Compare Wound Sampling Methods Efficacy in Microbiology Culture

Active, not recruiting

• Conditions: Infected Wound; Slough; Microbial Colonization

• Registration Number: NCT06460025
• Lead Sponsor: Peking University Third Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-10-01
• Primary Completion: 2023-10-01
• Study First Submitted: 2024-05-26
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-10
• Last Update Submitted: 2024-06-10
• Study First Posted: 2024-06-14
• Last Update Posted: 2024-06-14
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 131

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;

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Peking University 3rd Hospital; 🇨🇳 Beijing, Beijing, China