Recruiting

Wound Microbiome

Sponsor:

The University of Texas Medical Branch, Galveston

Code:

NCT05275335

Conditions

Microbial Colonization

Burns

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The purpose of this investigation is to better understand the wound microbiome in burn wounds and the role it plays in outcomes and complications related to treatment.

Conditions

Microbial Colonization

Burns

Study ID

NCT05275335

Start date

Nov 1, 2022

Status verified date

Aug, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • All adult patients (18 years of age and greater) admitted to or consulted by the Acute Burn Surgery service with a diagnosis of a partial thickness or full thickness burn wound determined by the Acute Burn Surgery service to be appropriate for operative intervention. We will include patients 18 years of age and older of any gender, race, prior therapy, or pre-existing medical condition. We will also include subjects in special classes, including pregnant women and cognitively impaired persons.

Exclusion Criteria:

  • Children (less than 18 years of age) will be excluded. Patients who do not undergo operative therapy or patients whose operative therapy does not involve tangential excision of burn wounds will also not be eligible for inclusion by virtue of not being able to provide appropriate biospecimens. Patients whose burn wounds are isolated to the genitalia and perineum will be excluded from the study. For patients who have multiple burn wounds including those to the genitalia and perineum, it should be noted that excised tissues from the genitalia and perineum are not eligible for inclusion to the Burn Wound Data/Bio-Repository. Finally, patients whose operative intervention results in less than a total of 4 grams of discarded tissue will be excluded due to insufficient specimen for proper tissue analysis. Any tissue allocated for pathology or that has already been physically discarded into a trash receptacle will not be eligible for inclusion in the Burn Wound Data/Bio-Repository. We will also exclude prisoners from this study.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Statistical correlation of the Next-Generation Sequenced microbiome to standard culture results in burn wounds [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Steven E Wolf, MD

12107870507swolf@utmb.edu

Locations

University of Texas Medical Branch

Recruiting

Galveston, Texas, United States, 77550

Contacts

Steven E Wolf, MD

210-787-0507swolf@utmb.edu

More Information

Sponsor

The University of Texas Medical Branch, Galveston

Last update posted

Aug 15, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Medical Branch, Galveston on 2025-08-15.