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

Fasciitis, Necrotizing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01739959
• Other study ID #: WPH/NF/2000-2010
• Status: Completed
• Phase: N/A
• First received: November 26, 2012
• Last updated: November 28, 2012
• Start date: September 2000
• Est. completion date: September 2010

Study information

• Verified date: November 2012
• Source: National Health Service, United Kingdom
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Necrotizing

Locations

Country	Name	City	State
United Kingdom	Wexham Park Hospital	Slough	London

Sponsors (1)

Lead Sponsor	Collaborator
National Health Service, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No