burn
Conditions
Interventions
A:left(up):Decrustation Ointment right(below):Intrasite Gel
B:left(up):Intrasite Gel right(below):Decrustation Ointment
Sponsors
Changhai Hospital
Eligibility
Sex/Gender
All
Age
15 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Deep II degree burn patients, the overall surface area (TBSA) 1-30%, can be observed on a single wound is not less than 50-100cm2, not greater than TBSA 10%; 2. Aged 15-70 years old, men and women are not limited; 3. Outpatient or inpatient, within 7 days after the injury to the hospital; 4. Women of childbearing age should have effective contraceptive methods during the trial period; 5. Patients fully understand and voluntarily sign informed consent; 6. Be able to comply with the test requirements and be able to complete all follow up.
Exclusion criteria
Exclusion criteria: 1. Allergy or hypersensitivity to the known components of the formulation; 2. Diabetes mellitus, malignant tumor, chronic wasting disease; 3. Patients with severe heart, liver, kidney and blood system complications; 4. Vascular lesions of the extremities; 5. At the same time using Recombinant Human Epidermal Growth Factor Gel as a wound treatment of patients with drugs; 6. Patients with immune disorders or application of hormone drugs; 7. Female patients who are pregnant or breastfeeding or who are prepared to be pregnant during the trial; 8. The researchers believe that the patient's previous or current physical or mental condition is likely to be dangerous in the course of the trial, interfere with the test evaluation or interfere with the patient to participate in the test; 9. In severe and difficult to control the local or systemic acute and chronic infection period; or the history of active tuberculosis or in the treatment of tuberculosis patients; 10. Clinical trials of patients attending other drugs or devices within 30 days; 11. Other conditions that the researchers considered were not appropriate for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healing of wound area ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound healing days;The ratio of necrotic tissue area and the area of the wound;The ratio of wound infections;Pain Grade; | — |
Countries
China
Contacts
Public ContactZhuo Wang
Changhai Hospital
Outcome results
None listed