Recruiting

Observational Study

Sponsor:

University of South Alabama

Code:

NCT01812941

Conditions

Burns

Trauma

Eligibility Criteria

Sex: All

Age: 19 - 70

Healthy Volunteers: Accepted

Interventions

trauma: blood collection

healthy volunteers: blood collection

Burn: blood collection

Study Details

Brief summary:

The purpose of this project is to evaluate the level of mitochondrial dysfunction several patient populations: Burn, trauma, and control group of healthy volunteers.

Study hypothesis: Increased plasma concentrations of a newly discovered inflammatory mediated, called mtDNA DAMPS associated with the occurrence of multi-organ dysfunction syndrome in severly injured patients.

As the severity of a burn injury or trauma injury increase, so will systemic mitochondrial dysfunction.

Conditions

Burns

Trauma

Study ID

NCT01812941

Start date

Sep, 2011

Status verified date

May, 2021

Completion date

Dec, 2021

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Burn injury must be less than 24 hours old at time of initial sampling
  • Burn must be 2nd or 3rd degree and at least 10% TBSA
  • ISS (injury severity score) > 15

Exclusion Criteria:

  • Burn injury/trauma injury > than 24hours old at time of initial sampling
  • Burn < 10% total body surface area.
  • Evidence of active infection on admission in the burn subjects.
  • < 19 years of age and > 70 years

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Factorial

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Burn: blood collection

Procedure: Blood draws as the intervention.

other: trauma: blood collection

blood to be collected at different time intervals. Blood draw as the intervention

other: healthy volunteers: blood collection

Blood draws as the intervention

Interventions

trauma: blood collection

Blood samples collected at certain timepoints. Time points for burn/trauma subjects: Day0,Day1,Day2,and Day6 and Day7.

healthy volunteers: blood collection

blood collected at designated time intervals

Burn: blood collection

blood collected at designated time intervals

Primary outcome measure

  • Plasma mtDNA DAMPs concentration [ Time Frame: approximately 1 year to assess outcome measure ]

Central Contacts and Locations

Central contacts

Jon Simmons, MD

251-471-7971jdsimmons@health.southalabama.edu

Mark Gillespie, PHD

251-460-6497mgillesp@southalabama.edu

Locations

University of South Alabama Medical Center

Recruiting

Mobile, Alabama, United States, 36617

Contacts

Jon Simmons, MD

251-471-7971jdsimmons@southalabama.edu

Mark Gillespie, PHD

251-460-6497mgillesp@southalabama.edu

Principal Investigator:

Jon Simmons, MD

More Information

Sponsor

University of South Alabama

Last update posted

May 28, 2021

Last verified

May, 2021

Keywords

  • burns
  • trauma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Alabama on 2021-05-28.