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OpenTrials
Completed

NCT Number: NCT02025816

RNAseq Analysis of Microbial Gene Expression in Necrotizing Soft Tissue Infections

Hypothesis: We hypothesize that RNAseq will allow us to learn more about the causative agents of necrotizing soft tissue infections (NSTI) and risk factors involved in acquiring these devastating infections

Tissue biopsies will be obtained from consented patients admitted with NSTI. Biopsies will be used for standard clinical analysis of bacterial species present or stored for later RNA sequencing. RNA sequencing will identify bacteria that are present within the infection site that may not be detected using standard culture techniques as well as reveal bacterial gene expression profiles within the NSTI site. Medical charts will also be reviewed for basic patient information as well as wound care management practices. We hope to identify bacterial species commonly present in these types of infections as well as risk factors predisposing individuals to NSTI's.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Texas Tech University Health Sciences Center/University Medical Center, Lubbock, Texas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient or LAR agrees to the procedure and signs informed consent form
  • Patient is at least 18 yrs of age
  • Patient has been diagnosed with an NSTI

Exclusion criteria

  • Patient not willing to undergo additional tissue biopsies for RNA sequencing analysis

Treatment and study plan

Primary outcomes

  1. Percentage of patients with non-culturable, anaerobic bacterial species colonization of NSTI

    Time frame: 2-6 wks (duration of hospitalization)

Sponsors and collaborators

Lead sponsor

Texas Tech University Health Sciences Center

Other

Registry information

Acronym: NSTI

Important dates

Study start
2013
Primary completion
2017
Study completion
2019
First posted
Jan 1, 2014
Registry last updated
Dec 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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