Compare Wound Sampling Methods Efficacy in Microbiology Culture

NCT06460025 | Active Not Recruiting DMC

• 1 other identifier: Long2024-slough vs. swap
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbial Colonization; Infected Wound; Slough

Keywords

Microbial Colonization; Infected Wound; Slough; Biofilm; Sampling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• cohen's k coefficient of Common pathogens between Slough and Swap Specimens

  Day 0, patients' the first site in wound healing center

• agreements in microbiology cultivation between slough and swap

  Day 0, patients' the first site in wound healing center

Study Arms (2)

slough

slough as the wound specimen for microbiology cultivation

swap

swap as the wound specimen for microbiology cultivation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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;
• Patients who have followed the wound sample collection SOP to simultaneously take wound swabs and putrefactive samples and send them for bacterial culture;;
• Patients aged 18 years or older;

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University 3rd Hospital

Beijing, Beijing Municipality, 010, China

Location

Related Publications (1)

• Li Y, Cai M, Li N, Zhang H, Huang E, Zhao J, Jin M, Zhang L. The value of slough in wounds for the diagnosis of microbiology cultivation. Wound Repair Regen. 2025 Jan-Feb;33(1):e70002. doi: 10.1111/wrr.70002.

  PMID: 39924720 DERIVED

MeSH Terms

Conditions

Communicable Diseases; Wound Infection

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Head of Wound Healing Center

Study Record Dates

• First Submitted: May 26, 2024
• First Posted: June 14, 2024
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: May 1, 2025
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

CN (1)