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

• Sponsor: Joseph M. Still Research Foundation, Inc. (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04252651
• Collaborator: (none)
• Enrollment: 65
• Location: 1
• Anticipated Duration (Months): 38
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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	Phase
Inflammatory Response; Multi Organ Failure; Nosocomial Infection; Deep Vein Thrombosis	Other: Blood Draw

Study Design

• Study Type: Observational
• Anticipated 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: Oct 2, 2019
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Cytokine Response that develops into complications [up to one year]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Joseph M. Still Burn Center at Doctors Hospital	Augusta	Georgia	United States	30909

Sponsors and Collaborators

• Joseph M. Still Research Foundation, Inc.

Investigators

• Principal Investigator: Michael Quinn, MD, Joseph M. Still Research Foundation, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joseph M. Still Research Foundation, Inc.
• ClinicalTrials.gov Identifier: NCT04252651
• Other Study ID Numbers: JMSRF-CYT-P04
• First Posted: Feb 5, 2020
• Last Update Posted: Aug 25, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cross Infection; Stevens-Johnson Syndrome; Thrombosis; Venous Thrombosis; Multiple Organ Failure

Study Results

No Results Posted as of Aug 25, 2021