Deep Second Degree Burns
Conditions
Interventions
Treatment group:Autologous cell separator combined with conventional mesh implantation
Control group:conventional mesh implantation
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subjects participating in this clinical study must meet all of the following enrollment criteria to be enrolled in this study: 1) Subjects are 18-65 years of age (both 18 and 65) and are of either gender; 2) Subjects require autologous skin grafting due to burns; 3) Deep second-degree burn wounds with a total burn area of 5-30% total body surface area (TBSA); *Clinical features of deep II degree burn wounds [1]: blister skin rupture or removal of putrefied skin, red and white wounds or visible network of finely embolized blood vessels, excessive wound exudation, marked edema, dulled nociception, and minimal pain with hair-pulling or pinprick tests. (4) The treatment area of a single wound in deep second-degree burns is 100-320 cm2; 5) Unless medically necessary, subjects were not allowed to undergo any other treatment on the study intervention wound during the study period; 6) Subjects voluntarily participate in the clinical study and agree to sign an informed consent form; 7) The subject agrees not to participate in any other clinical trials during the study period; 8) The subject is able and willing to comply with the requirements of the protocol and is willing to complete all follow-up assessments required by the study protocol.
Exclusion criteria
Exclusion criteria: Subjects participating in this clinical study will not be enrolled in this study if they meet any of the following exclusion criteria: 1) Female patients of childbearing potential who are pregnant, lactating, or planning to become pregnant during the study period; 2) Patients with a known allergy to complex sodium lactate solutions; 3) Patients with known hypersensitivity to anesthetics, epinephrine, povidone-iodine or chlorhexidine solutions; 4) patients with unstable vitiligo; 5) Patients with clinical infection or necrosis that may interfere with wound healing; 6) Subjects with diseases that may interfere with wound healing (e.g., malignant tumors, uncontrolled diabetes mellitus, autoimmune diseases, etc.); (7) Patients with hematopoietic dysfunction and coagulation disorders (e.g., hemophilia); (8) Patients who have tested positive for human immunodeficiency virus (HIV), hepatitis B or C virus, and syphilis helix-specific antibodies (RPR); 9) Current use of medications that, in the opinion of the investigator, may compromise patient safety or study objectives (e.g., long-term use of immunosuppressants, anticoagulants, corticosteroids, etc., that affect wound healing); 10) Those with suspected or established alcohol, drug, or substance addiction; 11) Participation in any other clinical trial within 30 days prior to signing the informed consent form (except for registry studies) 12) Subjects with concurrent conditions that, in the opinion of the investigator, may compromise patient safety or the objectives of the study; 13) other conditions that, in the opinion of the investigator, make participation in this clinical study inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Postoperative wound healing time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete wound healing rate within 4 weeks after surgery;The wound healing rate;Number of dressing change;Pain score;Scar score;Assessment of wound condition; | — |
Countries
China
Contacts
Public ContactYan Liu/Liang Qiao
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed