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

NCT ID: NCT01739959

Last Updated: 2012-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

53 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-09-30

Study Completion Date

2010-09-30

Brief Summary

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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

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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.

Conditions

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Fasciitis, Necrotizing

Keywords

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Necrotizing fasciitis Fournier's gangrene Cellulitis Serum Lactate

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Necrotizing fasciitis proven

Histological evidence of necrotizing fasciitis at initial surgical debridement

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Health Service, United Kingdom

OTHER_GOV

Sponsor Role lead

Responsible Party

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George Murphy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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George Murphy, MRCS

Role: PRINCIPAL_INVESTIGATOR

Wexham Park Hospital

Locations

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Wexham Park Hospital

Slough, London, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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WPH/NF/2000-2010

Identifier Type: -

Identifier Source: org_study_id