skin dermis defect
Conditions
Interventions
test group:Medical recombinant collagen absorbable repair dressing
control group:Pelnac Absorbable Dressing
Sponsors
the First Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) The following diseases and skin dermis defects caused by trauma require dermis repair and reconstruction: (1) III degree burns; (2) traumatic skin defect; (3) Skin defects after resection of tumors, ulcers, birthmarks, etc.; (4) Skin flap removal site, etc.; 2) Age = 18 and = 65; 3) Target wound Minimum area = 20 cm2, Maximum area = 200 cm2; 4) Patients who agree to participate in this clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Have a history of allergies to collagen products; 2) Severe infection of the target wound, incomplete debridement, severe necrosis of the injured limb, or wounds in special parts (perineum, head, face and neck); 3) Moderately or poorly controlled diabetes (HbA1c > 7%), or vascular disease; 4) The area of dermal defect that needs to be repaired and reconstructed exceeds 10% of the total body surface area (TBSA); 5) The total burn area exceeds 30% of the total body surface area (TBSA); 6) Radiation ulcers, or malignant lesions in ulcers, or after malignant tumor resection; 7) Those who are currently receiving radiotherapy and chemotherapy or taking hormones and immunosuppressants; 8) Existing diseases will seriously affect wound healing, such as severe anemia (Hb 2.5 times the upper limit of normal value; kidney function: Serum creatinine > 1.5 times the upper limit of normal; severe respiratory dysfunction); 10) Have serious mental illness, including severe hysteria, and do not have autonomy; 11) Pregnant or breastfeeding women, or those who have family planning during the study; 12) Have a history of severe cerebrovascular accidents or/and severe limb skin autonomic dysfunction and other diseases; 13) Participated in other clinical trials in the past 3 months; 14) Suffering from infectious diseases such as HIV, HBV, HCV or syphilis; 15) According to the investigator's judgment, any medical history that may interfere with the test results or increase the risk of the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness of treatment on day 7 after skin grafting; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vancouver Scar Score;Treatment response rate on days 10 and 14 after skin graft surgery;Pain Scale;The number of days between the first surgery and the second surgery;Hospital stay after device implantation; | — |
Countries
China
Contacts
Public ContactSun Yu
the First Affiliated Hospital of Naval Medical University
Outcome results
None listed