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Rapid Identification of Key Pathogens in Wound Infection by Molecular Means

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00287599
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : February 8, 2012
Information provided by (Responsible Party):
Brentwood Biomedical Research Institute

Brief Summary:

The military is subject to traumatic wounds of various types and severity. Such wounds are predisposed to infection because they 1) tend to be extensive and deep, 2) may affect areas of normal carriage of potentially pathogenic bacteria in the gastrointestinal tract, upper respiratory tract, and the female genital tract, 3) typically produce tissue damage, 4) may introduce foreign bodies, 5) may interfere with local blood supply, 6) tend to produce ischemia, edema and hemorrhage, 7) may be complicated by fractures or burns and 8) may lead to shock and overwhelming of the body's systemic defenses. It will not always be possible in the military setting to cleanse and debride the wound promptly and effectively or to promptly provide surgery in the event of damage to vital structures. In the active military setting, the probability of wound infection following trauma is relatively high. In the absence of rapid identification of infecting flora and provision of information on antimicrobial susceptibility, clinicians must resort to empiric therapy rather than a tailored therapy. There is a tendency to use one of the top available agents that would likely be active against the vast majority of bacteria. This leads to increases in antimicrobial resistance, an important problem.

The investigators hypothesize that the use of molecular biology techniques will provide identification of the microorganisms responsible for wound infection more rapidly and accurately. The investigators will evaluate real-time PCR (polymerase chain reaction) technique under this proposal. This procedure can be applied directly to material from the wound without need for first growing the organisms. It can be used to define the total flora of the wound within five hours. The investigators will first develop primers and probes that will detect the various bacteria anticipated in a given wound in a certain location. These primers and probes will be used in real-time PCR for rapid and accurate identification of the wound flora. The information obtained with real-time PCR is quantitative so that one may judge the relative importance of different isolates. The investigators will also use another molecular approach, 16S rRNA gene cloning, and conventional cultures; these will provide further information about the flora of various wounds. Definitive identification of anaerobes can be provided quickly and that, along with information on usual antimicrobial susceptibility patterns, can be life-saving or shorten the course of the infection considerably.

Condition or disease
Postoperative Wound Infection Traumatic Wound Infection Closed Soft Tissue Abscess

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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Rapid Identification of Key Pathogens in Wound Infection by Molecular Means
Study Start Date : October 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Biospecimen Retention:   Samples With DNA
Pus and tissue specimens

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Community sample

Inclusion Criteria:

  • active postoperative or traumatic wound infection
  • soft tissue abscess

Exclusion Criteria:

  • no active infection

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 identifier (NCT number): NCT00287599

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United States, California
Sydney Finegold
Los Angeles, California, United States, 90073
Robert S Bennion MD
Sylmar, California, United States, 91342
Sponsors and Collaborators
Brentwood Biomedical Research Institute
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Principal Investigator: Sydney M Finegold, MD VA Medical Center-West Los Angeles
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Responsible Party: Brentwood Biomedical Research Institute Identifier: NCT00287599    
Other Study ID Numbers: W81XWHO510134
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: February 8, 2012
Last Verified: February 2012
Keywords provided by Brentwood Biomedical Research Institute:
Surgical wound infections
Real-time PCR
Rapid identification of bacteria
16S rRNA sequencing
Additional relevant MeSH terms:
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Communicable Diseases
Wound Infection
Surgical Wound Infection
Wounds and Injuries
Pathologic Processes
Postoperative Complications