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A multicenter, open-label, randomized, parallel-controlled, non-inferiority clinical trial evaluating the safety and efficacy of artificial dermis

A multicenter, open-label, randomized, parallel-controlled, non-inferiority clinical trial evaluating the safety and efficacy of artificial dermis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072399
Enrollment
Unknown
Registered
2023-06-12
Start date
2022-03-01
Completion date
Unknown
Last updated
2023-06-18

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

Conditions

Partial thickness burn

Interventions

Experimental Group:Treated with Permeaderm B
Control Group:Treated with Porcine skin acellular dermal matrix dressing

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) The age of the subjects is 18 to 65 years old, and the gender is not limited; 2) Subjects whose target wounds are second-degree burn wounds within 72 hours after burn; 3) Subjects with a maximum length of the target wound <20cm and a maximum width perpendicular to the maximum length <20cm; 4) Subjects whose total wound area is less than 30% of the total body surface area; 5) Subjects who agree to participate in this trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) Infectious burn wounds; 2) Electrical or chemical burns; 3) Subjects with third-degree wounds determined by the researchers after the target wounds that need to be scabbed are scabbed; 4) Persons with severe infection; 5) Hemoglobin (HGB) 47s, or prothrombin time (PT)>14s; 8) Patients with severe primary diseases such as cardiovascular, liver (ALT>300U/L or AST>200U/L), kidney (BUN>20mmol/L or Cr>445µmoI/L) or blood system; 9) Diabetic patients; 10) Pregnant or lactating women; 11) Patients with a history of mental illness, alcoholism or drug addiction; 12) Those who are allergic to pigs or aloe vera materials; 13) Those who cannot accept pig-derived materials due to religious beliefs, ethnicity and other issues; 14) Poor compliance and unable to complete the researcher; 15) Those who have participated in other clinical trials in the past 1 month; 16) Subjects deemed inappropriate by the investigator to participate in the trial.

Design outcomes

Primary

MeasureTime frame
wounds healing ratio;

Secondary

MeasureTime frame
Number of subjects with wound healing;wounds healing time;VAS score;Evaluation of device operation performance;

Countries

China

Contacts

Public ContactXia Zhaofan

Shanghai Changhai Hospital

xiazhaofan@163.com13761969853

Outcome results

None listed

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