Gender Disparity in Burn Injury Survival

December 11, 2019 updated by: Texas Tech University Health Sciences Center

Hypothesis 1: A quantifiable difference in inflammatory cytokines exist in women with burn injury and this correlates with clinical markers of outcome

Hypothesis 2: The amount of adipose tissue contributes to the severity of cellular immune response (CMI) dysregulation in response to burn injury

Skin-fold caliper measurements will be taken on consented patients (both male and female) to determine body fat percentage. Serum samples will be obtained from these patients. The level of inflammatory cytokines in the serum will be measured to determine if there is a link between body fat percentage, pro-inflammatory cytokines and the ability of women to survive burn injury.

Study Overview

Status

Terminated

Conditions

Detailed Description

Consented patients admitted to University Medical Center with greater than 15% total body surface area burns will participate in this study. A skin-fold caliper measurement will be performed to determine body fat percentage. Serum samples will be obtained and assayed for inflammatory cytokines to establish whether or not a link between obesity in women and pro-inflammatory cytokines exists. If so, obesity may be a factor which contributes to the gender disparity in burn wound survival.

Study Type

Observational

Enrollment (Actual)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Lubbock, Texas, United States, 79430
        • Texas Tech University Health Sciences Center/University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Study population will be derived from adult patients admitted to the University Medical Center with greater than 15% total body surface area burns

Description

Inclusion Criteria:

  • Men and women ages 18 to 65 years
  • Admitted to University Medical Center with greater than 15% total body surface area burns
  • Able to provide informed consent or has authorized representative to give informed consent

Exclusion Criteria:

  • Prisoners or pregnant women
  • Individuals with injuries that preclude taking caliper measurements

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Women with burn injury
Men with burn injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory cytokine levels
Time Frame: 72 hours post admission until patient discharge
We will measure inflammatory cytokine levels and determine if elevated cytokine levels are linked to obesity and ultimately burn injury survival
72 hours post admission until patient discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Tech University Health Sciences Center

Collaborators

Laura W. Bush Institute for Women's Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Actual)

January 25, 2017

Study Completion (Actual)

June 28, 2017

Study Registration Dates

First Submitted

January 2, 2014

First Submitted That Met QC Criteria

January 6, 2014

First Posted (Estimate)

January 8, 2014

Study Record Updates

Last Update Posted (Actual)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 11, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L14-029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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