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

NCT04252651 | Unknown

• 1 other identifier: JMSRF-CYT-P04
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Response; Multi Organ Failure; Nosocomial Infection; Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

• Cytokine Response that develops into complications

  The number of burn and TENS patients that develop subsequent medical complications

  up to one year

Study Arms (1)

Blood Draw

This study will involve blood draws to test for specific cytokines

Other: Blood Draw

Interventions

Blood Draw OTHER

This study will involve blood draws to test for specific cytokines

Blood Draw

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Samples size will be patients from the burn ICU.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Joseph M. Still Research Foundation, Inc.: lead

Study Sites (1)

Joseph M. Still Burn Center at Doctors Hospital

Augusta, Georgia, 30909, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Multiple Organ Failure; Cross Infection; Venous Thrombosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Iatrogenic Disease; Disease Attributes; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Michael Quinn, MD

  Joseph M. Still Research Foundation, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joan Wilson

CONTACT

7063642966; joan.wilson@jmsresearchfoundation.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: February 5, 2020
• Study Start: October 2, 2019
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)