Gender Disparity in Burn Injury Survival

Obesity Clinical Trial

Official title:

Gender Disparity in Burn Injury Survival

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02029768
• Other study ID #: L14-029
• Status: Terminated
• Start date: December 2013
• Est. completion date: June 28, 2017

Study information

• Verified date: December 2019
• Source: Texas Tech University Health Sciences Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: June 28, 2017
• Est. primary completion date: January 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Burn Injury
• Burns
• Obesity
• Wounds and Injuries

Locations

Country	Name	City	State
United States	Texas Tech University Health Sciences Center/University Medical Center	Lubbock	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Tech University Health Sciences Center	Laura W. Bush Institute for Women's Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory cytokine levels	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