Secondary wound infection
Conditions
Interventions
experimental group 1:1‰ antimicrobial peptides PL-5 sprays (5 mg:5mL), spray administration
experimental group 2:2‰ antimicrobial peptides PL-5 sprays (10 mg:5mL), spray administration
experimental group 3:4‰ antimicrobial peptides PL-5 sprays (20 mg:5mL), spray administration
positive control group:1% Sulfadiazine Silver Cream, smear administration
Sponsors
Shenzhen Second People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged from 18 to 75 (including the threshold) years, regardless of gender; 2. Open wound patients with secondary infection, such as burns, abrasions, scratches, lacerations, sutured wounds, traumatic ulcers, pressure sores, venous ulcer infections or diabetic foot ulcers with Wagner grade 2, etc., and meet the following conditions: (1) The length of the cut, tear or suture wound shall not exceed 10 cm, the surrounding erythema shall not exceed 2 cm, and the area of the burn, scratch, ulcer, pressure sore and other wounds shall not be less than 4 cm2; (2) The clinical symptoms of wound infection met the following conditions: skin infection rating scales (SIRS) (Appendix 1) >= 8 points; (3) No deep soft tissues such as deep fascia and muscle were involved; (4) Local medication is needed; 3. Patients who received bacteriological sample collection and were found to be positive by microscopy; 4. Male subjects or female subjects of childbearing age agree to take effective and safe contraceptive measures during the treatment period and within one week after the treatment (definition of female in childbearing age: female who does not undergo sterilization from menarche to menopause and is able to pregnancy in anatomy and physiology); 5. Patients who agree to comply with the prohibitions and restrictions specified in the program and understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will not be allowed to enter the test: 1. Objects not cultured with bacteria before enrollment; 2. Patients who had been treated with systemic antibiotics or antibiotics for the experimental wound within 72 hours prior to enrollment. However, according to the researcher's judgment, the infection signs can still be included; 3. Patients with mild skin infection, such as furuncles, acne, folliculitis, pustules and so on, which can be cured only by simple surgical treatment or active local care; 4. Patients with one of the following wound infections: (1) The infection of the wound was known or suspected to be caused by fungi, parasites or viruses; (2) There was rapid necrosis in the wound, such as necrotizing fasciitis; (3) There are inflammatory skin diseases, such as atopic dermatitis or eczema, which affect the evaluation of efficacy and safety; (4) There were artificial materials that could not be removed in the wound, such as central venous catheter, battery pack of permanent pacemaker, or artificial joint; (5) The wounds were acral multiple ulcer; (6) Wagner's grade (Appendix II) was 0-1, 3 and above diabetic foot ulcer; (7) Gangrene of any cause. 5. Patients who need amputation; 6. Allergy to any substance of the research drug (including antimicrobial peptide PL-5 spray and Sulfadiazine Silver Cream), or allergic to sulfonamide or silver salt, or allergic diseases. 7. Pregnant or lactating women. If the lactating female subjects agree to stop lactation during the treatment period and within one week after the last medication, they can still be included; 8. Patients with the following laboratory abnormalities during the screening period: (1) With or suspected of liver dysfunction, or total bilirubin > 3 times the upper limit of normal value, or ALT or ast 5 times the upper limit of normal value [ULN]; (2) Dialysis with or suspected of severe renal impairment (such as serum creatinine [SCR] > 3 times the upper limit of normal value) or any form of dialysis; (3) Neutropenia (absolute neutrophil count [ANC] <= 1.5x10^9/l) or platelet count < 50x10^9 / L; 9. Patients with grade III or IV cardiac dysfunction meeting NYHA standard (Appendix III); 10. Patients with immune deficiency, such as those with congenital immune deficiency, being treated with immunosuppressant or HIV positive; 11. Patients who were using chemotherapy drugs at the time of screening; 12. Patients with mental disorders or epilepsy; 13. Patients who have participated in clinical trials of drugs or devices within 3 months before screening; 14. In the opinion of the investigator, any situation that may increase the risk of the subject or affect the efficacy evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficiency on day 1 after last administration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical efficacy on day 5;Bacterial clearance at day 5 after administration;Bacterial clearance on day 1 after last administration;Combined effect on day 1 after the end of last administration;Combined effect 5 days after administration; | — |
Countries
China
Contacts
Public ContactWu Jun
Shenzhen Second People's Hospital
Outcome results
None listed