Deep burns, traumatic full-thickness skin defects, dermal defects of non-infected wounds in plastic surgery
Conditions
Interventions
Treatment group :Single Artificial Dermal Regeneration Matrix
Control group:Bilayer Artificial Dermal Regeneration Matrix
Sponsors
Shanghai Changhai Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 18-75 years old; 2) Meet the diagnostic criteria; 3) The area planned to use research products to repair and reconstruct dermal defects is not less than 4cm2 and not more than 200cm2; 4) Sign the informed consent form voluntarily.
Exclusion criteria
Exclusion criteria: 1) Those who have participated in other clinical trials within 90 days before the start of this trial; 2) Patients with malignant tumors who have received or plan to receive radiotherapy or chemotherapy during the trial period; 3) Patients with severe heart disease (ie, New York Heart Function Classification (NYHA) Class II and above); 4) Patients with abnormal liver and kidney function (ALT and AST exceed 3 times the normal value; creatinine and urea nitrogen exceed the normal range and the investigator judges it to have clinical significance); 5) Patients with coagulation dysfunction: coagulation function indicators (prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR), fibrinogen (FIB)) are abnormal, and the researcher believes that there is Clinically significant 6) Diabetes poorly controlled (fasting blood glucose is still =7.0 mmol/L after drug control, or random blood glucose = 11.1 mmol/L, or glycosylated hemoglobin (HbA1c) = 6.5%); 7) Wounds that have not healed after receiving more than 28 days of treatment and have no tendency to heal; 8) Incapable persons with mental disorders; 9) Pregnant women; 10) Women who are breastfeeding or planning to become pregnant within the next 6 months; 11) After preparation of the wound bed, the wound can not be cleaned, or the blood supply of the wound is insufficient; 12) Wounds with open joint cavity; 13) Bone tendon exposed wounds (except for wounds covered by treatment or surgical treatment of the exposed bone and tendon tissue before artificial dermis transplantation); 14) Those deemed inappropriate by other researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skin graft survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Good and good rate of skin graft survival;Vancouver scar scale; | — |
Countries
China
Contacts
Public ContactZhaofan Xia
Shanghai Changhai Hospital
Outcome results
None listed