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A prospective, multicenter, self controlled, and highly effective clinical trial study on a personalized auxiliary diagnosis and treatment system for pathological scars based on artificial intelligence

A prospective, multicenter, self-controlled, superiority clinical trial of artificial intelligence-based personalized auxiliary diagnosis and treatment system for pathological scars

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500099415
Enrollment
Unknown
Registered
2025-03-24
Start date
2025-05-03
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

Pathological scar

Interventions

Gold Standard:The treatment opinions of senior plastic surgeons were used as the gold standard
Index test:To evaluate the severity of pathological scar, monitor the efficacy, and formulate personalized treatment plans based on artificial intelligence

Sponsors

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.According to the researcher's judgment, the subject meets the pathological scar diagnosis and the patient has a subjective willingness to receive treatment; 2.The patient's pathological scar has not been treated before, including surgery, radiotherapy, laser, corticosteroid injection, compression therapy, silicon gel dressing, cryotherapy, etc; 3. As this project is a non-interference observational study, the study itself does not intervene in the diagnosis and treatment of the subjects. The subjects voluntarily participate and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1.The pathological scars of the subjects have active infections (such as itching, pain, ulceration, pus discharge, etc.), or are combined with unhealed wounds and progressive skin diseases such as vitiligo, psoriasis, etc; 2.The subject refuses to participate in necessary follow-up in the later stage of treatment; 3.Except for pathological scars, the subjects have a history of severe organ diseases or active autoimmune diseases; 4.The subjects generally have poor conditions, are unable to move autonomously, or have multiple systemic diseases, and are unable to cooperate with macroscopic imaging collection and pathological scar blood flow perfusion measurement; 5.After the researcher determines that the subject has other systemic diseases that are not suitable for participation in this experiment, the abnormal laboratory test results will be determined by the researcher to determine whether they can be enrolled; 6. Subjects who have participated in other clinical trials within the first 30 days of the screening period; 7. Subjects who are unable to communicate and cooperate or do not follow guidance; 8. Other circumstances that the researcher deems unsuitable for participation in this experiment.

Design outcomes

Primary

MeasureTime frame
The treatment plan developed by 5 highly experienced plastic surgeons with at least 10 years of experience in plastic surgery for 400 patients with pathological scars will be used as the gold standard. Evaluate the performance of AI systems in assisting young plastic surgeons (experimental group), young plastic surgeons (control group), and AI groups in proposing the most suitable treatment recommendations, the consistency between the three groups and the gold standard treatment recommendations.;

Secondary

MeasureTime frame
Sensitivity;Specificity;Positive predictive;Negative predictive;The full compliance rate of the model;

Countries

China

Contacts

Public ContactLi Shuo

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

pumchzgykdxls@163.com+86 157 0156 0700

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026