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Microcirculatory Assessment in Patients With Trauma and Severe Burns

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ClinicalTrials.gov Identifier: NCT01922960
Recruitment Status : Withdrawn (investigators decided not to move forward with project)
First Posted : August 14, 2013
Last Update Posted : November 29, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
Predict the development of multiple organ failure in patients with trauma and severe burns.

Condition or disease Intervention/treatment
Burns Trauma Other: micro-imaging

Detailed Description:

Microvascular alterations are frequently seen in patients with sepsis, trauma, burns and those who are hemodynamically uncompensated(Shock).

The use of the Microscan is a non-invasive approach to visualize and assess impaired mucosal microcirculation in order to identify early on patients who are predisposed for MOF (multiple organ failure)

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Microcirculatory Assessment in Patients With Trauma and Severe Burns
Anticipated Study Start Date : April 7, 2012
Primary Completion Date : February 2014
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment

Sublingual or subconjunctival micro-imaging of the microcirculation taken for 3 minute intervals at certain timepoints.

Timepoints for burn/trauma subjects: Day0, Day1,Day2,Day6 & Day7 Timepoints for general surgery population: post-induction, prior to resection, after resection,& closing of surgical wound.

Other: micro-imaging

Outcome Measures

Primary Outcome Measures :
  1. dysfunctional capillary density correlates with development of multiple organ failure [ Time Frame: approximately 1 year to assess outcome measure ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with severe burns/trauma ages 19-80. Patients undergoing elective abdominal or cardiothoracic surgery ages 19-69 years old

Exclusion Criteria:

  • Patients undergoing elective surgery < 19 years old.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01922960

United States, Alabama
University of South Alabama Medical Center
Mobile, Alabama, United States, 36617
Sponsors and Collaborators
University of South Alabama
Study Chair: William O Richards, MD University of South Alabama, Department of Surgery
More Information

Responsible Party: William Richards, Study Chair and Principle Investigator, University of South Alabama
ClinicalTrials.gov Identifier: NCT01922960     History of Changes
Other Study ID Numbers: 12-092
First Posted: August 14, 2013    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017

Keywords provided by William Richards, University of South Alabama:
multiple organ dysfunction syndrome

Additional relevant MeSH terms:
Wounds and Injuries