Compare Wound Sampling Methods Efficacy in Microbiology Culture

Microbial Colonization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06460025
• Other study ID #: Long2024-slough vs. swap
• Status: Active, not recruiting
• Start date: October 1, 2022
• Est. completion date: May 1, 2025

Study information

• Verified date: June 2024
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 131
• Est. completion date: May 1, 2025
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infected Wound
• Infections
• Microbial Colonization
• Wound Infection
• Wounds and Injuries

Locations

Country	Name	City	State
China	Peking University 3rd Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ? from The ? 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	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 ? from The ? 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	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