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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
George Murphy, National Health Service, United Kingdom
ClinicalTrials.gov Identifier:
NCT01739959
First received: November 26, 2012
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

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.


Condition
Fasciitis, Necrotizing

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Raised Serum Lactate as a Marker of Necrotizing Fasciitis; a Consecutive Prospective Review.

Resource links provided by NLM:


Further study details as provided by National Health Service, United Kingdom:

Primary Outcome Measures:
  • Serum lactate level [ Time Frame: At referral to the Plastic Surgery Team ] [ Designated as safety issue: No ]
    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).


Enrollment: 53
Study Start Date: September 2000
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01739959

Locations
United Kingdom
Wexham Park Hospital
Slough, London, United Kingdom, SL2 4HL
Sponsors and Collaborators
National Health Service, United Kingdom
Investigators
Principal Investigator: George Murphy, MRCS Wexham Park Hospital
  More Information

No publications provided

Responsible Party: George Murphy, Principal Investigator, National Health Service, United Kingdom
ClinicalTrials.gov Identifier: NCT01739959     History of Changes
Other Study ID Numbers: WPH/NF/2000-2010
Study First Received: November 26, 2012
Last Updated: November 28, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by National Health Service, United Kingdom:
Necrotizing fasciitis
Fournier's gangrene
Cellulitis
Serum Lactate

Additional relevant MeSH terms:
Fasciitis
Fasciitis, Necrotizing
Bacterial Infections
Musculoskeletal Diseases
Skin Diseases, Bacterial

ClinicalTrials.gov processed this record on November 20, 2014