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Application of recombinant human collagen microneedles in non healing wounds after burns

Application of recombinant human collagen microneedles in non healing wounds after burns

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500099557
Enrollment
Unknown
Registered
2025-03-25
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-31

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

Conditions

Wound

Interventions

Control group:After joining the group, the wound was thoroughly cleaned, disinfected twice with chlorhexidine, rinsed once with physiological saline, and externally applied with sulfamethoxazole silve
Experiment group:After enrollment, the wound was thoroughly cleaned, disinfected twice with chlorhexidine, rinsed once with physiological saline, covered with collagen microneedles, and wrapped with s

Sponsors

Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 16 Years

Inclusion criteria

Inclusion criteria: 1. Research participants treated in the clinical trial center of this project from April 1, 2025 to December 31, 2025; 2. Age between 8~16 years old, gender is not limited; 3. Diagnosis of refractory wound after burn, that is, there is no sign of healing after 8 weeks of onset and regular treatment; 4. Wound area <=5% TBSA; 5. The wound is located in the limbs and trunk; 6. Confirmed by the clinician, the wound needs to be treated with dressings; 7. Those who agree to participate in this study and sign a written informed consent form; 8. There are no other non-compliances.

Exclusion criteria

Exclusion criteria: 1. Accompanied by life-threatening underlying diseases, such as high-risk coronary heart disease, etc.; 2. Accompanied by diabetes, hypertension, autoimmune diseases and other underlying diseases that significantly affect wound healing; 3. Research participants who are unable to cooperate well, such as those with mental illness, or poor compliance; 4. Those who are known to have a history of allergy or allergic constitution (allergy to 2 or more allergens) that are similar to the ingredients or other chemical structures contained in this product and the reference substance; 5. Pregnant or lactating women and those with birth plans; 6. Those who have participated in other clinical studies within 1 month before selection; 7. Research participants who cannot be followed up for a long time; 8. Study participants who refuse to sign written informed consent; 9. Those who have other investigators who think it is not suitable to participate in clinical research.

Design outcomes

Primary

MeasureTime frame
Wound healing rate;Wound healing time;

Countries

China

Contacts

Public ContactZhu Shihui

Shanghai Jiao Tong University School of Medicine Affiliated Children's Medical Center

jinjiannavy@163.com+86 139 0197 1974

Outcome results

None listed

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