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A single-center clinical study of wound infection diagnosis based on self-developed near infrared spectral imager

A single-center clinical study of wound infection diagnosis based on self-developed near infrared spectral imager

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200057238
Enrollment
Unknown
Registered
2022-03-04
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

All kinds of acute and chronic wounds

Interventions

Gold Standard:Traditional Microbial Culture Identification and Pathological Detection
Index test:Near infrared spectroscopy: wound bacteria species, quantity, drug resistance and bacterial biofilm, etc.

Sponsors

The First Affiliated Hospital of Shenzhen University (Shenzhen Second People's Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Patients who voluntarily participated in the study and signed informed consent; 2. Patients with acute and chronic wounds of limbs; 3. Patients aged 14 years and above; 4. Patients who need surgical debridement; 5. There is a suitable test window area: located in the limbs, and can be smoothly placed to the spectrometer lens directly below the wound area.

Exclusion criteria

Exclusion criteria: 1. There were eschar, scab skin and other factors affecting wound observation and could not be removed during wound sampling in the test area, and the test area had severe skin diseases such as malignant tumors, rheumatic immune diseases, skin diseases and radiotherapy; 2. Other situations that the researcher considered inappropriate to participate in this study; 3. Currently participating or planning to participate in other device or drug clinical investigators during the study; 4. Patients or designated agents suffering from mental illness or other reasons can not be fully informed consent.

Design outcomes

Primary

MeasureTime frame
Wound bacterial species;Number of wound bacteria;bacterial drug resistance;

Secondary

MeasureTime frame
Wound bacterial biofilm;

Countries

China

Contacts

Public ContactJun Wu

The First Affiliated Hospital of Shenzhen University (Shenzhen Second People's Hospital)

junwupro@126.com+86 13983130289

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026