Oral and maxillofacial tissue bleeding
Conditions
Interventions
Experimental group:Sprayable oxidizing nanocellulose gel
Control group:Imported liquid wound dressing
Sponsors
the Third Hospital Affiliated to Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: (1) Patients aged 18-50 years, without gender restriction; (2) Patients with oral and maxillofacial soft tissue defects caused by various reasons, and the wound needs to be covered by tissue transplantation; (3) No obvious suppurative infection patients; (4) Superficial injury - generally contusion, explosion injury patients; (5) Preoperative and postoperative hemostatic effect records could be completed, and four follow-up points were complete (the day after surgery, 7 days, 1 month, 6 months); (6) No special diseases affecting healing; (7) The subjects had good compliance, volunteered to be tested, and signed the informed consent.
Exclusion criteria
Exclusion criteria: (1) Contaminated or infected wounds or polar infected persons; (2) Patients with poorly controlled diabetes (fasting blood glucose =7.0mmol/L after drug control, or random blood glucose =11.1mmol/L, or HbA1c =6.5%); (3) Have participated in clinical trials of other drugs or medical devices within the last 3 months; (4) Patients with abnormal coagulation function or previous history of coagulation disorders (prothrombin time (PT), activated partial thromboplastin time (APTT)), international standardized ratio (INR), fibrin (FIB)), and considered clinically significant by investigators; (5) Taking anticoagulant drugs or other drugs that have an effect on the blood system within the past 14 days; (6) Abnormal liver and kidney function (ALT, AST more than 3 times the normal value; Creatinine and urea nitrogen/urea exceeded the normal range and were judged to be clinically significant by the investigators); (7) Patients with severe heart disease (i.e., New York Heart Function Scale (NYHA) level II and above); (8) mental abnormality without the ability to act autonomously; (9) Women who are pregnant, breastfeeding or planning to become pregnant within the next 3 months; (10) hypersensitive constitution (allergic to more than two kinds of drugs, specific constitution, polysaccharide allergy); (11) The wound area is less than 1.5cm2, greater than 24cm2 range; (12) HIV infected persons; (13) Scar constitution; (14) Other circumstances in which the physician determines that participation in the clinical trial is not possible.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemostatic time of maxillofacial soft tissue trauma;Healing rate and time of maxillofacial soft tissue trauma;Wound healing and scar condition; | — |
Secondary
| Measure | Time frame |
|---|---|
| Test quality control; | — |
Countries
China
Contacts
Public ContactTaiqiang Dai
the Third Hospital Affiliated to Air Force Medical University
Outcome results
None listed