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Evaluate the safety and efficiency of absorbarable dermis treatment III degree burn wounds prospective multicenter, randomized controlled clinical trials

evaluate the safety and efficiency of absorbarable dermis treatment III degree burn wounds prospective multicenter, randomized controlled clinical trials

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062748
Enrollment
Unknown
Registered
2022-08-17
Start date
2022-08-27
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

? degree burns

Interventions

Sponsors

Affiliated Hospital of Jiangnan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age >= 18, age <= 65, both sexes; 2. Patients with clinical diagnosis of third-degree burn and full-thickness skin defect; 3. The total burn area of burn patients was less than 50% total body surface area (TBSA), and degree ? was less than 20% total body surface area (TBSA); 4. Fresh scab wound was cut, and the area of the target wound was not more than 8cm x 8cm; 5. The subject will participate voluntarily and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Uncontrolled severely infected wounds; 2. Wounds with residual foreign bodies; 3. Patients with cardiovascular, liver (ALT, AST >1.5 times the upper limit of normal value), kidney (Cr> 1.5 times the upper limit of normal value), blood system and other serious primary diseases, mental illness, poorly controlled diabetes mellitus (fasting blood glucose >= 7.8mmol/L); 4. Tumors, patients receiving radiotherapy or chemotherapy; 5. Patients with asthma, urticaria and other allergic constitutions 6. Patients with known history of allergy to silk or porcine materials; 7. Those who cannot accept pig-derived materials due to religious beliefs, ethnic groups, etc.; 8. Patients who require medical treatment that may affect trial evaluation or require concomitant medical treatment that may affect efficacy evaluation; 9. Patients who have participated in drug clinical trials within 3 months, other medical device clinical trials within 1 month, and/or are currently participating in other interventional clinical trials and have not reached the end of the trial; 10. Pregnant or lactating women; 11. Patients deemed by the investigator to be ineligible for this trial.

Design outcomes

Primary

MeasureTime frame
Viability of the skin;

Secondary

MeasureTime frame
Skin scarring in the skin graft area.;

Countries

China

Contacts

Public ContactGuozhong Lyu
luguozhong@hotmail.com+86 13806183990

Outcome results

None listed

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