NCT05275335

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Nov 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Nov 2022Dec 2026

First Submitted

Initial submission to the registry

February 11, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

August 15, 2025

Status Verified

August 1, 2025

Enrollment Period

4.2 years

First QC Date

February 11, 2022

Last Update Submit

August 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Statistical correlation of the Next-Generation Sequenced microbiome to standard culture results in burn wounds

    The relationship between next-generation sequencing of the burn wound microbiome and traditional clinical culture techniques will be examined. In particular, comparisons will compare the bacterial microbiota of each sample with bacteria identified using standard clinical culture methods from the same sample. Correlations in taxonomic diversity will be done with linear regression and Pearson correlation.

    3 years

Secondary Outcomes (1)

  • Clinical predictors of microbiome taxonomy

    3 years

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult burn patients with excised burn eschar

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77550, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Excised and discarded burn wound eschar with microbial DNA analysis

MeSH Terms

Conditions

Communicable DiseasesBurns

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Steven E Wolf, MD

    University of Texas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven E Wolf, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2022

First Posted

March 11, 2022

Study Start

November 1, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 15, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations