The sensitivity and specificity of Gram stain on formalin fixed tissue sections in the diagnosis of bacterial skin infection - a study of diagnostic test accuracy

Not Applicable

Completed

• Conditions: Bacterial skin infection; Skin - Dermatological conditions; Infection - Studies of infection and infectious agents

• Registration Number: ACTRN12621001637831
• Lead Sponsor: Brendan Stagg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-30
• Study Completion: 2022-10-10
• Last Update Posted: 4 December 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 163

Inclusion Criteria

This study will include a retrospective consecutive series of all cases encountered at SA Pathology from 4th September 2017 wherein skin tissue specimens were concurrently submitted for histological and microbiological assessment, provided histological assessment included use of Gram stain. SA Pathology is the public pathology provider for South Australia, serving patients across all age groups, and serving patients in both inpatient and outpatient settings.

Exclusion Criteria

Cases will be excluded is the Gram stain result was not described in the anatomical pathology report, or if the patient was diagnosed with bacterial infection due to a pathogen which cannot reasonably be identified using Gram stain (e.g. mycobacteria).

Study & Design

• Study Type: Observational
• Study Design: Not specified