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

NCT01739959 | Completed

• 1 other identifier: WPH/NF/2000-2010
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Fasciitis, Necrotizing

Keywords

Necrotizing fasciitis; Fournier's gangrene; Cellulitis; Serum Lactate

Outcome Measures

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).

  At referral to the Plastic Surgery Team

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Nil

Sponsors & Collaborators

• National Health Service, United Kingdom: lead

Study Sites (1)

Wexham Park Hospital

Slough, London, SL2 4HL, United Kingdom

Location

MeSH Terms

Conditions

Fasciitis, Necrotizing; Fournier Gangrene; Cellulitis

Condition Hierarchy (Ancestors)

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

Study Officials

• George Murphy, MRCS

  Wexham Park Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: December 4, 2012
• Study Start: September 1, 2000
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: December 4, 2012

Record last verified: 2012-11

Locations

GB (1)