Compare Wound Sampling Methods Efficacy in Microbiology Culture

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Microbial Colonization; Infected Wound; Slough

• Study Type: Observational
• Enrollment (Actual): 131

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 010
      • Peking University 3rd Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

This was a single-center, retrospective, cross-sectional study, including 131 patients with acute or chronic wounds treated in Wound Healing Center of Peking University Third Hospital from October 2022 to October 2023

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
slough; slough as the wound specimen for microbiology cultivation
swap; swap as the wound specimen for microbiology cultivation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cohen's k coefficient of Gram Stain between Slough and Swap Specimens	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.	Day 0, patients' the first site in wound healing center

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cohen's k coefficient of Common pathogens between Slough and Swap Specimens	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.	Day 0, patients' the first site in wound healing center
agreements in microbiology cultivation between slough and swap	compare the agreement of pathogens after bacterial culture between Slough and Swap Specimens, by percentage.	Day 0, patients' the first site in wound healing center

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: May 26, 2024
• First Submitted That Met QC Criteria: June 10, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Biofilm; Sampling; Microbial Colonization; Infected Wound; Slough
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Wounds and Injuries; Wound Infection
• Other Study ID Numbers: Long2024-slough vs. swap

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No