Gender Disparity in Burn Injury Survival

Terminated

• Conditions: Obesity; Burn Injury

• Registration Number: NCT02029768
• Lead Sponsor: Texas Tech University Health Sciences Center

Brief Summary

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.

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 Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-01-02
• Study First Submitted QC: 2014-01-06
• Study First Posted: 2014-01-08
• Primary Completion: 2017-01-25
• Study Completion: 2017-06-28
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inflammatory cytokine levels	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

Trial Locations

Locations (1)

Texas Tech University Health Sciences Center/University Medical Center; 🇺🇸 Lubbock, Texas, United States