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CompletedNCT01739959Updated Dec 4, 2012

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

An observational study in Fasciitis, Necrotizing, sponsored by National Health Service, United Kingdom. Completed at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2012-12-04.

Sponsored by National Health Service, United Kingdom · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
53
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Fasciitis, Necrotizing

Keywords

  • Necrotizing fasciitis
  • Fournier's gangrene
  • Cellulitis
  • Serum Lactate
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In context

Fasciitis, Necrotizing

28 studies on the registry are indexed under Fasciitis, Necrotizing; 8 are open to participants now.

This study's enrollment of 53 is below the median of 152 across 16 observational studies indexed under Fasciitis, Necrotizing.

Browse Fasciitis, Necrotizing studies →

Lead sponsor

National Health Service, United Kingdom is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Nil
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Study design

Time perspective
Prospective
Enrollment
53 participants (actual)

Groups and 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.

06

What researchers measure

Primary outcomes

  1. Serum lactate level

    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).

    Time frame: At referral to the Plastic Surgery Team

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Study locations

1 site
  • Wexham Park Hospital
    Slough, London SL2 4HL, United Kingdom
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01739959
Lead sponsor
National Health Service, United Kingdom
Responsible party
George Murphy (Principal Investigator, National Health Service, United Kingdom) — Principal investigator
First posted
Dec 4, 2012
Start date
Sep 2000
Primary completion
Sep 2010
Completion
Sep 2010
Last update
Dec 4, 2012

Study contacts

George Murphy, MRCS
principal investigator · Wexham Park Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2012. You cannot join it, but the record below documents what was studied.

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