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Multi-center clinical study based on self-developed near-infrared spectroscopy for accurate diagnosis of burn wound depth

Multi-center clinical study based on self-developed near-infrared spectroscopy for accurate diagnosis of burn wound depth

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900023695
Enrollment
Unknown
Registered
2019-06-08
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-06-29

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

Conditions

Burn

Interventions

Sponsors

The Second People's Hospital of Shenzhen
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) thermal burns (including electric burns), with a burned area of over 1%TBSA; (2) patients admitted within one week after injury; (3) patients who are likely to undergo surgical treatment (such as wound excision and skin grafts) or who are willing to undergo pathological biopsy with informed consent. (4) there are target wounds: burns, mixed or clinically unknown depth of wounds (including degree I, degree II, and degree III burns) were found in the injured area, except face.1%TBSA was taken as the test window area.If the selected test window area has a small possibility of wound surgery (such as patients with degree I or superficial degree II), then the concealed parts or non-functional parts are selected as the test window area. (5) those who can understand the study content and voluntarily agree to join the study; (6) subject (or designated agent) shall sign informed consent.

Exclusion criteria

Exclusion criteria: (1) patients with combined injuries with special injury-causing factors, such as radiation injury and chemical burns; (2) there are local diseases or systemic diseases that affect the diagnosis and evaluation of the wounds in the experimental area (such as diabetes combined with serious systemic complications (diabetic foot, diabetic skin disease), arterial occlusion or venous ulcer of the lower extremity, tumor, rheumatic immune disease, skin disease, radiation disease etc.); (3) other conditions considered inappropriate by the researcher to participate in this study; (4) currently participating in or planning to participate in other device or drug clinical research during the study period.(5)The patient or designated agent is mentally ill or otherwise unable to obtain full informed consent.

Design outcomes

Primary

MeasureTime frame
burn depth;

Secondary

MeasureTime frame
degree of burn depth;wound treatment;infection of the wound;Vital signs;

Countries

China

Contacts

Public ContactWu Jun

The Second People's Hospital of Shenzhen

junwupro@126.com+86 13983130289

Outcome results

None listed

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