Oral soft tissue defects
Conditions
Interventions
Experimental group:Absorbable Soft Tissue Repair Membrane
Control Group:Oral Repair Membrane
Sponsors
West China Hospital of Stomatology, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 70 years inclusive, regardless of gender; 2. Patients with superficial oral soft tissue defects of various etiologies requiring wound coverage with a repair membrane; 3. Individuals who agree to participate in this clinical trial and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Use of oral membrane materials (e.g., for soft tissue augmentation, defect repair, etc.) at the target wound site within 6 months prior to surgery; 2. Presence of local infection at the defect site or systemic infection; 3. Single wound area 25 cm^2; 4. Poorly controlled diabetes (fasting blood glucose =8.8 mmol/L or 2-hour postprandial blood glucose >=11.1 mmol/L); 5. History of radiotherapy prior to surgery or chemotherapy within 6 months before surgery; 6. Hepatic or renal insufficiency (ALT, AST, or Scr >2 times the upper limit of normal); 7. Severe coagulation disorders (PT or APTT >2 times the upper limit of normal); 8. Hypoalbuminemia (serum albumin <30 g/L) or cachexia; 9. Diagnosis of autoimmune diseases; 10. Intolerance to surgery or contraindications for surgical procedures; 11. Allergy to collagen or materials of ovine (sheep) or bovine (cattle) origin; 12. History of alcohol abuse or substance misuse; 13. Pregnancy or lactation, or planning pregnancy during the study period; 14. Current participation in other interventional drug or device clinical trials without having reached the primary endpoint; 15. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Grade A Healing Rate of the Target Wound at 1 Month Postoperatively; | — |
Countries
China
Contacts
Public ContactLing Ye
West China Hospital of Stomatology, Sichuan University
Outcome results
None listed