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Association of Cytokines With the Development of Complications in Burn and Toxic Epidermal Necrolysis (TENS) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04252651
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Joseph M. Still Research Foundation, Inc.

Brief Summary:
This study will involve blood draws to test for specific cytokines. The study goal is to gain a better understanding of the role of inflammatory response in the development of specific complications in burn and TENS patients.

Condition or disease Intervention/treatment
Inflammatory Response Multi Organ Failure Nosocomial Infection Deep Vein Thrombosis Other: Blood Draw

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Study Type : Observational
Estimated Enrollment : 65 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Association of Cytokines With the Development of Complications in Burn and Toxic Epidermal Necrolysis (TENS) Patients
Actual Study Start Date : October 2, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020


Group/Cohort Intervention/treatment
Blood Draw
This study will involve blood draws to test for specific cytokines
Other: Blood Draw
This study will involve blood draws to test for specific cytokines




Primary Outcome Measures :
  1. Cytokine Response that develops into complications [ Time Frame: up to one year ]
    The number of burn and TENS patients that develop subsequent medical complications


Biospecimen Retention:   Samples Without DNA
Plasma


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Samples size will be patients from the burn ICU.
Criteria

Inclusion Criteria:

  • is ≥18 years of age
  • has been admitted to the Joseph M. Still Burn Center at Doctors Hospital Augusta with a burn diagnosis, or TENS OR SJS diagnosis (confirmed or non-confirmed), with an expected length of stay to be at least 7 days
  • the subject or their legally authorized representative is able to provide informed consent
  • has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy)

Exclusion Criteria:

  • is moribund, or in the opinion of the investigator is not expected to survive
  • has sustained an electrical burn

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252651


Contacts
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Contact: Joan Wilson 7063642966 joan.wilson@jmsresearchfoundation.org

Locations
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United States, Georgia
Joseph M. Still Burn Center at Doctors Hospital Recruiting
Augusta, Georgia, United States, 30909
Contact: Joan Wilson    706-364-2966    joan.wilson@jmsresearchfoundation.org   
Principal Investigator: Michael Quinn, MD         
Sub-Investigator: Marcos Aranda, MD         
Sub-Investigator: Anna Elseth, DO         
Sub-Investigator: Constance Joel, MD         
Sub-Investigator: Balakrishna Prasad, MD         
Sponsors and Collaborators
Joseph M. Still Research Foundation, Inc.
Investigators
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Principal Investigator: Michael Quinn, MD Joseph M. Still Research Foundation, Inc.
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Responsible Party: Joseph M. Still Research Foundation, Inc.
ClinicalTrials.gov Identifier: NCT04252651    
Other Study ID Numbers: JMSRF-CYT-P04
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Study results will be analyzed, and study data presented at an appropriate related Congress meeting. Journal publication in a related peer-reviewed journal would be expected after presentation.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cross Infection
Stevens-Johnson Syndrome
Thrombosis
Venous Thrombosis
Multiple Organ Failure
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Shock
Stomatitis
Mouth Diseases
Stomatognathic Diseases
Drug Eruptions
Dermatitis
Skin Diseases
Erythema Multiforme
Erythema
Skin Diseases, Vesiculobullous
Drug Hypersensitivity
Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders