Exploratory Study of Raised Serum Lactate as a Marker of Necrotizing Fasciitis
This study has been completed.
Information provided by (Responsible Party):
George Murphy, National Health Service, United Kingdom
First received: November 26, 2012
Last updated: November 28, 2012
Last verified: November 2012
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.
||Time Perspective: Prospective
||Raised Serum Lactate as a Marker of Necrotizing Fasciitis; a Consecutive Prospective Review.
Primary Outcome Measures:
- Serum lactate level [ Time Frame: At referral to the Plastic Surgery Team ] [ Designated as safety issue: No ]
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).
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2010 (Final data collection date for primary outcome measure)
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.
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.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01739959
|Wexham Park Hospital
|Slough, London, United Kingdom, SL2 4HL |
National Health Service, United Kingdom
||George Murphy, MRCS
||Wexham Park Hospital
No publications provided
||George Murphy, Principal Investigator, National Health Service, United Kingdom
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 26, 2012
||November 28, 2012
||United Kingdom: National Health Service
Keywords provided by National Health Service, United Kingdom:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Skin Diseases, Bacterial