wound

Keywords

Biofilm; Procellera

Outcome Measures

Primary Outcomes (1)

• Detection of biofilm infection in burns

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

  4 weeks

Secondary Outcomes (2)

• Assessing graft loss as a result of biofilm infection

  4 weeks post grafting surgery

• Burn depth measurement

  4 weeks

Other Outcomes (1)

• Examining children vs adults for biofilm resistance

  2 weeks post grafting surgery

Study Arms (3)

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?

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?

Interventions

Procellera DEVICE

burn dressing

Immunocompromised with >=20% TBSA

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gayle Gordillo: lead
• Nationwide Children's Hospital: collaborator

Study Sites (4)

University Hospital East

Columbus, Ohio, 43203, United States

Location

Davis Heart and Lung Research Institute

Columbus, Ohio, 43210, United States

Location

The Ohio State University/Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Martha Morehouse Medical Plaza 2050 Kenny Road

Columbus, Ohio, 43221, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Gayle M Gordillo, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: August 14, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: January 4, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)