Microcirculatory Assessment in Patients With Trauma and Severe Burns

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2013 by University of South Alabama.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
William Richards, University of South Alabama
ClinicalTrials.gov Identifier:
First received: June 27, 2013
Last updated: August 12, 2013
Last verified: August 2013
Predict the development of multiple organ failure in patients with trauma and severe burns.

Condition Intervention
Other: micro-imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Microcirculatory Assessment in Patients With Trauma and Severe Burns

Resource links provided by NLM:

Further study details as provided by University of South Alabama:

Primary Outcome Measures:
  • dysfunctional capillary density correlates with development of multiple organ failure [ Time Frame: approximately 1 year to assess outcome measure ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions

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

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)


Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01922960

Contact: William O Richards, MD 251-471-7993 brichards@usouthal.edu

United States, Alabama
University of South Alabama Medical Center Recruiting
Mobile, Alabama, United States, 36617
Contact: William O. Richards, MD    251-471-7993    brichards@usouthal.edu   
Principal Investigator: William O. Richards, MD         
Sub-Investigator: Diego Alvarez, PhD         
Sponsors and Collaborators
University of South Alabama
Study Chair: William O Richards, MD University of South Alabama, Department of Surgery
  More Information

No publications provided

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
Study First Received: June 27, 2013
Last Updated: August 12, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on November 27, 2015