Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06460025
Other study ID # Long2024-slough vs. swap
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT05414994 - Assessment of the Ocular Microbiome in Health and Disease
Completed NCT04769882 - Er:YAG Laser Effects on Microbial Population in Conservative Dentistry N/A
Completed NCT04766528 - Effect of Diet on the Microbiota / Endoccanabinoidome Axis in Response to Physical Activity N/A
Completed NCT03720314 - Microbiota Profiling in IBS
Completed NCT04122612 - Shaping Microbiome in the First 1,000 Days of Life
Not yet recruiting NCT05405634 - Microbiota in Chronic Anal Fissure and Its Association With Prognosis
Not yet recruiting NCT04895774 - Ex Vivo Study of the Mechanism of Action of Active Ingredients on the Intestinal Microbiota
Recruiting NCT05992688 - The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time) N/A
Recruiting NCT05502380 - Broad-spectrum Antibiotic Prophylaxis in Tumor and Infected Orthopedic Surgery Phase 3
Completed NCT05175833 - Oral Probiotics and Secondary Bacterial Pneumonia in Severe COVID-19 Phase 2
Recruiting NCT04836910 - Microbiome and Polycystic Ovaries
Recruiting NCT05603650 - Effects of Mouthrinses on the Microbiome of the Oral Cavity and GI Tract N/A
Completed NCT05575050 - Impact of Teeth Brushing in Ventilated COVID-19 Patients. N/A
Completed NCT04991818 - MSC - OneBiome UX Pilot Study N/A
Completed NCT04374955 - The Effect of Probiotic Added to Maternal Diet on Infantile Colic and Intestinal Microbiota Content N/A
Recruiting NCT04140747 - Transfer of Strictly Anaerobe Microbes From Mother to Child
Recruiting NCT04111471 - The Use of A Prebiotic to Promote a Healthy Gut Microbiome in Pediatric Stem Cell Transplant Recipients N/A
Suspended NCT03220282 - The Milk, Growth and Microbiota Study N/A
Completed NCT03422562 - Probiotics and Intestinal Microbiome in Preterm Infants Phase 3
Recruiting NCT05695196 - Feasibility and Safety Study of Parent-to-Child Nasal Microbiota Transplant Phase 1