Microbial ColonizationNCT06460025
Compare Wound Sampling Methods Efficacy in Microbiology Culture
An observational study of Microbial Colonization and Infected Wound, run by Peking University Third Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Microbial Colonization, Infected Wound, Slough
- How many people
- 131 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Microbial Colonization, Infected Wound, Slough
- Keywords
- Microbial Colonization, Infected Wound, Slough, Biofilm, Sampling
- Medical subject headings
- Communicable Diseases, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| slough | slough as the wound specimen for microbiology cultivation | |
| swap | swap as the wound specimen for microbiology cultivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: Day 0, patients' the first site in wound healing center
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 Oct 2022
- Primary completion1 Oct 2023
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Long Zhang, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460025
- Sponsor's protocol ID
- Long2024-slough vs. swap
- Status last verified
- Jun 2024
- First submitted
- 26 May 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39924720
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Slough in Acute or Chronic Wounds for the Diagnosis of Microbiology Cultivation
- ClinicalTrials.gov ID
- NCT06460025
- Acronym / sponsor ID
- Long2024-slough vs. swap
- Conditions
- Microbial Colonization, Infected Wound, Slough
- Keywords
- Microbial Colonization, Infected Wound, Slough, Biofilm, Sampling
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| slough | – | –slough as the wound specimen for microbiology cultivation |
| swap | – | –swap as the wound specimen for microbiology cultivation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
cohen's k coefficient of Gram Stain between Slough and Swap Specimens
Time frame: 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.
2 secondary outcomes
cohen's k coefficient of Common pathogens between Slough and Swap Specimens
Time frame: Day 0, patients' the first site in wound healing center
agreements in microbiology cultivation between slough and swap
Time frame: Day 0, patients' the first site in wound healing center
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Derived from this study: PubMed 39924720Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microbial Colonization and Infected Wound, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cohen's k coefficient of Gram Stain between Slough and Swap Specimens (time frame: Day 0, patients' the first site in wound healing center). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06460025, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.