Rapid Identification of Key Pathogens in Wound Infection by Molecular Means

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brentwood Biomedical Research Institute
ClinicalTrials.gov Identifier:
NCT00287599
First received: February 3, 2006
Last updated: February 7, 2012
Last verified: February 2012
  Purpose

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
Postoperative Wound Infection
Traumatic Wound Infection
Closed Soft Tissue Abscess

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Rapid Identification of Key Pathogens in Wound Infection by Molecular Means

Further study details as provided by Brentwood Biomedical Research Institute:

Biospecimen Retention:   Samples With DNA

Pus and tissue specimens


Enrollment: 400
Study Start Date: October 2006
Study Completion Date: August 2011
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Community sample

Criteria

Inclusion Criteria:

  • active postoperative or traumatic wound infection
  • soft tissue abscess

Exclusion Criteria:

  • no active infection
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00287599

Locations
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
Investigators
Principal Investigator: Sydney M Finegold, MD VA Medical Center-West Los Angeles
  More Information

No publications provided

Responsible Party: Brentwood Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT00287599     History of Changes
Other Study ID Numbers: W81XWHO510134
Study First Received: February 3, 2006
Last Updated: February 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Brentwood Biomedical Research Institute:
Surgical wound infections
Real-time PCR
Rapid identification of bacteria
Cloning
16S rRNA sequencing

Additional relevant MeSH terms:
Communicable Diseases
Infection
Surgical Wound Infection
Wound Infection
Pathologic Processes
Postoperative Complications
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014