Oral and maxillofacial soft tissue defects
Conditions
Interventions
Experimental group:Lando oral absorbable biofilm
Control group:Haiao oral repair film
Sponsors
Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: [1] Age: 18-75 years old; [2] Oral and maxillofacial soft tissue defects caused by various reasons, and tissue transfer is required for the wound patients with plant coverage; [3] Those who voluntarily participate in this clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: [1] Those who have participated in other clinical trials within 90 days* prior to the start of this trial; [2] Those who have received radiotherapy or chemotherapy within 90 days* prior to the start of this trial; [3] Patients with severe cardiac disease (i.e., those with NYHA Class II and above); [4] Patients with abnormal liver and kidney function (ALT, AST more than 3 times the normal value; Creatinine, urea nitrogen/urea exceeding the normal range value and judged by the investigator to be clinically significant); [5] Patients with poorly controlled diabetes mellitus (fasting blood glucose = 7.0 mmol/L after medication control, or random blood glucose = 11.1 mmol/L, or glycosylated hemoglobin (HbA1c) =6.5%); [6] Those with severe autoimmune diseases; [7] HIV-infected individuals; [8] Patients with bleeding tendency or coagulation dysfunction: abnormal platelet count, abnormal coagulation function (prothrombin time (PT), activated partial thromboplastin time (APTT)), international normalized ratio (INR), fibrin (FIB), and those who are considered clinically significant by the investigator; [9] Incapacitated persons with mental abnormalities; [10] Females who are pregnant, lactating, or preparing to become pregnant within the next 3 months**; [11] Patients with acute infection at the defect site; [12] The wound area is less than 1.5 cm2 and greater than 24 cm2 [13] Other investigators who are considered unsuitable to participate in this trial. Note*: The start time here refers to the time when the subject signs the informed consent form. Note**: Refers to women who are planning to become pregnant within 3 months of using the investigational product.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Surgical area satisfaction;Evaluation of wound contractures;Wound healing rate; | — |
Primary
| Measure | Time frame |
|---|---|
| Wound healing rate; | — |
Countries
China
Contacts
Public ContactJianhua Wei
Air Force Medical University
Outcome results
None listed