Compare Wound Sampling Methods Efficacy in Microbiology Culture

Slough in Acute or Chronic Wounds for the Diagnosis of Microbiology Cultivation

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06460025

Enrollment

131

Registered

2024-06-14

Start date

2022-10-01

Completion date

2025-05-01

Last updated

2024-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infected Wound, Microbial Colonization, Slough

Keywords

Microbial Colonization, Infected Wound, Slough, Biofilm, Sampling

Brief summary

Slough was a visible indicator of biofilm, which was the most available specimen from acute and chronic wounds. However, studies believed that slough were poorly accurate, and that the Levine swab was more recommended for sampling bacterial culture. This study aimed to compare slough with swab sample and analyze the consistency.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients with acute and chronic wounds who were first seen at the Wound Care Centre of Peking University Third Hospital from October 2022 to October 2023; 2. Patients who have followed the wound sample collection SOP to simultaneously take wound swabs and putrefactive samples and send them for bacterial culture;; 3. Patients aged 18 years or older;

Exclusion criteria

1. Patients who had been taken only one of the wound samples, either swab or slough; 2. The swab collection did not meet the deifinitions for the exudate method or the Levine technique； 3. Bacterial culture profile was incomplete didn't meet the requirement of the trial.

Design outcomes

Primary

Measure	Time frame	Description
cohen's k coefficient of Gram Stain between Slough and Swap Specimens	Day 0, patients' the first site in wound healing center	compare the difference of Gram Stain after bacterial culture between Slough and Swap Specimens, by using statistics of cohen's k coefficient，values of κ from The κ coefficients in 0.81 to 1 waeres interpreted as excellentalmost perfect concordance, with 0.61 to 0.80 asrepresented substantial, 0.41 to 0.60 as mean moderate, 0.21 to 0.40 as fair, and 0 to 0.20 as slight.

Secondary

Measure	Time frame	Description
cohen's k coefficient of Common pathogens between Slough and Swap Specimens	Day 0, patients' the first site in wound healing center	compare the difference of Common pathogens after bacterial culture between Slough and Swap Specimens, by using statistics of cohen's k coefficient，values of κ from The κ coefficients in 0.81 to 1 waeres interpreted as excellentalmost perfect concordance, with 0.61 to 0.80 asrepresented substantial, 0.41 to 0.60 as mean moderate, 0.21 to 0.40 as fair, and 0 to 0.20 as slight.
agreements in microbiology cultivation between slough and swap	Day 0, patients' the first site in wound healing center	compare the agreement of pathogens after bacterial culture between Slough and Swap Specimens, by percentage.

Countries

China

Outcome results