Gender Disparity in Burn Injury Survival

NCT ID: NCT02029768

Last Updated: 2019-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-06-28

Brief Summary

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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

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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.

Conditions

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Obesity Burn Injury

Keywords

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outcome

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Women with burn injury

No interventions assigned to this group

Men with burn injury

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Laura W. Bush Institute for Women's Health

UNKNOWN

Sponsor Role collaborator

Texas Tech University Health Sciences Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Texas Tech University Health Sciences Center/University Medical Center

Lubbock, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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L14-029

Identifier Type: -

Identifier Source: org_study_id