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

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.

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Key information

Conditions

Fasciitis, Necrotizing Bacterial Infections Bacterial Infections and Mycoses Cellulitis Connective Tissue Diseases Fasciitis Fournier Gangrene Genital Diseases Genital Diseases, Male Infections Inflammation Male Urogenital Diseases Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Wexham Park Hospital

Slough, London, SL2 4HL, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

National Health Service, United Kingdom

Other Gov

Registry information

Official study title

Raised Serum Lactate as a Marker of Necrotizing Fasciitis; a Consecutive Prospective Review.

Important dates

Study start: 2000
Primary completion: 2010
Study completion: 2010
First posted: Dec 4, 2012
Registry last updated: Dec 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed