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Trial record 7 of 17 for:    Necrotizing Fascitis

Exploratory Study of Raised Serum Lactate as a Marker of Necrotizing Fasciitis

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ClinicalTrials.gov Identifier: NCT01739959
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : December 4, 2012
Sponsor:
Information provided by (Responsible Party):
George Murphy, National Health Service, United Kingdom

Tracking Information
First Submitted Date November 26, 2012
First Posted Date December 4, 2012
Last Update Posted Date December 4, 2012
Study Start Date September 2000
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 28, 2012)
Serum lactate level [ Time Frame: At referral to the Plastic Surgery Team ]
Serum lactate level at initial referral to the plastic surgery team, as measured by arterial blood gas analysis (calibrated point-of-care testing). Levels compared between the group with confirmed histological necrosis at initial surgical debridement, versus those with no evidence of necrosis (a composite of those who did not undergo surgery as they were judged not to have necrotizing fasciitis, and those who did undergo surgery, but whose histology did not show tissue necrosis).
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Exploratory Study of Raised Serum Lactate as a Marker of Necrotizing Fasciitis
Official Title Raised Serum Lactate as a Marker of Necrotizing Fasciitis; a Consecutive Prospective Review.
Brief Summary The investigators examined the hypothesis that serum lactate is raised in early necrotizing fasciitis to a much greater extent than in other differential diagnoses, such as severe cellulitis, and therefore provides a diagnostic indicator.
Detailed Description A prospective comparison of serum lactate levels at referral to the Plastic Surgery team to the 'gold standard' test of histology at initial surgical debridement, looking at 53 consecutive patients referred with suspected necrotizing fasciitis to a single surgeon at one institution between 2000 and 2010.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients referred to a single surgeon at one institution over 10 years (September 2000 - September 2010) with a suspected diagnosis of necrotizing fasciitis. Patients were followed for the duration of their hospital stay.
Condition Fasciitis, Necrotizing
Intervention Not Provided
Study Groups/Cohorts
  • Necrotizing fasciitis proven
    Histological evidence of necrotizing fasciitis at initial surgical debridement
  • Not necrotizing fasciitis
    A composite of those with no histological tissue necrosis at initial surgical debridement, and those clinically judged not to be a necrotizing infection who therefore did not undergo surgery.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 28, 2012)
53
Original Actual Enrollment Same as current
Actual Study Completion Date September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Referral to one consultant (Mr A Armstrong) at one institution (Wexham Park Hospital) with a suspected diagnosis of necrotizing fasciitis between September 2000 and September 2010

Exclusion Criteria:

  • Nil
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01739959
Other Study ID Numbers WPH/NF/2000-2010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party George Murphy, National Health Service, United Kingdom
Study Sponsor National Health Service, United Kingdom
Collaborators Not Provided
Investigators
Principal Investigator: George Murphy, MRCS Wexham Park Hospital
PRS Account National Health Service, United Kingdom
Verification Date November 2012