Deep second- degree burn
Conditions
Interventions
control group: VERSAJET II debridement waterjet system+ UrgoTul SSD
Sponsors
The First Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Between ages of 18 and 70 years male and female; (2) Deep second- degree burns caused by heat such as hydrothermal fluid, flame, arc, steam, etc. [5], the total area of burn wounds is 2% to 50% of total body surface area (TBSA) [5,6]; (3) Burn wounds are located in the non-articular functional parts of the trunk and limbs; (4) The wound area of 100 cm2 +/-10% that meets the standard of admission is the test window area. (For the remaining burn wounds, according to the judgment of the researcher and the patient's will, the corresponding method is used for wound treatment); (5) Those who are able to understand the test content and voluntarily agree to conduct the test; (6) The investigator determined that the patient was suitable for debridement with a waterjet.
Exclusion criteria
Exclusion criteria: (1) Pregnant and lactating women; (2) Those who have undergone wound surgery in the past 30 days; (3) Those who require systemic immunosuppressive therapy (including glucocorticoids), cytotoxic drugs, and anticoagulant drugs in the past 30 days or during the expected study period; (4) Those who are currently participating in or planning to participate in other devices or drug clinical investigators during the study period; (5) Patients with hematopoietic dysfunction and coagulopathy (such as hemophilia); (6) Those with diabetes, vascular disease (including peripheral vascular disease, vasculitis, etc.), pyoderma or lymphedema; (7) Those with severe acute organ dysfunction or dysfunction, including: severe cardiac insufficiency (heart function level III and above), severe hypertension (blood pressure > 160/100 mmHg), severe arrhythmia ( Heart rate > 160 beats / min), abnormal liver function (alanine aminotransferase (ALT) >2 times the upper limit of normal value, abnormal renal function (hemoresin > 1.5 times the upper limit of normal), etc.) or multiple organ failure; (8) Those with serious underlying diseases such as autoimmune diseases, malignant tumors, and tuberculosis; (9) Acquired immunodeficiency syndrome (AIDS) patients or patients infected with human immunodeficiency virus (HIV); (10) Those with poor systemic nutritional status and low immune function; (11) concurrent with acute or chronic bacterial, viral or fungal skin diseases that may interfere with wound healing; (12) Those with mental illness or mental disorder; (13) Poor treatment compliance; (14) Patients with shock and severe systemic infection; (15) Patients with chemical burns [6] or burns of special causes such as radioactive burns [7]; (16) Other conditions that are not suitable for enrollment by the investigator, such as: inability to tolerate debridement, difficult follow-up, combined with other wound debridement to affect the debridement effect of waterjet.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Necrotic tissue clearance success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| necrotic tissue clearance rate;Debridement time;Percentage reduction of wound area;Assessment of wound infection;Instrument performance evaluation; | — |
Countries
China
Contacts
Public ContactJun Wu
the First Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed